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Reported trial results for Stroke

Every Stroke trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.

153 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

  • NCT05906602 · results posted 23 February 2026

    According to the results reported on ClinicalTrials.gov, this trial involved 20 people who had experienced a stroke (11 in one group, 9 in the other). It used a "crossover" design, meaning participants tried both the real procedure — called ischemic conditioning, which involves briefly reducing blood flow to a limb using a cuff — and a sham (pretend) version of the same procedure, just in different orders. The trial was measuring several things related to brain and muscle function in the leg: how excitable the brain's movement-control area was, how much one side of the brain was "quieting down" the other side, how quickly participants could react with ankle movements, and how much lower-leg strength they had. The reported data shows the following numbers after each condition. For brain excitability (measured in millivolts), the ischemic conditioning group recorded 0.41 mV and the sham group recorded 0.37 mV. For the brain's cross-hemisphere quieting effect (measured in milliseconds), the ischemic conditioning group recorded 133.9 ms and the sham group recorded 118.8 ms. For ankle reaction time (also in milliseconds, where lower is faster), the ischemic conditioning group recorded 0.52 ms and the sham group 0.53 ms. For lower-leg strength (in pounds of force), the reported data shows figures ranging from roughly 3.6 to 4.7 across the two conditions and different movement directions. As a secondary measure, participants were asked to rate any discomfort during the cuff procedure on a scale of 0–10; the ischemic conditioning group reported an average score of 1.1 and the sham group reported 1.0, both at the low end of the scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04993079 · results posted 23 January 2026

    According to the results reported on ClinicalTrials.gov, this trial enrolled 45 participants, all in a single group (there was no comparison group). Thirty-nine participants completed the trial, and six did not. The trial was testing a device called Clotild®, which is a sensor-based tool designed to measure the electrical properties of a blood clot blocking a brain artery — with the goal of identifying what the clot is made of (for example, whether it contains mostly red blood cells or platelets). This kind of information could help guide stroke treatment decisions during a procedure to remove the clot. The reported data shows that, for the main safety-related question — how many participants experienced a perforation (a hole) or dissection (a tear) of a blood vessel in the brain caused by the Clotild® device — the answer was zero out of the participants assessed. For the main performance question, the device's ability to tell apart regions of a clot with a high red blood cell content from regions with a low red blood cell content was measured using a scoring method called AUC (a value between 0 and 1, where 1 would mean perfect accuracy and 0.5 would mean no better than chance). The reported AUC value was 0.97. For the secondary outcomes, the device's ability to distinguish areas of the clot with high platelet content returned an AUC of 0.94, and its ability to detect where the clot begins returned an AUC of 0.66. The reported data shows that 26 out of 45 participants had the device successfully navigated to the clot site with at least one usable measurement recorded. A separate measure comparing the device's overall clot composition estimate to laboratory examination of the retrieved clot returned a slope value of 0.19 (a figure describing how closely the two measures tracked each other, where a value of 1 would indicate a perfect match). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04309474 · results posted 22 December 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04309474) enrolled 121 people in total — 60 in the placebo group and 61 in the elezanumab group. The trial was measuring stroke severity and functional recovery in people who had experienced a stroke. The main thing being tracked was a standard stroke severity score called the NIHSS (National Institutes of Health Stroke Scale), which runs from 0 to 42, where higher numbers indicate greater impairment. A secondary measure looked at how many participants reached a certain level of recovery on a disability scale called the Modified Rankin Scale (mRS), which runs from 0 (no symptoms) to 5 (severe disability), with 6 indicating death. The reported data shows that, when stroke severity scores were averaged out over the treatment period using a mathematical method to capture the overall trend across multiple time points, the placebo group had an average score of 3.83 and the elezanumab group had an average score of 3.13, both on the 0–42 NIHSS scale. For the secondary measure, the reported data shows that 28 out of 60 participants in the placebo group and 29 out of 61 in the elezanumab group were counted as "responders" on the disability scale. It is worth noting that not everyone completed the study — 39 people in the placebo group and 41 in the elezanumab group finished, with around 20–21 in each group not completing it; reasons for this were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03142841 · results posted 18 December 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 105 people in a Standard Care group and 105 people in an Intervention group (called a Problem Solving Intervention), for a total of 210 participants. The trial was measuring outcomes for **caregivers** — people who look after someone else, such as a family member with an illness. By the end of the study, 86 people in the Standard Care group and 70 in the Intervention group had completed the trial; the remaining 19 and 35 participants respectively did not finish. The trial tracked three things over roughly 9 weeks and 21 weeks: caregiver depression (using a questionnaire scored 0–60, where higher means more depressed), caregiver burden (scored 0–88, where higher means more burden), and caregiver confidence in asking for a break from caring (scored 0–100, where higher means more confident). The reported data shows the following scores at 9 weeks: for depression, the Standard Care group scored 15.0 and the Intervention group scored 10.2 (out of 60). At 21 weeks, those scores were 14.3 and 10.5 respectively. For caregiver burden at 9 weeks, the Standard Care group scored 30.3 and the Intervention group scored 24.5 (out of 88); at 21 weeks the scores were 30.8 and 23.2. For confidence in asking for a break, at 9 weeks the Standard Care group scored 45.6 and the Intervention group scored 54.2 (out of 100); at 21 weeks those scores were 41.0 and 57.2. The reported data shows score differences between the two groups across all three measures and both time points, but this summary describes only the numbers as submitted — it does not assess whether any differences are meaningful or what may have caused them. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02483429 · results posted 9 December 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT02483429) enrolled 130 people who visited an emergency department (ED) with dizziness or balance problems — 65 in each group. One group received a new approach called VOG-guided Rapid Triage (VRT) Care, which used specialised eye-movement recordings (video-oculography, or VOG) to help guide diagnosis. The other group received the usual standard of care (SOC) that emergency departments normally provide, which could include brain scans and specialist consultations. The trial was measuring how accurately each approach identified the cause of dizziness, how much each approach cost in diagnostic tests and consultations, and whether getting an incorrect diagnosis was linked to more health events (such as falls or return ED visits) in the short term. The reported data shows the following numbers for the main outcomes, looking only at participants who completed the full set of required follow-up assessments. For diagnostic accuracy across six possible diagnosis categories, 24 out of 57 VRT participants were correctly diagnosed, compared with 18 out of 56 SOC participants; 33 VRT participants and 38 SOC participants were recorded as incorrectly diagnosed. For diagnostic costs during the ED visit, the reported average was approximately US$3,007 per person in the VRT group and approximately US$3,599 per person in the SOC group. Regarding short-term medical events of interest (such as falls, return ED visits, or vascular events) in the SOC group only, 1 out of 17 people who received a correct SOC diagnosis experienced such an event, compared with 3 out of 35 people who received an incorrect SOC diagnosis. For a secondary measure comparing stroke versus no-stroke accuracy, the reported data shows variation in correct and incorrect classifications between the two groups, though some category-level figures were not fully labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT06733103 · results posted 3 December 2025

    According to the results reported on ClinicalTrials.gov, this trial involved 10 people in total — 5 stroke survivors and 5 carers (people who look after someone who has had a stroke). One person from each group did not complete the study, leaving 4 stroke survivors and 4 carers whose data was used. The trial was examining how acceptable a particular intervention or approach felt to participants, using in-depth interviews guided by a research tool called the Theoretical Framework of Acceptability (TFA). This framework breaks acceptability down into 7 different aspects, or "constructs," to capture a fuller picture of how people feel about something they have experienced. The reported data shows that researchers counted how many participants from each group said something meaningful about each of the 7 acceptability aspects during their interviews. For most of the aspects reported, all 4 stroke survivors and all 4 carers provided relevant responses. The reported data shows one aspect where 3 out of 4 stroke survivors (compared to all 4 carers) contributed meaningful responses — the data for the remaining aspects was not broken down individually in what was submitted, so a full construct-by-construct comparison cannot be described here. The researchers note that the stroke survivor and carer data were analysed separately, so only the counts above can be directly compared between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT05469438 · results posted 2 December 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 30 participants, all of whom completed the study — none dropped out. The trial was a single-arm study, meaning everyone received the same intervention with no comparison group. It was testing whether a sensor system that tracks how a person moves (measuring things like speed and position) could accurately predict how much a stroke survivor's arm movement would recover by the end of the study, based on information collected on the very first day. The reported data shows that the trial's main measurement was something called the coefficient of determination, written as R². In simple terms, R² is a number that shows how well a prediction model's estimates match what actually happened — a value of 1 would mean perfect prediction, while lower values mean less accurate prediction. The best-performing model reported an R² of 0.9, meaning it closely matched the actual arm recovery scores (measured using a standard arm movement scale called the Fugl-Meyer Upper Extremity score) when tested across the 30 participants. No other outcome measures were reported in the submitted data. It is worth noting that this was a small, single-group study focused on testing a predictive tool, not on comparing treatments. The reported data shows only how well the model predicted scores — no other outcomes, such as side effects or quality of life, were included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01976936 · results posted 1 December 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 162 people who had experienced a stroke — 81 in a "Standard" dose group and 81 in a "High Dose" group. The trial was measuring outcomes related to statin (cholesterol-lowering) medication dosing after stroke, and tracked both potential signs of harm to the liver or muscles, and measures of neurological and functional recovery. Of those who started, 72 in the Standard group and 77 in the High Dose group completed the study. The reported data shows that when it came to the primary measure — the number of participants who showed notable increases in liver or muscle enzyme levels within 7 days of starting treatment — 1 person in the Standard group and 2 people in the High Dose group met that threshold. For the secondary measures, average stroke severity scores (on a scale of 0–42, where higher means more impairment) were reported as 2.5 for the Standard group and 3.3 for the High Dose group at the measured time point. When looking at day-to-day independence (Barthel Index, scored 0–100), 46 participants in the Standard group and 38 in the High Dose group scored above 95, indicating a high level of independence. For disability level (modified Rankin Scale, scored 0–6), 29 participants in the Standard group and 31 in the High Dose group scored 0–1, indicating little to no disability. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT06029959 · results posted 8 October 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT06029959) enrolled 36 participants in a single group called the "SCOUTS3 Optimization Arm." Of those, 30 participants completed the study and 6 did not finish. The trial was measuring how consistently participants used CPAP — a breathing device worn during sleep — over a three-month period that covered both their time in inpatient rehabilitation and afterwards. The reported data shows that the primary outcome measured was CPAP adherence, meaning the average number of hours per night that participants used their CPAP device. According to the results reported on ClinicalTrials.gov, the average nightly CPAP use across the three-month period was 3.1 hours. No secondary outcome measures were included in the submitted results data. It is worth noting that no comparison group (such as a control or placebo group) was part of this trial, so the reported figure reflects only this one group of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT05417009 · results posted 14 July 2025

    According to the results reported on ClinicalTrials.gov, this trial involved 36 people in total, split into two equal groups of 18. One group received a form of stimulation (the exact type is not described in the data provided), while the other group had electrodes attached but received no stimulation — acting as a comparison group. The trial was measuring variability in blood pressure, meaning how much a person's blood pressure fluctuated over time, rather than simply what their blood pressure was at a single point. The reported data shows that for the primary measure — how much systolic blood pressure (the top number in a blood pressure reading) varied, expressed as a "coefficient of variation" (a way of describing the size of fluctuations relative to the average) — the stimulation group recorded a value of 0.106 and the electrode-only group recorded 0.107. For the first secondary measure, systolic blood pressure variability was also described using a standard deviation (another way of capturing how spread out the readings were), and both groups recorded the same figure of 14 mmHg. For the second secondary measure, diastolic blood pressure variability (the bottom number in a blood pressure reading), the stimulation group recorded a coefficient of variation of 0.136, compared with 0.127 in the electrode-only group. All 36 participants who started the trial completed it, with no dropouts reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05762679 · results posted 9 July 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 42 adults who had experienced a stroke and were living with shoulder pain on the affected (paretic) side of their body. Two participants did not complete the study, leaving 40 who finished. The trial was not testing a new treatment — instead, it was a measurement study looking at whether certain physical properties of shoulder muscles differed between the stroke-affected side and the unaffected side of the same person. The researchers used two types of scans: a specialised MRI technique (called T1 rho, which measures how water behaves in muscle tissue) and an ultrasound technique that measures how much muscles deform or "shear" when moved. The reported data shows the following numbers from those scans. For the MRI measurements, the stroke-affected shoulder's external-rotation muscle (infraspinatus) recorded a relaxation time of 29.09 milliseconds, compared with 27.15 milliseconds on the unaffected side. The internal-rotation muscle (pectoralis major) recorded 31.83 milliseconds on the affected side versus 30.96 milliseconds on the unaffected side. For the ultrasound shear measurements — which look at how much the chest muscles deform — the affected side recorded a shear strain of 46.54%, compared with 35.37% on the unaffected side across all participants. When looking only at participants with more severe shoulder pain, the reported figures were 47.46% on the affected side versus 35.67% on the unaffected side. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT05277389 · results posted 25 June 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT05277389) involved 21 people who had experienced a stroke — 11 in a control group and 10 in a group called "START." The trial was measuring arm and hand movement ability, and how much people actually used their affected arm in everyday life. Two main tools were used: the Action Research Arm Test (ARAT), which scores arm and hand tasks out of 57, and the Motor Activity Log (MAL), which rates how much a person uses their arm in daily activities on a scale of 0 to 5. Not everyone finished — 10 of the 11 control participants and 6 of the 10 START participants completed the study. The reported data shows that on the ARAT arm function test, the control group's score changed by an average of +0.72 points from the start to the end of the intervention, while the START group's score showed no change (0 points). At a follow-up check some time later (called "retention"), the control group's score had gone up by 1 point on average, while the START group's score had decreased by approximately 0.67 points. For the MAL daily arm-use scale, the control group's average score went down by about 2.05 points over the intervention period, while the START group's score went up by approximately 0.39 points. At the retention follow-up, both groups showed higher MAL scores than at the end of the intervention — the control group by about 5.06 points and the START group by about 12.75 points. The reported data also shows results from a secondary measure — the Fugl-Meyer Upper Extremity assessment, another arm function scale scored out of 66. From the start to end of the intervention, the control group's score changed by roughly +0.09 points on average, while the START group's score changed by approximately +1.56 points. At the later follow-up, both groups showed a very small decrease from their end-of-intervention scores. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03666533 · results posted 10 June 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT03666533) looked at whether a type of mild electrical brain stimulation called tDCS (transcranial direct current stimulation) could influence walking ability in people who had experienced a stroke. Participants were split into two groups: one received active tDCS and the other received a "sham" (dummy) version that mimicked the procedure without delivering real stimulation. A total of 44 people started the trial — 21 in the active group and 23 in the sham group — and 40 completed it (19 and 21 respectively, with 2 people not completing in each group). The primary thing being measured was change in walking speed, tested by timing how long it took participants to walk 10 metres. The reported data shows the active tDCS group's walking speed increased by an average of 0.16 metres per second from their starting point, while the sham group's speed increased by an average of 0.12 metres per second. Several secondary measures were also reported. For the "Timed Up and Go" test — where a person stands from a chair, walks 3 metres, turns, and sits back down — the active group's time decreased by an average of 6.93 seconds and the sham group's by 5.7 seconds (a lower time indicates improved performance). Scores on a walking assessment under different conditions (Functional Gait Assessment, out of 30 points) increased by 2.79 points in the active group and 2.38 points in the sham group. For lower limb motor control (Fugl Meyer, out of 34 points), the active group's score increased by 2.26 points and the sham group's by 2.62 points. A measure of walking coordination (Gait Assessment and Intervention Tool, where lower scores are better) decreased by 2.42 points in the active group and 2.86 points in the sham group. Finally, a brain signal measurement looking at the balance of nerve activity between the stroke-affected and unaffected legs showed that 9 out of the active group and 8 out of the sham group had a reduction in imbalance between the two sides. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05767437 · results posted 23 May 2025

    According to the results reported on ClinicalTrials.gov, this trial involved 20 people in total, split into two groups of 10. It used a "crossover" design, meaning each group eventually received both treatments — one group did an abdominal drawing-in manoeuvre (ADIM) exercise first and then a sham (comparison) therapy, while the other group did it in the reverse order. It is worth noting that only 16 of the 20 participants completed the study — all 10 in the first group finished, while 4 people in the second group did not. The trial was measuring how each treatment related to the way participants moved their arm and trunk during a reaching task, looking at things like how far the trunk shifted, how the elbow bent, and how smoothly and quickly the arm moved. The reported data shows the following average figures for people across the whole study when comparing the ADIM exercise group to the sham therapy group. For trunk movement during reaching, the reported distances were 304.97 mm (ADIM) versus 303.34 mm (sham) — a very small numerical difference. The number of distinct movement bursts during the reaching task was reported as 4.30 for both groups. The elbow angle recorded was 127.43 degrees (ADIM) versus 134.13 degrees (sham). For the secondary measures, the total time to complete the reach was 3.25 seconds (ADIM) versus 3.06 seconds (sham). Peak hand speed was reported as 684.13 mm per second (ADIM) versus 934.48 mm per second (sham), and peak elbow angular speed — how fast the elbow was straightening — was 54.23 degrees per second (ADIM) versus 41.98 degrees per second (sham). The reported data presents these numbers as averages across participants, but no further statistical detail (such as whether the differences between groups were considered meaningful by the researchers) was included in the ClinicalTrials.gov submission, so that information cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05311384 · results posted 7 March 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT05311384) involved a single group of 10 participants who received what the researchers called the "Keys Intervention." Seven participants completed the study, while three did not finish. The trial was measuring changes in how people used an affected arm in everyday life, and how they felt about their own ability to carry out daily activities. Two questionnaire-style tools were used to track these changes at different points — before, during, and after the intervention. The reported data shows scores from two measuring tools. The first, called the Motor Activity Log (MAL), looks at how often and how well someone uses their affected arm across 30 everyday tasks, scored from 0 to 10 (where higher means more frequent use and better movement). Reported scores for how much the arm was used appeared to go from around 1.0–1.1 points at an early time point, up to around 3.5–4.0 points at later time points. Scores for quality of movement followed a similar pattern, moving from around 1.1 up to roughly 3.3–3.7 points across the different measurement stages. The second tool, the Canadian Occupational Performance Measure (COPM), asks people to rate their own performance and satisfaction with important daily activities, also on a 0–10 scale. The reported data shows performance scores moving from approximately 1.9 up to around 5.5, and satisfaction scores moving from around 1.3 up to approximately 4.7 across the measurement points. It is worth noting that because there was only one group and no comparison group, the data simply records scores at different points in time for the same participants. No statistical analysis results were included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05851573 · results posted 24 February 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT05851573) enrolled 11 participants, all of whom completed the study with no dropouts. The trial tested a psychosocial intervention — a type of support program addressing the emotional and mental wellbeing of participants — and measured changes in depression, anxiety, mood, stress, and related symptoms before and after the intervention. The reported data shows the following changes in scores from the start of the trial to the end. For depression, as measured by the Hospital Anxiety and Depression Scale (a questionnaire scored 0–21, where higher scores mean worse symptoms), the average score improved by 2.2 points. For anxiety on the same scale, the average score improved by 0.4 points. On a mood scale (scored 0–100, where higher means better mood), the reported change was −4.18 points, which according to the scale's scoring direction indicates a worsening in mood. On a depression questionnaire specifically designed for people with aphasia (a communication difficulty often following stroke), scored 0–30, the average improvement was a very small 0.10 points. A measure of anxiety-related behaviours (scored 0–30) showed an average improvement of 2.0 points, and a stress scale (scored 0–40) showed an average improvement of 3.36 points. It is worth noting that this was a very small study with only 11 participants and no comparison group, which means the reported numbers reflect a limited snapshot. The reported data shows changes in scores, but does not on its own tell us how meaningful those changes are in everyday life. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03001713 · results posted 11 February 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT03001713) involved 18,578 people across two groups. Around 11,159 people were in the intervention group, which received the program straight away, and 7,419 people were in the control group, which had a delayed start. The trial was measuring changes in two estimates of cardiovascular disease (CVD) risk — that is, the calculated chance of developing heart or blood vessel disease — over one year. The reported data shows two main measurements. The first was the change in a person's estimated 10-year CVD risk (a calculation of how likely someone might be to experience a heart or blood vessel event over the next 10 years). After one year, the intervention group's estimated 10-year CVD risk changed by +0.4 percentage points, while the control group's changed by +0.2 percentage points. The second measurement looked at something called "reversible CVD risk" — an estimate of how much CVD risk could potentially be reduced if certain health indicators reached recommended levels. For this measure, the intervention group's reversible risk changed by +0.4 percentage points, while the control group's changed by −0.1 percentage points (a negative number here represents a favourable direction, meaning estimated reducible risk went down slightly in the control group). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02398656 · results posted 31 January 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT02398656) enrolled 637 participants in each of two groups — one group received a clot-dissolving drug called tenecteplase (tNK), and the other received antiplatelet agents (medicines commonly used to help prevent blood clots from forming or growing). The trial was measuring how well participants recovered from their stroke symptoms by 90 days, using a standard scale called the modified Rankin Scale (mRS), which runs from 0 (no symptoms) to 6 (death), where lower scores mean better outcomes. Not all participants completed the study — 454 in the tenecteplase group and 432 in the antiplatelet group reached the end. The reported data shows that for the primary outcome — returning to their pre-stroke level of functioning by 90 days — 309 out of 637 participants in the tenecteplase group and 338 out of 637 in the antiplatelet group met this goal. For the secondary outcome — achieving a score of 0 or 1 on the mRS at 90 days (meaning little to no remaining symptoms) — the reported data shows 298 participants in the tenecteplase group and 321 in the antiplatelet group reached this result. These figures describe the raw numbers of people who reached each measured result; no further breakdown of this data was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03473223 · results posted 14 January 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT03473223) enrolled just over 18,000 people in total — approximately 9,114 in the CSL112 group and 9,112 in the placebo group. The trial was measuring whether CSL112 (compared to a placebo, an inactive dummy treatment) made a difference to the number of people who experienced a major cardiovascular event — specifically cardiovascular death, heart attack (myocardial infarction), or stroke — after a recent heart attack. These three events together were called MACE (Major Adverse Cardiovascular Events). The reported data shows that for the primary measure — the first time any of those three serious events occurred — 439 participants in the CSL112 group and 472 participants in the placebo group experienced such an event. For the secondary measures, the reported data shows: total hospitalisations related to blockages in heart, brain, or leg blood vessels were 433 (CSL112) versus 442 (placebo); cardiovascular deaths occurred in 107 (CSL112) versus 128 (placebo) participants; first heart attacks were recorded in 312 (CSL112) versus 342 (placebo) participants; and two broader measures of first cardiovascular death, heart attack, or stroke recorded 622 versus 683 participants, and 885 versus 944 participants respectively, across the different timeframes or definitions used. The breakdown of individual hospitalisation categories showed 367 versus 376 for coronary-related, 39 versus 36 for brain-related, and 27 versus 30 for leg-related hospitalisations. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05535257 · results posted 9 January 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants, all of whom completed the study with no dropouts. The trial looked at using a Sequential Compression Device (SCD) — a type of inflatable sleeve that gently squeezes the arm in a rhythmic pattern — on the upper arm and forearm. The study was measuring whether people could tolerate wearing the sleeve, whether it caused any pain, and a number of other observations including arm colour, swelling, arm strength, and sensation. The reported data shows that all 20 participants answered "yes" when asked whether they were tolerating the sleeve, and all 20 participants reported no pain when rating their discomfort on a pain scale (where they marked a point on a line between "no pain" and "worst possible pain"). For nail bed colour — a check of blood circulation by looking at the fingertips — all 20 participants were recorded as having a normal colour, with none recorded as dusky or bluish. Regarding arm swelling (measured in inches around the forearm), the reported data lists the number of participants at each measurement value, though specific measurement figures were not fully reported in a way that allows a clear summary. For arm strength, participants were spread across the rating scale used, with 8 out of 20 falling into the category of "no effort against gravity; limb falls." For arm sensation, the reported data shows 10 participants were recorded as having intact sensation and 10 as having impaired sensation. It is worth noting that this was a small study with only one group — there was no comparison group — so the numbers reflect observations from those 20 participants only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04302493 · results posted 20 December 2024

    According to the results reported on ClinicalTrials.gov, this trial involved 30 stroke survivors who were split into two groups: 16 people took part in a Mindfulness Based Stress Reduction (MBSR) programme, and 14 took part in a Stroke Support Group (SSG). By the end of the study, 14 people in the MBSR group and all 14 in the SSG group had completed the trial. The trial was measuring four things: thinking and memory ability, brain activity patterns, quality of life, and symptoms of depression — all assessed at one month and six months into the study. The reported data shows the following numbers across the two time points. For thinking and memory (scored 0–30, with scores below 26 considered below the normal range), the MBSR group scored 23.5 at one month and 25.5 at six months; the SSG group scored 22.5 at one month and 23.7 at six months. For brain activity — specifically a measure of how connected certain brain regions were during rest — the MBSR group recorded 1.99 connections at one month and 2.19 at six months, while the SSG group recorded 0 at both time points. For quality of life (scored 1–7, where 7 means better quality of life), the MBSR group scored 5.7 at one month and 5.2 at six months; the SSG group scored 6.1 at one month and 5.1 at six months. For depression symptoms (scored 0–27, where scores of 5–9 suggest mild depression and higher scores suggest more severe depression), the MBSR group scored 6.7 at one month and 6.1 at six months; the SSG group scored 5.2 at one month and 4.9 at six months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05643573 · results posted 9 December 2024

    According to the results reported on ClinicalTrials.gov, this trial compared two blood-thinning medicines — asundexian (a newer investigational drug) and apixaban (an already-approved medicine) — in people with an irregular heart rhythm called atrial fibrillation, which can raise the risk of stroke. The trial enrolled 7,383 people in the asundexian group and 7,374 in the apixaban group, making it a large study. The main things being measured were: how many people experienced a stroke or a clot travelling to another part of the body (called systemic embolism), how many experienced a serious bleeding event, and how many experienced a combination of those events. The reported data shows that when it came to stroke or systemic embolism, 98 participants in the asundexian group experienced one of these events, compared with 26 in the apixaban group. For serious (major) bleeding events, the reported numbers were lower in the asundexian group (17 participants) than in the apixaban group (53 participants). When stroke, systemic embolism, and serious bleeding were counted together, 120 participants in the asundexian group and 75 in the apixaban group experienced at least one of these events. Looking at secondary outcomes, ischemic stroke (a stroke caused by a blockage) occurred in 85 people taking asundexian versus 21 taking apixaban. Deaths from any cause were reported in 60 participants on asundexian and 71 on apixaban. The reported data shows that the trial was measuring these numbers to compare how the two medicines performed across these specific events, not to draw a conclusion about one being better overall. The combination outcome figures — more strokes but fewer bleeds with asundexian — reflect the trade-offs the trial was designed to examine. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04882215 · results posted 14 November 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04882215) looked at a working memory training programme and enrolled 14 participants into the Adaptive Training group. No participants were recorded in the Non-Adaptive Training group. The trial was primarily a feasibility study — meaning it was designed to find out whether running a larger trial would be practical — by tracking things like how easy it was to recruit people, how many dropped out, and how well participants stuck to the programme. It also gathered participants' feedback on the experience. The reported data shows that about 33% of people referred from the NHS who were eligible actually entered the intervention. Of those who started, approximately 36% dropped out before finishing. Among those who did take part, an average of around 74% of the eight training sessions were completed. Participants filled in a feedback questionnaire rated on a scale of 1 to 5, where 1 was the most positive score — the average score reported was 1.25, meaning responses were generally towards the positive end of that scale. For the secondary outcomes, which looked at memory task performance after the intervention, the reported data shows participants answered correctly on about 69% of trials in one memory task and about 78% of trials in another. It is worth noting that no figures were reported for the Non-Adaptive Training group for any of these outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04571099 · results posted 2 October 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 28 participants in total, divided into three groups based on their type of stroke: 3 people had an ischaemic stroke (a blockage-type stroke) and did not receive a clot-removal procedure, 22 people had an ischaemic stroke and did receive a clot-removal procedure, and 3 people had a haemorrhagic stroke (a bleeding-type stroke). All 28 participants who started the study completed it. The trial was measuring how well a newer type of brain imaging device — a dual-layer cone-beam CT (CBCT) scanner used in procedural suites — compared to standard CT scans in detecting and assessing strokes. The reported data shows the following figures for the main and additional measurements. For the primary outcome — how accurately the new device assessed the extent of ischaemic stroke compared to standard CT — a score of 90% agreement with the standard scan was reported for both the group that did not have a clot-removal procedure and the group that did. For one of the secondary outcomes, which looked at how well blood vessels were visible on the new device's images compared to standard CT angiography, the reported data shows that 77% of images from the clot-removal group were rated as showing vessel visibility that was no worse than the standard scan. For the other secondary outcome — detecting whether a brain bleed was present or not — the reported data shows 100% agreement with the standard CT scan in both the clot-removal group and the haemorrhagic stroke group. No figures were reported for the groups where data is not shown above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03263117 · results posted 5 September 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT03263117) enrolled 260 people in total — 130 in a **sedation** group and 130 in a **general anaesthesia** group. The trial was looking at two different ways of keeping stroke patients comfortable and still during a procedure to remove a blood clot from the brain (a mechanical thrombectomy). The main thing the researchers measured was participants' level of disability at the end of the study, using a standard disability scale called the modified Rankin Scale (mRS), which runs from 0 (no symptoms at all) to 6 (death). Of the 260 who started, 120 in each group completed the trial. The reported data shows the following breakdown of disability scores for the **general anaesthesia** group: 16 people scored 0 (no symptoms), 21 scored 1 (no significant disability), 20 scored 2 (slight disability), 21 scored 3 (moderate disability), 9 scored 4 (moderately severe disability), and 33 scored 5 or 6 (severe disability or death). For the **sedation** group: 11 scored 0, 23 scored 1, 13 scored 2, 24 scored 3, 16 scored 4, and 33 scored 5 or 6. When the scores were grouped into "good outcome" (scores 0–2, meaning broadly independent) versus "worse outcome" (scores 3–6), the reported data shows 57 participants in the general anaesthesia group and 47 in the sedation group fell into the good outcome category. The reported data also shows results for several secondary measures. On a stroke severity scale (NIHSS, scored 0–42 with higher meaning more severe), the median scores reported were 7 for the general anaesthesia group and 6 for the sedation group. For blood flow restoration during the procedure, 118 out of 120 participants in the general anaesthesia group and 116 out of 120 in the sedation group achieved a satisfactory flow result. Quality of life, measured on a scale where 1 is the best possible health state, was reported as 0.47 for the general anaesthesia group and 0.46 for the sedation group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04387162 · results posted 27 August 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04387162) enrolled five people in total — three in an "Immediate" group and two in a "Delayed" group. The trial was looking at a treatment called Prism Adaptation Treatment, which involves wearing special glasses (prisms) as a way of addressing a condition called spatial neglect — a difficulty noticing things on one side of the body or environment, which can occur after a stroke or brain injury. The study used several questionnaires and assessment tools to measure things like participant satisfaction, daily living activities, overall independence, and the severity of spatial neglect. The reported data shows the following scores across the groups. For satisfaction with the treatment (scored 8–32, higher meaning more satisfied), the Immediate group averaged 32 and the Delayed group averaged 27. For how believable and logical participants found the treatment (scored 1–9), the Immediate group averaged 6.2 and the Delayed group averaged 8.0; on the related expectation-of-improvement scale (0–100%), the Immediate group averaged 56.7% and the Delayed group averaged 75.0%. For daily living activities (scored 0–100, higher meaning more independent), both groups showed scores in the 70–87 range across different time points. For overall cognitive and motor independence (scored 18–126, higher meaning more independent), scores ranged roughly from 88 to 100 across both groups and time points. For the two spatial neglect measures — one where a lower score means more severe neglect (scored 0–146) and one where a higher score means more severe neglect (scored 0–30) — both groups showed scores that shifted across measurement time points, with the reported figures ranging from approximately 115 to 128 on the first scale and from about 1.5 to 3.6 on the second scale. No data was reported for variability or statistical comparisons, likely due to the very small number of participants. It is worth noting that with only five participants, this appears to have been a very small, early-stage study. The reported data shows what was measured and the average scores recorded, but no conclusions about whether the treatment does or does not work can be drawn from numbers alone, particularly from such a small group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03876457 · results posted 15 March 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT03876457) enrolled 352 people who had experienced a serious stroke. Participants were divided into two groups: 178 people received a procedure called endovascular thrombectomy (a technique to physically remove a blood clot from a brain artery) combined with standard medical management, while 174 people received standard medical management alone. The trial's main focus was measuring the level of disability or dependence participants experienced after their stroke, using a standard stroke recovery scale called the modified Rankin Scale (mRS), which runs from 0 (no symptoms) to 6 (death). The reported data shows that for the primary outcome — overall level of disability at follow-up — the median mRS score (that is, the middle value across the group) was 4 for the thrombectomy-plus-medical-management group and 5 for the medical-management-only group. On the secondary outcomes at 90 days: 36 out of 178 participants in the thrombectomy group scored 0–2 on the mRS (meaning they could largely look after themselves), compared with 12 out of 174 in the medical-management group. For being able to walk without assistance (mRS score of 0–3), 67 participants in the thrombectomy group reached this level, versus 32 in the medical-management group. Deaths within 90 days were reported as 68 in the thrombectomy group and 71 in the medical-management group. The reported data also shows that 44 people in the thrombectomy group and 27 in the medical-management group experienced a worsening of their neurological symptoms during the study period. Bleeding in the brain (symptomatic intracranial haemorrhage) was recorded in 1 participant in the thrombectomy group and 2 in the medical-management group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03935425 · results posted 12 March 2024

    According to the results reported on ClinicalTrials.gov, this trial involved 50 people in total, split evenly into two groups of 25 — one group used "FitMi Plus" and the other used "FitMi Basic." Both are versions of a home-based device designed to support arm and hand movement after stroke or similar conditions. The trial was measuring changes in how well participants could use their affected arm in everyday activities, as well as changes in the physical capability of that arm. Of the 50 who started, 48 completed the study — one person in each group did not finish. The reported data shows that both groups were measured using two different scales. For the primary measure — a self-reported scale (scored 0 to 5) rating how much and how well people used their affected arm in daily tasks — the FitMi Plus group showed an average change of 0.60 points (quality of movement) and 0.64 points (amount of use), while the FitMi Basic group showed average changes of 0.40 and 0.44 points respectively. For the secondary measure — a standardised assessment of arm physical ability scored out of 66 — the FitMi Plus group showed an average change of 2.0 points, and the FitMi Basic group showed an average change of 1.0 point. In both cases, a higher number indicates movement in a favourable direction on the scale. It is important to note that these figures simply describe the changes observed and reported during the trial period. The reported data does not tell us, on its own, whether any differences between the two groups are meaningful or due to chance, and no safety data was included in the structured results submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04550039 · results posted 1 March 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04550039) enrolled 14 participants in total — 7 in a group that used a body-weight-supported treadmill for walking training, and 7 in a group that used a powered robotic exoskeleton called the EksoNR. Five participants in each group completed the trial, with two in each group not finishing. The trial was designed to measure changes in "lateropulsion" — a condition where a person pushes or leans strongly to one side after a stroke, making balance and walking difficult. It used a range of standardised tests to track changes in pushing behaviour, walking speed, walking distance, and balance over the course of the training. The reported data shows that, on the two main (primary) outcome tests for pushing behaviour, both groups showed reductions in their scores over the trial period (a lower score meaning less pushing behaviour). On the Scale for Contraversive Pushing, the treadmill group's scores reduced by about 47% on average, while the exoskeleton group's scores reduced by about 60%. On the Burke Lateropulsion Scale, the treadmill group's scores reduced by about 68% on average, and the exoskeleton group's by about 54%. For the secondary outcomes, the reported data shows both groups recorded increases across walking speed, walking distance, and balance tests. For example, walking speed (10 Metre Walk Test) increased by around 143% in the treadmill group and around 220% in the exoskeleton group. Walking distance over six minutes increased by roughly 268% and 261% respectively. Balance scores (Berg Balance Scale) increased by around 73% in the treadmill group and around 372% in the exoskeleton group. Sitting balance scores increased by roughly 71% and 58% respectively. It is worth noting that this was a very small trial — only five people completed each group — so the reported numbers reflect a limited number of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04363944 · results posted 23 January 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04363944) looked at a smartphone-based home rehabilitation program called mRehab, designed for people working on upper limb (arm and hand) movement. A total of 19 people were enrolled — 18 in the main group using mRehab at home, and 1 in a separate group who completed all activities using both arms. Of those, 16 people in the main group and the 1 person in the other group finished the study. The trial measured things like how many repetitions of each exercise participants completed, how long each activity took, and how smoothly they moved, as well as some standard hand and arm function tests. The reported data shows that, in the main group, the average number of repetitions completed per activity over the six-week program ranged from around 153 to 292, depending on the activity. Average time to finish each activity ranged from about 4 seconds up to roughly 22 seconds in the main group, and up to about 26 seconds for the single participant in the bilateral (both arms) group. Movement smoothness was measured using a "jerk score" — where a lower number means smoother movement — and the main group's scores ranged from roughly 331 to 493 across different activities, while the bilateral participant's scores were generally higher (ranging from about 347 to 1,870). For the standard arm function test (Wolf Motor Function Test), the main group averaged about 15 seconds per task, compared to 96 seconds for the bilateral participant. On the Nine Hole Peg Test — a finger dexterity task — the main group averaged about 136 seconds, while the bilateral participant was recorded at the maximum score of 300 seconds, meaning the task was not completed within the allowed time. For ease of use of the 3D-printed objects used in the program, the main group reported an average rating of 1.07 out of a possible 3 (where 3 means "very easy to use"). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03578536 · results posted 16 January 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT03578536) involved a very small group of participants — three people in total — who took part in a programme called "CIT With Recovery Rapids." CIT stands for Constraint-Induced Therapy, a type of rehabilitation approach for the arm and hand after stroke. Two participants completed the trial and one did not. The trial was measuring upper limb movement and how well participants could use their affected arm in everyday activities. The reported data shows two scores for the Action Research Arm Test (ARAT), a 19-item assessment where a score of 0 means no movement and 57 means no impairment at all. The two scores reported were 37.5 and 47 out of 57 — it is not specified which time points these relate to. For the Motor Activity Log (MAL), which asks participants to rate how well they use their more affected arm in daily tasks on a scale of 0 to 5, the reported data shows a change score of 2.7 — this represents the difference between the score at the start and at the end of the programme. For the third measure, the Wolf Motor Function Test (a timed test of arm and hand movements), no data was reported. It is worth noting that with only three participants, this was a very small study, and the reported numbers reflect only those individuals. The reported data shows what was measured in this particular group; it does not tell us how these results compare to a group that did not receive the programme. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05330234 · results posted 11 January 2024

    According to the results reported on ClinicalTrials.gov, this trial involved 10 therapists (not patients) who tested a system across three phases. The trial was measuring how usable and satisfying the therapists found the system, using two standard questionnaires designed to capture people's subjective experience of using a technology or software tool. Four of the 10 therapists did not complete all phases — 9 continued into Phase 2 and 6 completed Phase 3. The reported data shows that usability was measured using the System Usability Scale (SUS), a 0–100 questionnaire where a higher number suggests greater perceived usability. Therapists scored the system 73.3 out of 100 in Phase 1, 78.3 out of 100 in Phase 2, and 77.1 out of 100 in Phase 3. A secondary measure — the Post-Study System Usability Questionnaire (PSSUQ) — was completed at the end of Phase 3 by the 6 remaining therapists. This questionnaire uses a 1–7 scale where a *lower* score indicates greater perceived satisfaction. The reported data shows an overall average score of 2.6, with sub-scores of 2.5 for system usefulness, 2.7 for information quality, and 2.6 for interface quality. It is worth noting that this trial measured therapists' perceptions of a system's usability only — it did not measure patient health outcomes, and no patient participants were enrolled. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02864953 · results posted 9 January 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT02864953) enrolled 535 people who had experienced a stroke — 268 received a placebo (an inactive treatment) and 267 received the investigational drug BIIB093. The trial was primarily measuring how well participants were functioning 90 days after their stroke, using a standard stroke recovery scale called the modified Rankin Scale (mRS), which rates disability from no symptoms through to severe disability or death. A number of secondary measurements were also recorded, including brain imaging, survival data, and the occurrence of unwanted medical events. The reported data shows the following breakdown of where participants landed on the disability scale at Day 90. In the placebo group: about 1.4% had no disability, 2.8% had slight disability, 12.6% had moderate disability, 25.2% had moderate-to-severe disability, and 57.9% fell into the most severe category (including death). In the BIIB093 group, the figures were: 3.2%, 5.1%, 12.0%, 23.5%, and 56.2% respectively across those same categories. When looking at participants who scored in the less severe range of the scale (categories 0–4), 41.6% of the placebo group and 42.9% of the BIIB093 group reached that threshold. For the measure of brain midline shift (a marker of swelling pushing brain structures off-centre) at 72 hours, the placebo group averaged 6.32 millimetres and the BIIB093 group averaged 7.02 millimetres. Regarding survival time, the reported data shows that specific figures were not provided for either group. For unwanted medical events, 95.4% of placebo participants and 97.3% of BIIB093 participants reported at least one adverse event, while serious adverse events were reported in 68.3% and 76.8% of participants respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04778475 · results posted 18 December 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 100 people who had experienced a stroke — 50 in Group A and 50 in Group B. The trial was measuring changes in several areas during their hospital stay, including balance and posture, ability to carry out everyday activities, stroke symptom severity, and how long participants stayed in hospital. Of the 100 people who started, 96 completed the study — all 50 in Group B and 46 in Group A, with 4 people in Group A not completing the trial (the reasons were not detailed in the data provided here). The reported data shows the following results across the groups. For balance (measured on a scale of 0–36, where higher means better balance), Group A showed a change of +10.23 points compared with +5.78 for Group B. For everyday functioning (measured on a scale of 0–5, where lower means less difficulty), both groups showed a reduction in score — Group A by 1.70 points and Group B by 0.89 points. For basic mobility in hospital (measured on a scale of 6–24, where higher means better mobility), Group A showed a change of +4.65 points compared with +1.90 for Group B. Average hospital stay was reported as 5.0 days for Group A and 5.3 days for Group B. For the secondary outcomes, the reported data shows that stroke symptom severity (measured on a scale of 0–42, where lower means less severe) decreased by 4.79 points in Group A and 3.45 points in Group B. The overall average stroke symptom score across the study was reported as 7.6 for Group A and 5.9 for Group B. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04116112 · results posted 12 October 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT04116112) enrolled 120 people who had suffered a stroke, divided equally into three groups of 40. Each group was assigned a different blood pressure target during treatment: a higher blood pressure target, a moderately lower target (below 160 mmHg), or a more strictly lower target (below 140 mmHg). The trial was measuring two main things: the size of the damaged area in the brain (called an infarct) seen on a brain scan about 36 hours after treatment began, and participants' level of disability or dependence after their stroke, rated on a specially weighted scale from 0 (worst) to 1 (best). The reported data shows that the size of the damaged brain area differed across the three groups. The higher blood pressure target group had a reported average damaged area of 46.4 cubic centimetres, the moderately lower target group had 50.7 cubic centimetres, and the more strictly lower target group had 32.4 cubic centimetres. For the disability scale (where 1 is the best possible score), the reported scores were 0.58 for the higher target group, 0.47 for the moderately lower target group, and 0.51 for the strictly lower target group. For the secondary outcomes, the reported data shows that new bleeding within the damaged brain tissue was observed in 12 participants in each of the first two groups and 14 participants in the strictly lower target group. Bleeding that was also associated with a noticeable worsening of stroke symptoms was reported in 2, 1, and 2 participants across the three groups respectively. Notably, no participants in any group were reported to have experienced neurological worsening linked to blood pressure-lowering treatment. The compliance outcome data was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02996266 · results posted 21 September 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT02996266) enrolled 677 people who had experienced a stroke — 339 in a "Fever Prevention" group and 338 in a "Standard Care" group. The trial was measuring whether actively preventing fever in stroke patients made a difference compared to usual care. Not everyone completed the study: 211 people in the Fever Prevention group and 222 in the Standard Care group finished, with the remainder not completing for reasons the data does not detail. The primary thing being measured was "fever burden" — roughly, how much fever a person had over time, expressed in degrees Celsius multiplied by hours (a way of capturing both how high a temperature was and how long it lasted). The reported data shows the Fever Prevention group had an average fever burden of 0.37 °C-hours, compared to 0.73 °C-hours in the Standard Care group, suggesting the intervention did reduce fever burden as measured. For the secondary outcomes — which looked at things like neurological function, independence in daily activities, and thinking and memory — the reported data shows the scores were broadly similar between the two groups across all measures. On the disability scale (Modified Rankin Scale, where 0 means no symptoms and 6 means death), both groups averaged around 3.6–3.7. On the stroke severity scale, independence scale, brain injury recovery scale, and cognitive assessment, the numbers between groups were also close, with no large differences reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03766581 · results posted 12 June 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03766581) enrolled a total of 2,366 participants across eight groups. Most were assigned to one of six doses of a drug called milvexian or to a placebo (a dummy treatment with no active ingredient). The trial was measuring two main things over 90 days: first, how many participants had either a new stroke or a new "covert brain infarction" (a small, silent area of reduced blood flow in the brain detected by a brain scan but causing no obvious symptoms); and second, various types of bleeding events across the different dose groups. The reported data shows that for the primary outcome — the percentage of participants who had either a new stroke or a new silent brain lesion detected by MRI — the model-based estimates were: 16.8% in the placebo group, 16.7% in the milvexian 25 mg once-daily group, 16.6% in the 25 mg twice-daily group, 15.6% in the 50 mg twice-daily group, 15.4% in the 100 mg twice-daily group, and 15.3% in the 200 mg twice-daily group. For the secondary bleeding outcomes, the reported data shows that the percentage of participants who experienced major bleeding (as defined by a standard research scale called BARC Types 3 and 5) was 0.6% in the placebo group; 0.6% in the milvexian 25 mg once-daily group; 0.6% in the 25 mg twice-daily group; 1.5% in the 50 mg twice-daily group; 1.6% in the 100 mg twice-daily group; and 1.5% in the 200 mg twice-daily group. The two smaller dose groups (50 mg and 100 mg once daily) reported 0% major bleeding, though those groups were much smaller in size. The reported data also shows counts of any bleeding events using several different standard research definitions (ISTH, PLATO, and the full BARC scale), with numbers varying across dose groups and bleeding categories. Some figures within these secondary measures were not fully matched to all group labels in the submitted data, so a complete group-by-group breakdown for every bleeding sub-category cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03441334 · results posted 6 May 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03441334) was set up to compare two groups: one receiving high frequency repetitive transcranial magnetic stimulation (rTMS — a non-invasive brain stimulation technique) and one receiving a sham (inactive/pretend) version of the same procedure. The trial intended to measure walking speed, quality of life, motor (movement) function, brain activity levels, and walking endurance — primarily in people who had experienced a stroke. However, the reported data shows that only one person was enrolled in the entire study, placed in the high frequency rTMS group, and that person did not complete the trial. No one was enrolled in the sham group. Because of this, the reported data shows no outcome numbers at all for any of the measures — whether that is walking speed, quality of life scores, movement function, brain excitability, or walking endurance. None of these results were reported, most likely because the trial did not recruit enough participants to collect or analyse any meaningful data. The reasons for the trial not proceeding as planned are not explained in the submitted results. In short, while the trial had a clear plan for what it would measure and how, the reported data on ClinicalTrials.gov contains no findings — there is simply not enough information from this study to draw any conclusions about the procedures being tested. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04304508 · results posted 19 April 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT04304508) enrolled 1,808 people across four groups: those taking one of three doses of a medicine called asundexian (10 mg, 20 mg, or 50 mg) or a placebo (a dummy pill with no active ingredient). The trial was measuring how many participants experienced either a symptomatic ischaemic stroke (a stroke caused by a blood clot, with noticeable symptoms) or a "covert" brain infarct — a small area of brain damage picked up on MRI scans but without obvious symptoms. Around 1,291 people completed the study. The reported data shows that for the main (primary) outcome — the combined count of symptomatic ischaemic strokes and covert brain infarcts found on MRI — the numbers across groups were broadly similar. For symptomatic ischaemic strokes alone (one part of the primary measure), the reported figures were 24 participants in the 10 mg group, 25 in the 20 mg group, 17 in the 50 mg group, and 23 in the placebo group. For covert brain infarcts detected by MRI (the other part), the numbers were 56, 57, 56, and 55 respectively. Separately, when looking at symptomatic ischaemic strokes on their own as a secondary outcome, the reported counts were 26, 26, 22, and 28 across the four groups. For a broader secondary outcome that also included cardiovascular death, heart attack, and systemic embolism (a clot blocking a blood vessel elsewhere in the body), the counts were 33, 30, 33, and 35 participants across the groups. The reported data also shows that for the secondary outcome counting both ischaemic and bleeding strokes together, the figures were 26, 26, 25, and 30 participants in each group. Covert brain infarcts detected by MRI as a standalone secondary measure were reported as 62, 68, 63, and 60 participants respectively. No additional detail on some sub-components of the secondary outcomes was reported in the submitted data beyond participant counts. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT04962503 · results posted 11 April 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 6 people who had experienced a stroke, and all of them received the study treatment, SCENESSE® (afamelanotide 16mg). Five participants completed the trial, while one did not. The trial was measuring three things: changes in the size of the stroke-affected area in the brain (called an "infarct"), changes in neurological function (how well the brain and nervous system were working), and changes in participants' ability to carry out daily activities. The reported data shows that the volume of the stroke-affected area in the brain was measured at two points — the reported values were 9.97 mL and 4.06 mL (millilitres is a way of measuring the size of the affected area). For neurological function, participants were assessed using a stroke scale that runs from 0 (no stroke symptoms) to 42 (most severe). The reported data shows an average change of minus 4.5 points on that scale, meaning scores moved in the lower direction on average. For daily activities, participants were rated on a disability scale from 0 (no symptoms) to 6 (death). The reported data shows the number of participants at various points on that scale, with counts of 4, 1, 1, 3, 2, and 1 participants recorded across the different score categories, though the specific score each count corresponds to was not clearly labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT04149535 · results posted 2 February 2023

    According to the results reported on ClinicalTrials.gov, this trial involved 3,000 people who were having a heart valve procedure called TAVR (a minimally invasive way of replacing a narrowed heart valve). Participants were split into two groups: 1,501 people had the TAVR procedure using a device called the Sentinel, which is designed to capture debris that can be dislodged during the procedure, and 1,499 people had TAVR without the Sentinel device. The main thing the trial was measuring was whether participants experienced a stroke within 72 hours after the procedure, or before leaving hospital if that happened sooner. The reported data shows that, in the group who had the Sentinel device used during their procedure, 34 out of 1,501 participants experienced a stroke within that timeframe. In the group who did not have the Sentinel device, 43 out of 1,499 participants experienced a stroke in the same period. These numbers cover all types of stroke that were recorded and assessed by an independent medical review committee. No other outcome measures were included in the data provided, so only these figures can be described here. If additional outcomes were measured, those results were not reported in the data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT04640519 · results posted 3 October 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT04640519) involved 50 people in total, split evenly into two groups of 25 — one group received something called the TASC Intervention, and the other was a control group (meaning they did not receive the intervention). All 50 participants completed the study. The trial was looking at blood pressure management after hospital discharge, specifically measuring how many people achieved a systolic blood pressure (the "top number" in a blood pressure reading) below 130 mmHg over three months of remote monitoring. It also looked at whether participants completed video visits with their care team, and whether they reported taking their blood pressure medications as directed. The reported data shows that, for the main measure of blood pressure control, 76% of participants in the TASC Intervention group reached the target blood pressure level, compared with 25% in the control group. For the second main measure — whether participants completed at least one video visit with their care team — 91% of the intervention group did so, compared with 75% of the control group. For the secondary measure of medication adherence (how consistently participants reported taking their blood pressure tablets), the reported data shows 67% of the intervention group and 63% of the control group were recorded as adherent. It is worth noting that this was a small study of 50 people, and the results simply describe what was counted and measured in these two groups during the trial period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT03728153 · results posted 25 May 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT03728153) enrolled 34 participants, all of whom received a 20mg dose of the treatment being studied. Of those, 32 completed the trial and 2 did not finish. The trial was measuring several things in stroke patients: levels of sodium in the blood, levels of a liver enzyme called ALT (a marker sometimes used to check on liver health), motor function (movement ability), disability level, and symptoms of depression. The reported data shows that the average blood sodium level across participants was 138.7 mmol/L (a level below 125 mmol/L was used as the threshold of concern in this trial). The average ALT liver enzyme level was reported as 28 U/L (a level above 120 U/L was used as the threshold of concern). For movement ability after stroke, the reported average score on the Fugl-Meyer Motor Scale — which runs from 0 (greatest difficulty) to 100 (least difficulty) — was 62.7. On the Modified Rankin Scale, which measures disability on a range from 0 (no symptoms) to 6 (death), the average reported score was 2. Depression symptoms were measured using two questionnaires: the Montgomery-Åsberg Depression Rating Scale (scored 0–60, with higher meaning more severe) returned an average of 5.6, and the PHQ-9 (scored 0–27, with higher meaning more severe) returned an average of 4.6. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT02905032 · results posted 25 January 2022

    According to the results reported on ClinicalTrials.gov, this trial involved three groups: 467 patients who received standard care, 475 patients who received standard care plus a decision aid tool, and 244 clinicians. The trial was looking at how a decision aid — a tool designed to support conversations between patients and doctors about blood-thinning medication (anticoagulants) — affected the decision-making process. Most participants completed the study, with small numbers of patients (8 in the standard care group and 12 in the decision aid group) not finishing. The reported data shows that when it came to clinicians feeling satisfied with how the medication discussion went, 277 encounters in the standard care group and 400 encounters in the decision aid group were rated as satisfying (a score of 4 or 5 out of 5). For clinician recommendations — whether the doctor would recommend their approach to colleagues — 199 encounters in the standard care group and 396 in the decision aid group received a high rating (6 or 7 out of 7). For the secondary measures, the reported data shows that 391 participants in standard care and 399 in the decision aid group chose to start or continue blood-thinning medication. Patient involvement in decision-making, measured by trained observers on a scale of 0 to 100, scored 29.1 for standard care and 33.0 for the decision aid group. The average length of the appointment was 31 minutes for standard care and 32 minutes for the decision aid group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT04834362 · results posted 6 December 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 105 people in total — 53 in the analog insulin group and 52 in the human insulin group. Most participants completed the study (52 and 50 respectively, with just one and two people not finishing in each group). The trial was comparing two types of insulin — analog insulin and human insulin — in a hospital setting, with the main focus on blood glucose (sugar) levels, and secondary measurements including daily insulin doses used, how long people stayed in hospital, and how many people died while in hospital. The reported data shows that average blood glucose levels were 10.7 mmol/L in the analog insulin group and 10.9 mmol/L in the human insulin group. For daily insulin use, the analog insulin group used an average of 22.3 units per day compared to 26.7 units per day in the human insulin group. The reported data shows that average length of hospital stay was very similar between the two groups — 4.7 days for the analog insulin group and 4.8 days for the human insulin group. Regarding in-hospital deaths, 15 participants in the analog insulin group and 16 participants in the human insulin group died during their hospital stay; no further details about these figures were provided in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT03615079 · results posted 10 November 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 28 people who were given access to a Cognitive Behavioural Therapy (CBT) program — a structured talking-based approach that helps people recognise and change unhelpful thought patterns. The trial was measuring two things: changes in depression symptoms over 90 days, and participants' quality of life. Of the 28 people who started, 11 completed the trial and 17 did not finish. The reported data shows that the primary outcome — depression symptoms — was measured using a questionnaire called the PHQ-9, which runs from 0 (no symptoms) to 27 (severe symptoms), with scores above 10 generally considered a positive sign of depression. The results reported a figure of 6 for this measure, though the data as submitted does not separately show the starting score and the ending score — only a single value of 6 is listed. This means it is not possible from the submitted data alone to describe the full before-and-after comparison as the trial originally intended. For the secondary outcome, quality of life was measured using a questionnaire called the EuroQOL-5D, which runs from 1 to 100, where higher numbers indicate better quality of life. The reported data shows an average score of 73 on this scale, though again, no comparison score was reported. It is worth noting that fewer than half of the participants who started the trial completed it, which the reported data does not explain further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02737930 · results posted 13 October 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT02737930) enrolled 12 participants in total — 5 received fluoxetine (an antidepressant medication being investigated for a different purpose here) and 7 received a placebo (a dummy treatment). All 5 in the fluoxetine group and 6 of the 7 in the placebo group completed the study; one person in the placebo group did not finish. The trial was measuring changes in vision — specifically in the visual field (the full area a person can see) — in people who had lost part of their sight, likely following a stroke or similar event. The reported data shows that, for the main outcome measured — the percentage change in a summary score of visual field sensitivity — the fluoxetine group showed an average change of 64.4%, compared with 26.0% in the placebo group. For a secondary measure looking at the percentage of individual visual field points that showed meaningful recovery, the reported figures were 72.4% for the fluoxetine group and 32.1% for the placebo group. When counting participants who showed very substantial recovery (at least 95% reduction in their blind visual field), the reported data shows 3 out of 5 in the fluoxetine group and 1 out of 6 in the placebo group met this threshold. A questionnaire about how vision affects daily life (scored 0–100, with higher being better) showed a reported change of −11.2% in the fluoxetine group and −14.9% in the placebo group. A depression symptom score (where lower is better) changed by −1 point in the fluoxetine group and 0 points in the placebo group. Results for one secondary measure — a "functional field score" rating peripheral vision — were not reported in the submitted data. It is worth noting that this was a very small trial with only 12 participants, which means these numbers should be interpreted with considerable caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02666742 · results posted 24 September 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT02666742) enrolled 246 people in total, with 123 participants in each of two groups: one group received a Direct Oral Anticoagulant (DOAC, a type of blood-thinning medication) and the other received Aspirin. All 246 participants completed the study with no dropouts recorded. The trial was measuring the number of participants who experienced certain brain-related events — including mini-strokes (called transient ischaemic attacks, or TIAs, which are brief episodes of stroke-like symptoms that resolve on their own), full strokes, and silent brain events detected on MRI scans (changes picked up by brain imaging even though the person had no obvious symptoms) — as well as procedure-related complications. The reported data shows the following numbers for the primary outcomes: In the DOAC group, 6 participants were recorded as having a TIA, compared with 22 in the Aspirin group. For stroke, 0 participants in the DOAC group and 8 in the Aspirin group had this outcome recorded. For silent brain events detected on MRI at 24 hours after the procedure, 15 participants in the DOAC group and 28 in the Aspirin group were recorded with such events; at 30 days follow-up, those numbers were 8 in the DOAC group and 22 in the Aspirin group. The reported data for the secondary outcomes shows that 15 participants in the DOAC group and 17 in the Aspirin group experienced procedure-related complications (a combined measure covering a range of complications and in-hospital death). Cardiac tamponade — a serious condition where fluid builds up around the heart — was recorded in 4 participants in the DOAC group and 3 in the Aspirin group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT01573169 · results posted 10 September 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT01573169) enrolled 73 people who had experienced a stroke and were being treated in hospital. Participants were divided into two groups: 38 people received low molecular weight heparin (a type of blood-thinning injection) and 35 received what the trial called "standard therapy." The trial was looking at whether the type of blood-thinning treatment affected the rate of blood clots forming in the veins (either noticed because of symptoms or picked up silently on ultrasound), as well as tracking bleeding events, deaths, and levels of disability. The reported data shows that for the main thing being measured — the number of people who developed blood clots in their veins — 6 out of 38 participants in the low molecular weight heparin group and 7 out of 35 in the standard therapy group had this outcome recorded. For the additional measures, bleeding events (both inside and outside the brain) were recorded in 1 person in the heparin group and 3 people in the standard therapy group. Deaths from any cause were recorded for 7 people in the heparin group and 6 people in the standard therapy group. Regarding disability, measured on a scale where a score of 3 or higher indicates needing at least some help with daily life, 27 out of 38 people in the heparin group and 30 out of 35 in the standard therapy group fell into that category at the end of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03775915 · results posted 13 August 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT03775915) involved 24 people in total — 12 in a "real neurofeedback" group and 12 in a "sham (pretend) neurofeedback" group. All 24 participants completed the study with no dropouts. The trial was measuring two main things: brain activity patterns during movement of an affected hand (using a brain scan called an fMRI, which tracks blood flow as a marker of activity), and how well participants could use their hand on a practical task called the Jebsen Taylor Hand Function Test, which times how long it takes to complete everyday activities. The reported data shows that for brain activity, a score called the "laterality index" was used — a positive number means more activity on the side of the brain closer to the injury, which was the focus of measurement. Across several time points, the real neurofeedback group's scores ranged from 0.23 to 0.26, while the sham group's ranged from 0.22 to 0.30. For the hand function test, lower times (in seconds) mean the tasks were completed more quickly. The real neurofeedback group's times went from 267 seconds at the start down to 214 seconds at the last reported time point; the sham group went from 274 seconds down to 249 seconds. For a secondary measure of upper limb function (scored 0–57, where higher is better), the real neurofeedback group went from 31.9 to 34.3, and the sham group went from 35.3 to 35.8. Some secondary outcomes — including EEG-based brain activity and one brain activity change measure — had no data reported. The reported data for a squeeze-task brain scan showed laterality index values of 0.31 (real) and 0.21 (sham) at one time point, and 0.29 (real) and 0.28 (sham) at another. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03215771 · results posted 14 July 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT03215771) enrolled 16 participants in total — 8 who had experienced a stroke and 8 who had experienced a traumatic brain injury (TBI). All participants used a device called the MyoPro (a motorised arm brace) combined with a type of movement-based training. Thirteen of the 16 participants completed the trial, while 3 did not finish. The trial was measuring changes in arm movement, muscle stiffness, ability to carry out everyday tasks, satisfaction with the device, and participation in daily life. The reported data shows the following results for the one group of participants. For arm movement ability, measured on the Fugl-Meyer scale (where a higher score out of 66 means less impairment), the reported change was 7.5 points. For muscle stiffness (measured on the Modified Ashworth Scale, where a lower score means less resistance when a limb is moved), the reported change was −2.3 points. For everyday task performance, measured on the Chedoke Arm and Hand Activity Inventory (scored from 13 to 91, with higher being better), the reported change was 8.8 points. Satisfaction with the device, measured on an 11-to-55-point survey, was reported as an average score of 26.7. Participation in daily life, measured on the CHART survey (scored from 0 to 500, with higher being better), showed a reported change of 34.9 points. Because there was only one group in this trial and no comparison group, these figures represent changes from the start of the trial only. It is worth noting that the reported data does not include the starting (baseline) scores for each measure, so it is not possible from these figures alone to say where participants began or ended up on each scale — only how much the scores are said to have changed. No comparison was made against a control or placebo group, and the trial was relatively small. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03592745 · results posted 29 June 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people in total — 18 in each group. One group received active transcutaneous vagus nerve stimulation (tVNS, a type of mild nerve stimulation applied to the skin) combined with robotic arm therapy, while the other group received a sham (inactive/dummy) version of the stimulation combined with the same robotic arm therapy. The trial was measuring changes in arm muscle activity and arm function in people undergoing rehabilitation. Fifteen participants in each group completed the study, with three in each group not finishing. The reported data shows that the main thing being measured was the change in muscle activity in the bicep and tricep muscles during arm movements, expressed as a percentage of each person's maximum muscle effort. For the active stimulation group, the reported median change in muscle activity was 22.31% immediately after the three-week program and 16.07% at a follow-up around three months later. For the sham group, the reported figures were 7.01% immediately after and 10.055% at follow-up. The trial also looked at scores on a standard arm function assessment (the Upper Extremity Fugl-Meyer scale, which runs from 0 to 66, with higher numbers indicating better function). The reported data shows a median change of 2.00 points for the active stimulation group and 2.50 points for the sham group at three weeks, and 2.33 points versus 1.67 points respectively at the three-month follow-up. No other outcome figures were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT03763929 · results posted 18 June 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT03763929) looked at a drug called Trans Sodium Crocetinate compared to a placebo (an inactive treatment) in people who had experienced a stroke. The trial measured participants' level of disability after their stroke using a standard scale called the Modified Rankin Scale (mRS). This scale runs from 0 (no symptoms at all) to 6 (death), with lower numbers meaning less disability. In total, just 6 people took part — 2 in the Trans Sodium Crocetinate group and 4 in the placebo group — and all 6 completed the trial. The reported data shows that the average mRS score for the 2 participants who received Trans Sodium Crocetinate was 2.5, which sits between "slight disability" and "moderate disability" on the scale. For the 4 participants who received the placebo, the average reported score was 3.0, which corresponds roughly to "moderate disability." No other outcome measures were reported in the submitted results data. It is important to note that with only 6 participants in total, this was an extremely small group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT03338998 · results posted 7 June 2021

    According to the results reported on ClinicalTrials.gov, this trial looked at a drug called BAF312 compared to a placebo (an inactive treatment) in people who had experienced a type of brain bleed called an intracerebral haemorrhage. A total of 29 people took part — 16 received BAF312 and 13 received placebo. The main thing the trial was measuring was the volume of swelling around the blood clot in the brain (called perihematoma oedema), which was tracked using CT scans taken at several time points over the first two weeks after the bleed. The reported data shows that at the key measurement point, the average volume of brain swelling around the clot was 55.09 millilitres in the BAF312 group and 52.50 millilitres in the placebo group. The trial also measured the levels of BAF312 in participants' blood at different time points. The reported data shows those blood concentration levels ranged from a low of approximately 0.17 ng/mL (nanograms per millilitre, a very small unit of measurement) at one time point, rising to a peak of around 81.94 ng/mL, and then falling back to approximately 36.45 ng/mL at the last recorded time point. No blood concentration data was reported for the placebo group, which is expected as they did not receive the active drug. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT03600376 · results posted 26 April 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT03600376) enrolled 17 people in total — 9 in the group that received Ryanodex alongside standard care, and 8 in the group that received standard care only. The trial was measuring how many participants regained consciousness, defined as reaching a score of 13 or higher on the Glasgow Coma Scale (GCS) — a standard tool where doctors assess eye opening, speech, and movement, with scores ranging from 3, meaning no response, up to 15, meaning fully alert. The main focus was on whether this level of consciousness was reached within 90 minutes of joining the trial. The reported data shows that for the primary measurement — consciousness recovery within 90 minutes — 4 out of 9 participants in the Ryanodex plus standard care group reached a GCS score of 13 or above, compared with 2 out of 8 participants in the standard care only group. The secondary outcome tracked the same measure of consciousness recovery across the full duration of the study. The reported data shows the numbers gradually building over time, with the Ryanodex plus standard care group reaching a cumulative count of 4 participants and the standard care only group reaching a cumulative count of 2 participants by the end of the study period. It is worth noting that a number of participants did not complete the trial — 2 in the Ryanodex group and 6 in the standard care only group — and the reasons for this were not detailed in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02048826 · results posted 25 March 2021

    According to the results reported on ClinicalTrials.gov, this trial involved 31 people in total — 16 in a group called FINGER I and 15 in a group called FINGER II. Almost all participants completed the trial (15 from FINGER I and all 15 from FINGER II), with only one person from FINGER I not completing it. The trial was measuring changes in arm and hand function, looking at how well participants could move and use their hands and arms before and after a period of therapy. The reported data shows that for the main measurement — a test called the Box and Block Test, which counts how many blocks a person can pick up and move in 60 seconds — the average change in score from the start of the trial to one month after therapy was 2.3 blocks for the FINGER I group and 2.4 blocks for the FINGER II group. The reported data also shows results from two additional measurements. On a 57-point arm function test (called the Action Research Arm Test), the average score change was 2.5 points for FINGER I and 3.5 points for FINGER II. On a third test measuring arm and hand movement on a scale of 0 to 66 (the Fugl-Meyer test), the average score change was 3.7 points for FINGER I and 1.8 points for FINGER II. In all three tests, a higher score indicates better arm and hand function. It is worth noting that these figures represent average changes within each group, and the trial involved a relatively small number of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03436810 · results posted 25 March 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT03436810) enrolled 40 people in total — 20 in an experimental group and 20 in a control group. All 40 participants completed the study with no drop-outs. The trial measured changes in the way people walk (their "gait") over a 4-week period, looking at things like walking speed, the length of each step, how long each step took, how many steps were taken per minute (cadence), how far people could walk in 6 minutes, and how many steps they could complete in a step test. The reported data shows the following numbers at 4 weeks: for walking speed, the experimental group recorded 0.78 metres per second compared with 0.58 metres per second in the control group. For step length, the reported figures show two sets of measurements — 49.76 cm and 47.78 cm for the experimental group, and 42.07 cm and 41.45 cm for the control group (the data does not explain why two figures appear for each group). For step time, the experimental group recorded 0.72 seconds and 0.53 seconds across two measurements, while the control group recorded 0.83 seconds and 0.70 seconds. Cadence was reported as 94.13 steps per minute for the experimental group and 78.88 for the control group. In the 6-minute walk test, the experimental group recorded a change score of 246.50 metres compared with 152.50 metres for the control group. Finally, the step test showed a change of 12.60 steps for the experimental group and 10.65 steps for the control group. It is worth noting that the submitted data does not include starting (baseline) values or explain the duplicate step-length and step-time figures, so the full picture of what changed from before to after treatment is not reported in a way that can be clearly described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT02665052 · results posted 17 March 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT02665052) looked at a type of arm exercise training called BATRAC (Bilateral Arm Training with Rhythmic Auditory Cueing) for people who had experienced a stroke. A total of 48 participants were enrolled across four groups: 11 people did home-based BATRAC, 9 did a lab-based version of BATRAC combined with another therapy called TTT, 9 received usual care (as a comparison group), and 19 were caregivers taking part in a separate arm of the study. By the end of the trial, 8, 7, 9, and 14 people respectively had completed their assigned group. The reported data shows three outcome measures recorded after around six weeks. The main thing being measured was how quickly participants could complete a set of arm movement tasks (called the Wolf Motor Function Test, or WMFT) — a lower score means faster movement. The reported average scores (on a mathematical scale used to smooth out extreme values) were 3.6 for the home-based group, 2.9 for the lab-based group, and 3.1 for the usual care group. For arm movement ability more broadly (measured on the Fugl-Meyer scale, where higher scores out of 66 are better), the reported averages were 32.3, 40.7, and 32.0 for the three groups respectively. For hand function as self-reported by participants (measured on the Stroke Impact Scale, scored 0–100 with higher being better), the reported averages were 31.9, 45.0, and 39.4 across the three groups. It is worth noting that these are the scores at the end of the study period, not measures of change from the start, and the trial was quite small in size. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04102956 · results posted 1 March 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT04102956) enrolled 80 people in total — 42 in a group that received a medicine called Kallikrein alongside standard treatment, and 38 in a group that received standard treatment alone. All 80 participants completed the trial with no dropouts reported. The trial was measuring several things before and after treatment, including two proteins found in the blood (Myelin Basic Protein, or MBP, and Vascular Endothelial Growth Factor, or VEGF), as well as scores from standard clinical rating tools used to assess stroke recovery — the Barthel Index (which measures ability to carry out daily activities), the NIHSS (a scale of stroke-related nerve damage), and muscle strength. Researchers also used a brain imaging measurement called Fractional Anisotropy (FA), which reflects how intact nerve fibre bundles are in the brain. The reported data shows the following numbers at the end of treatment. For MBP (a protein that can indicate nerve damage, measured in pg/ml), the Kallikrein group recorded 0.41 and the standard treatment group recorded 0.71. For VEGF (a protein involved in blood vessel activity, measured in ng/ml), the Kallikrein group recorded 29.53 and the standard treatment group recorded 22.91. On the Barthel Index (0–100, where higher means better daily function), the reported change score was 17.5 for the Kallikrein group and 12.5 for the standard treatment group. On the NIHSS stroke severity scale (0–42, where higher means more severe), the reported change from admission to end of treatment was 2.88 points for the Kallikrein group and 2.16 points for the standard treatment group. For muscle strength (graded 0–5, where 5 is normal), both groups recorded a change of 1 grade. For the brain imaging FA decline rate (a lower rate suggesting better nerve fibre integrity), the Kallikrein group recorded 0.036 and the standard treatment group recorded 0.09. It is worth noting that the data as submitted does not include measures of spread or variability (such as ranges or confidence intervals) for these figures, so the precision of these numbers cannot be fully assessed from the available information. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03562663 · results posted 20 January 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT03562663) involved 82 people in total, split into two groups of 41. One group received active tDCS (transcranial direct current stimulation — a technique that passes a very mild electrical current through the scalp to the brain), while the other group received sham tDCS (a dummy version designed to feel similar but without the active stimulation). The trial was measuring changes in upper limb motor function — that is, how well participants could use their arm and hand — using a standard assessment tool called the Fugl-Meyer scale, which runs from 0 to 66 points, where higher scores mean better movement ability. By the end of the study, 34 people in the active tDCS group and 35 in the sham group had completed the trial. The reported data shows that both groups improved their Fugl-Meyer scores from the start of the trial to the end. The active tDCS group had an average improvement of 7.0 points on the 66-point scale, while the sham tDCS group had an average improvement of 7.7 points. These figures represent the change from each group's starting score — not their total scores — so they reflect how much movement ability appeared to shift over the course of the trial for each group. It is worth noting that the results as submitted only included this one primary outcome measure, and no secondary outcome measure data was reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03442868 · results posted 20 November 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT03442868) involved 15 participants who all completed the study — none dropped out. The trial looked at the effects of a brain stimulation technique called high-frequency repetitive transcranial magnetic stimulation (rTMS), which uses magnetic pulses directed at the brain. The main thing being measured was how participants' walking speed changed, while several secondary measures looked at step length, the time spent balancing on one foot during walking, and performance on a mental counting task. The reported data shows the following numbers for walking speed (measured in metres per second): three separate measurements of change were recorded, coming in at −0.49, −0.80, and +5.49. For step length (in centimetres), two change scores were reported: 2.24 and 1.38. For the time spent on one foot during a walking cycle (expressed as a percentage of the full walking cycle), the reported changes were 0.63 and 2.50. For the counting-backwards task, three change scores were reported: −0.18, −0.59, and −0.65. It is worth noting that the data as submitted does not clearly label what each individual measurement represents (for example, which time point or condition each number belongs to), so the figures above are listed as they appear in the submitted results without further interpretation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01811693 · results posted 29 October 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT01811693) was designed to test three increasing dose levels of a treatment, referred to as Dose Tier 1, Dose Tier 2, and Dose Tier 3. In total, only 4 people took part, all of them in the lowest dose group (Dose Tier 1). No participants were enrolled in the two higher dose groups. The main thing the trial was measuring was how many participants had a notable change in their systolic blood pressure (the "top" number in a blood pressure reading) — specifically, a drop or rise of 8 millimetres of mercury (mmHg) or more — about 15 minutes after the treatment was applied in an Emergency Department setting. The reported data shows that of the 4 participants in Dose Tier 1, 1 person had a systolic blood pressure change of 8 mmHg or more. The reported data also shows that 2 participants experienced what are called serious adverse events — that is, significant unwanted medical occurrences during the trial. Additionally, 1 participant showed a notable worsening in their level of consciousness, as measured by a scoring tool called the Glasgow Coma Scale (a 3–15 point scale where lower scores indicate reduced consciousness). The reported data shows that no participants had their systolic blood pressure drop below 120 mmHg. Because only 4 people were enrolled and the two higher dose groups had no participants at all, the data available from this trial is very limited. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01007136 · results posted 22 September 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 61 people across five groups. Most participants were stroke survivors being studied for upper arm movement, and they were divided into groups receiving either a brain stimulation technique called tDCS (transcranial direct current stimulation — a mild electrical current applied to the scalp) combined with occupational therapy, a "sham" (fake/inactive) version of tDCS combined with occupational therapy, tDCS without arm movement practice, sham without arm movement practice, or a control group who had brain scans only with no treatment. A total of 53 people completed the study; eight dropped out across the two main treatment groups. The main thing being measured was arm movement ability, using a scoring tool called the Upper Extremity Fugl-Meyer scale, where 0 means no movement and 66 means full movement. The reported data shows scores were recorded at multiple time points. For the group receiving tDCS with occupational therapy, scores went from around 30 at the start, to about 32, and then 33 by the final measurement. For the sham with occupational therapy group, scores went from around 37 at the start, rising to about 48, and then 56 by the final measurement. The groups without arm movement practice started much lower (around 8 and 5) and showed little change over time. A secondary measure called the Wolf Motor Function Test — which rates how quickly participants could perform arm tasks — showed the reported data shows scores of about 20 for the tDCS-plus-therapy group and about 31 for the sham-plus-therapy group, with near-zero scores for the no-arm-movement groups. A brief cognitive (thinking and memory) test was also recorded, with all groups scoring in the mid-to-high 20s out of 30. No results were reported for the pain scale measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02586233 · results posted 9 September 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT02586233) tested a drug called DS-1040b in people who had recently had an acute ischaemic stroke — the type of stroke caused by a blockage in a blood vessel in the brain. A total of 106 participants took part across six groups, each receiving a different dose of DS-1040b (ranging from 0.6 mg up to 9.6 mg), plus a separate group of 26 people who received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring unwanted medical events that occurred during treatment (called adverse events), and secondarily tracking how the drug moved through the body and whether it had any effect on a blood protein involved in clot breakdown, as well as changes in stroke severity scores over 30 days. The reported data shows that, across all DS-1040b dose groups combined, 63 out of 80 participants experienced at least one adverse event during the treatment period, compared with 18 out of 26 in the placebo group. Regarding how the drug was absorbed into the bloodstream, the peak concentration measured in the blood generally increased with higher doses — for example, 10.09 ng/mL at the lowest dose rising to 203.70 ng/mL at the highest dose, though the 4.8 mg group showed a notably higher peak of 729.76 ng/mL. The time the drug stayed in the body (its "half-life" — roughly how long it takes for half the drug to leave the body) also varied by dose, ranging from about 2.6 hours at the lowest dose to around 36–37 hours at the higher doses. For stroke severity, all groups — including the placebo group — showed reductions in their stroke severity scores at day 30 (a lower score means less impairment); the reported changes ranged from −2.06 to −6.2 across the DS-1040b groups, and −3.6 in the placebo group. Results for the blood protein activity measure (TAFIa) were partially reported and varied across dose groups; full figures for all groups were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02089464 · results posted 1 September 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 199 people who had experienced a stroke — 132 in a group receiving a brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) combined with task-based physical rehabilitation, and 67 in a comparison group who received a "sham" (inactive) version of the same stimulation alongside the same rehabilitation. The sham group was included so researchers could compare results between people who received the real stimulation and those who did not. Of those who started, 104 and 51 participants respectively completed the study. The trial was primarily measuring improvement in arm and hand movement, scored using a standard tool called the Upper Extremity Fugl-Meyer scale, at six months after treatment. The reported data shows that, for the primary measure, 88 out of 104 participants in the rTMS plus rehabilitation group, and 43 out of 51 in the sham plus rehabilitation group, reached or exceeded a pre-set threshold of meaningful improvement (a score change of 5 points or more) on the arm movement scale at six months. For the secondary measures, the reported data shows that both groups recorded the same average change on the Arm Research Action Test (a gain of 5.0 points out of a possible 57), and the same average gain on the hand motor function scale (0.5 points out of 7). On the timed movement test, both groups were faster than at the start — the rTMS group by an average of 9.0 seconds and the sham group by 10.6 seconds. Scores reflecting neurological functioning changed by −0.4 and −0.7 points respectively (lower is better on that scale). The daily living impact scale showed an average improvement of 6.7 points in the rTMS group and 8.7 points in the sham group (higher is better, out of 80). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04252092 · results posted 19 August 2020

    According to the results reported on ClinicalTrials.gov, this trial involved 30 adults who had experienced a stroke and had weakness or loss of function on one side of their body. All 30 participants completed the trial — 15 were placed in a "Sensory Group" and 15 in an "Electrical Stimulation Group." The trial was measuring several types of body-sense awareness in the affected foot and lower leg, including the ability to sense joint position, detect movement direction, feel vibration, feel deep pressure or pain, distinguish two nearby touch points, and recognise shapes traced on the sole of the foot. All of these were tested before and after the treatment period. The reported data shows that both groups had changes in their scores across all six measurements between the start and end of the study. For joint position sense (scored out of 10 correct responses), the Sensory Group went from an average of 5.0 to 8.1, and the Electrical Stimulation Group went from 6.4 to 8.6. For detecting movement direction (also out of 10), the Sensory Group moved from 5.3 to 8.4, and the Electrical Stimulation Group from 6.8 to 8.5. For vibration detection, the Sensory Group went from 2.5 seconds to 6.6 seconds, while the Electrical Stimulation Group went from 4.2 to 6.4 seconds. For deep pain sense — where a "positive" result (feeling pain when squeezed) was considered an unwanted outcome — the Sensory Group went from 66.7% to 13.3% positive, and the Electrical Stimulation Group from 53.3% to 6.7% positive. For two-point discrimination (a smaller number in centimetres is considered better), the Sensory Group went from 7.5 cm to 3.1 cm, and the Electrical Stimulation Group from 6.9 cm to 3.6 cm. Finally, for recognising shapes traced on the foot (out of 10), the Sensory Group went from 3.9 to 6.8, and the Electrical Stimulation Group from 3.1 to 5.7. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03767894 · results posted 7 July 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT03767894) involved 12 people who had experienced a stroke and had reduced arm and hand function on one side. All participants used a device called the MyHand Orthosis — a robotic hand brace — and there was no comparison group. The trial was measuring arm and hand function using several standard tests, given before and after a training programme of 12 sessions. Eleven of the 12 participants completed the full programme; one did not complete it. The reported data shows the following numbers for the main tests. On the Action Research Arm Test (a 0–57 scale measuring how well someone can grasp, grip, and move their arm, where higher is better), scores were reported at three time points: 13.46, 14.82, and 13.09. On the Upper Extremity Fugl-Meyer scale (a 0–66 scale of arm movement ability, where higher is better), two scores were reported: 25.36 and 28.00. For a secondary test called the Box and Blocks Test (counting how many blocks a person can move in 60 seconds with their affected hand), the reported scores across time points were 47, 35, and 24. On the Modified Ashworth Scale — which rates muscle stiffness from 0 (no stiffness) to 4 (very stiff) — the reported median scores across different muscle groups ranged from 0 to 2. The reported data also shows that zero adverse events (unexpected harmful occurrences) were recorded during the intervention, though what this means for any individual is not something that can be drawn from this data alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02132650 · results posted 9 June 2020

    According to the results reported on ClinicalTrials.gov, this trial involved 38 people in total — 20 in a group called "Accurate Walking Training" and 18 in a group called "Steady State Walking Training." By the end of the study, 17 and 14 people respectively had fully completed it, with a small number leaving each group before the end. The trial was measuring whether either type of walking training programme led to a change in how fast participants walked at their own comfortable pace, both right after the programme finished (at 3 months) and again later (at 6 months). The reported data shows that both groups had an increase in their comfortable walking speed after the 3-month programme. In the Accurate Walking Training group, walking speed increased by an average of 0.13 metres per second, while in the Steady State Walking Training group it increased by an average of 0.14 metres per second. When participants were checked again at 6 months, the reported data shows the Accurate Walking Training group had an average increase of 0.10 metres per second from where they started, compared with 0.07 metres per second in the Steady State Walking Training group. These numbers represent the average change across each group from their starting point, as reported by the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04348851 · results posted 18 May 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT04348851) involved 53 people in total, all of whom were caregivers. Participants were divided into four groups: a 4-week intervention group (13 people), an 8-week intervention group (13 people), an 8-week attention control group (13 people — a group that received a different type of contact, used as a comparison), and a standard care group (14 people). The trial was measuring whether the interventions were associated with changes in depressive symptoms, feelings of caregiver burden, physical health-related quality of life, and perceived stress. Measurements were taken at two points after the programs ended. The reported data shows the following changes in scores from the start to each follow-up point (a negative number means the score went down, and a positive number means it went up). For depressive symptoms (scored 0–60, where higher means more symptoms), at the first follow-up, scores changed by −2.31, +1.00, +0.08, and +3.9 for the four groups respectively; at the second follow-up, changes were +0.92, −1.50, −3.46, and +1.92. For caregiver burden (scored 0–48, where higher means more burden), at the first follow-up changes were −0.92, +0.18, −0.62, and +0.14; at the second follow-up, −0.08, −0.40, −0.38, and −0.54. For perceived stress (scored 0–16, where higher means more stress), score changes were +1.23, +0.27, +0.15, and +1.86 across the four groups. For physical health-related quality of life (where higher scores indicate better quality of life), changes were +0.70, +1.91, −3.18, and +0.50. It is worth noting that this was a relatively small trial with 53 participants across four groups, so the numbers in each group are quite small. No data for the emotional quality-of-life scale appears to have been reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03086551 · results posted 27 April 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people in total — five in each group — who had experienced a stroke. It used a "crossover" design, meaning participants were intended to receive both treatments in different orders: one group started with active brain stimulation combined with movement practice, then switched to a sham (inactive/placebo-style) version combined with movement practice, while the other group did the reverse. The trial was measuring things like how quickly participants could complete a series of touch-screen movement tasks, how well they performed everyday hand tasks, and changes in brain activity signals. However, the reported data shows that only two of the original ten participants completed the full crossover, which is important context for understanding the numbers below. The reported data shows that, for the main measure — the time taken to complete a sequence of touch-screen movements — participants in the active stimulation group recorded an average of 8.68 seconds at the start and 8.32 seconds after the intervention, a reported change of 0.37 seconds. In the sham group, the starting average was 8.84 seconds and the post-intervention average was 7.96 seconds, a reported change of 0.88 seconds. For a standard hand-function test involving everyday tasks, the active group's total time went from 95.68 seconds at baseline to 100.05 seconds after intervention (a reported change of −4.38 seconds, meaning times went up slightly), while the sham group went from 86.07 seconds to 76.27 seconds (a reported change of +9.80 seconds, meaning times came down). Changes in brain activity signals (measured in microvolts) and percentage changes in those signals were also reported across both groups at various time points, but given the very small number of participants who completed the full study, the data as reported on ClinicalTrials.gov is limited in scope. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03054064 · results posted 7 April 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT03054064) enrolled 48 people who had weakness or paralysis on one side of the body (hemiplegia) following a stroke. The trial was testing the Indego, a powered exoskeleton device worn on the legs to assist with walking. Of the 48 people who started, 2 did not pass the initial screening, 42 completed the study, and 6 did not finish for other reasons. The trial was primarily looking at adverse events (unexpected or unwanted experiences) reported while using the device, and also measured things like muscle stiffness, walking ability, walking speed, and pain at different time points. The reported data shows that, for the primary measure, 3 adverse events and 0 serious adverse events were recorded across all enrolled participants. For muscle stiffness (measured on a scale from 0 to 4, where 0 means no stiffness and 4 means the limb is completely rigid), the reported score was 1 at each measurement point for both arms and legs. For walking ability (measured on a scale from 1 to 6, where higher means more independent), the reported score was 5 at both time points measured. The reported data shows that walking speed without the device, measured by timing how long it took to walk 10 metres, was 24.4 seconds at one point and 19.4 seconds at another. For pain (on a scale of 0 to 10, where 0 is no pain), the reported score was 0 at both time points. It is worth noting that the data as submitted shows single values rather than averages across the group for several measures, and no breakdown of individual participant results was reported, which limits what can be understood from these numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT02039375 · results posted 23 March 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people who had received a clot-dissolving drug called IV tPA (a common treatment given after a stroke). All participants followed a specific post-treatment monitoring approach called the "Hopkins" protocol, which is designed to watch over stroke patients in the hours after receiving tPA. Thirty-three of the 35 participants completed the study, while two did not complete it (the reasons were not detailed in the reported data). The trial was measuring whether patients needed intensive care unit (ICU) level care in the first 24 hours, how severe their stroke symptoms were at 24 hours and again at 90 days, how much disability they had at those same time points, and how many had died by 90 days. The reported data shows the following results, all expressed as group median scores (the middle value when all results are lined up in order). For the primary question — how many participants needed ICU-level care or procedures in the first 24 hours after tPA — the reported number was zero participants. For stroke severity at 24 hours, participants' scores on the NIHSS scale (which runs from 0 for no stroke symptoms to 42 for the most severe) had a median of 1, which sits in the "minor stroke" range. The disability score (the mRS scale, running from 0 meaning no symptoms to 6 meaning the person has died) also had a median of 1 at 24 hours, meaning some symptoms but able to manage daily activities without help from others. At 90 days, both the stroke severity score and the disability score had a median of 0. The reported data also shows that 1 participant had died by the 90-day mark. It is worth noting that this was a single-group study with no comparison group, and the reported figures are group medians rather than results for any individual person. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03305731 · results posted 19 February 2020

    According to the results reported on ClinicalTrials.gov, this trial tested a program called "Activating Behavior for Lasting Engagement" with 21 people enrolled at the start. One person did not complete the study, so 20 participants finished. The trial was measuring changes in sitting behaviour — specifically how much time people spent sitting in long, unbroken stretches (periods of 30 minutes or more), how often they took breaks from sitting, and how much they participated in meaningful daily activities. Sitting time and breaks were tracked using a small body-worn device called an ActivPAL, and participation was measured using a questionnaire called the Stroke Impact Scale. The reported data shows that, on average, the amount of time participants spent sitting in long unbroken bouts changed by 54.95 minutes (primary measure) and 14.08 minutes (secondary measure) across different measurement points. The reported data also shows that the number of breaks from sitting changed by 2.61 breaks per day (primary measure) and -2.55 breaks per day (secondary measure) at different time points — note that a negative number here means fewer breaks on average at that particular point. For the participation questionnaire, which is scored from 0 to 100 (where higher scores suggest greater participation), the reported changes were 1.48 points and 1.33 points at the two measurement time points. The data does not include information about whether these changes were compared to a control group, as this appears to have been a single-group study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT01327846 · results posted 22 January 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT01327846) enrolled a large number of participants across four groups. In the core phase of the trial, the groups started with 2,263, 2,284, 2,170, and 3,344 people respectively — a total of around 10,061 participants. The trial was measuring cardiovascular (heart and blood vessel) events over time, comparing the groups to see how many people experienced serious events such as heart attacks, strokes, or cardiovascular-related death. Some participants also continued into an extension phase. The reported data shows that for the main (primary) outcome — a combined measure of cardiovascular death, non-fatal heart attack, or non-fatal stroke — the number of participants who experienced at least one of these events was 322 in Group I, 320 in Group II, 313 in Group III, and 535 in Group IV. When looking at cardiovascular deaths specifically, the reported figures were 151, 144, 137, and 235 across the four groups. For non-fatal strokes, the numbers were 174, 159, 169, and 292. The reported data shows that for a broader secondary outcome that also included hospitalisation for unstable chest pain requiring unplanned procedures, the totals were 348, 352, 344, and 601 participants across the four groups. For the outcome of new-onset type 2 diabetes among those who had pre-diabetes at the start, the numbers reported were 169, 171, 161, and 246. It is worth noting that the data for two other primary outcomes — relating to artery plaque and insulin secretion — were not reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02447081 · results posted 30 December 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 1,088 people who received an implanted device called the Amulet, which is designed to close off a small pouch in the heart (the left atrial appendage) to help reduce the risk of blood clots in people with an irregular heartbeat. The trial tracked participants over two years and measured a range of outcomes related to serious medical events, procedure success, and major bleeding. Of the 1,088 who started, 864 completed the study, and 224 did not complete it (the reasons were not broken down in the reported data). The reported data shows that, out of 1,088 participants, 83 people experienced a serious adverse event (an unexpected harmful medical occurrence) within the first 7 days after the procedure, while 504 people experienced a serious adverse event more than 7 days after the procedure. Over the two-year follow-up period, 122 participants experienced either a stroke caused by a blood clot, a blood clot travelling to another part of the body, or death related to the heart or blood vessels. Additionally, 110 participants had a major bleeding event, defined using a standard medical scoring scale for serious bleeding. The reported data also shows that the procedure was recorded as technically successful — meaning the device was placed in the intended location in the heart — in 1,078 out of 1,088 participants. Procedural success, which also required that the participant was discharged from hospital the following day without an adverse event, was recorded for 1,039 participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT02034058 · results posted 2 December 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02034058) enrolled 152 participants, all of whom received a stenting procedure (the placement of a small tube-like device inside a blood vessel to help keep it open). Of those 152 people, 149 completed the study and 3 did not. The trial was measuring how often participants experienced a stroke or died within 72 hours of the procedure, as well as several related outcomes tracked over the following weeks. The reported data shows that out of 152 participants, 4 experienced either a stroke or death within 72 hours of the stenting procedure — this was the main outcome the trial was designed to measure. Looking at the more detailed, secondary outcomes: 1 participant was reported to have had an ischaemic stroke (a stroke caused by a blockage reducing blood flow to the brain); 2 participants were reported to have died from neurological causes (causes related to the brain or nervous system); and 4 participants were reported to have had a stroke in the specific area of the brain supplied by the artery that was stented. When it came to stroke recovery — measured at 90 days after the procedure and defined as returning to the same level of functioning the person had before — the reported data shows 0 participants met that definition. The data does not report what proportion of participants had already experienced a stroke before the procedure, so it is not possible to know how many were eligible to "recover" in this specific sense. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02111564 · results posted 25 November 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02111564) enrolled just over 12,000 people in total — approximately 6,007 in the rivaroxaban group (a blood-thinning medication, taken as either a 10 mg or 7.5 mg daily dose) and 6,012 in the placebo group (an inactive tablet). The trial was measuring two main things over a 45-day follow-up period: how often participants experienced a blood clot in a vein or died from such a clot, and how often participants experienced a serious bleeding episode. All events were reviewed by an independent medical committee. Results are expressed as the number of events for every 100 participants over that 45-day period. The reported data shows that for the main clotting outcome — combining symptomatic blood clots in the veins and deaths related to those clots — the rivaroxaban group had a reported rate of 0.84 events per 100 participants, compared with 1.11 events per 100 participants in the placebo group. For serious bleeding, the reported rate was 0.28 per 100 participants in the rivaroxaban group and 0.15 per 100 participants in the placebo group. For the secondary outcomes, the reported data shows: deaths related to blood clots occurred at a rate of 0.72 (rivaroxaban) versus 0.77 (placebo) per 100 participants; symptomatic blood clots alone occurred at 0.19 versus 0.42 per 100 participants; the combined rate of blood clots and death from any cause was 1.31 versus 1.80 per 100 participants; and a broader combined outcome including heart attacks, non-bleeding strokes, and cardiovascular deaths was reported at 1.58 versus 2.03 per 100 participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03261167 · results posted 18 October 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 124 adults in total — 63 in a lower-dose group (240 units of GSK1358820) and 61 in a higher-dose group (400 units). The trial was measuring the effects of this botulinum toxin injection on muscle stiffness (called spasticity) in the arm, specifically in the elbow, wrist, finger and thumb muscles. Participants were followed through up to four treatment cycles, each lasting up to 48 weeks. The main thing the trial set out to measure was how many people in each group had at least a one-point improvement on a standard muscle stiffness rating scale (called the Modified Ashworth Scale, or MAS, which runs from 0 to 4) in the elbow muscles at six weeks. The reported data shows that at the six-week mark, around 50.8% of participants in the 240-unit group and 68.9% in the 400-unit group had at least a one-point improvement in elbow muscle stiffness scores. For the secondary measurements — which looked at stiffness scores in the elbow, wrist, fingers and thumb up to 12 weeks — the reported percentage of participants showing improvement ranged from roughly 33% to 83% across the different muscle groups and time points, depending on the dose and muscle area being measured. Scores on the disability scale (which measured things like hygiene, dressing and limb posture on a 0–3 scale) also showed small reported reductions from starting levels in both groups across the 12-week period. Regarding unintended medical events, the reported data shows that over the full study period, 52 participants in the 240-unit group and 49 in the 400-unit group experienced at least one adverse event, while 6 and 8 participants respectively experienced a serious adverse event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01412554 · results posted 10 October 2019

    According to the results reported on ClinicalTrials.gov, this trial involved 103 participants, all of whom completed the study with no dropouts. The trial was a long-term follow-up study (10 to 20 years after an earlier study) looking at how sensitive participants' bodies were to insulin — that is, how well the body responds to insulin to manage blood sugar levels. To measure this, researchers used a specialised medical procedure called a glucose clamp, where insulin and sugar are given through a drip while blood sugar is carefully controlled, allowing the research team to calculate how much sugar the body was processing. The reported data shows that the main measurement — called the glucose disposal rate, which reflects how much sugar the body takes up per kilogram of body weight per minute — was reported as 7 mg/kg/min for the study group. This is the average figure recorded during the final 20 minutes of a 2-hour glucose clamp procedure. For the secondary outcomes — which included measures of stress hormone activity (adrenaline and noradrenaline), heart ultrasound findings, and abdominal fat measured by ultrasound — no numerical results were reported in the ClinicalTrials.gov submission, so those figures are not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02239120 · results posted 6 September 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02239120) enrolled 5,390 people in total — 2,695 in each group. One group took dabigatran etexilate (110 mg or 150 mg) and the other took aspirin (100 mg). The trial was measuring two main things: how often participants had another stroke, and how often participants experienced a major bleed (serious internal or external bleeding). The vast majority of participants in both groups completed the study — 2,620 in the dabigatran group and 2,623 in the aspirin group. The reported data shows the following for the two primary (main) outcomes. For recurrent stroke — meaning another stroke of any type — the dabigatran group had a reported rate of 4.09% per year, compared with 4.80% per year in the aspirin group. For major bleeds, the dabigatran group had a reported rate of 1.84% per year, compared with 1.33% per year in the aspirin group. These rates are "annualised," which simply means they have been calculated to represent what would happen on average over one year. The reported data also shows several secondary (additional) outcomes: ischaemic stroke (a stroke caused by a blockage) was reported at 3.97% per year for dabigatran versus 4.71% for aspirin; a combined measure of non-fatal stroke, non-fatal heart attack, or cardiovascular death was 4.80% versus 5.40%; strokes that caused significant disability were 0.55% versus 0.93%; and death from any cause was 1.24% versus 1.28%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01603615 · results posted 21 August 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT01603615) enrolled 220 people who received the treatment BOTOX®. Of those, 213 people actually received the treatment and were included in the safety analysis, 186 people completed the study, and 34 did not finish. The trial was measuring safety-related experiences — specifically, tracking whether participants had any unexpected medical events (called "treatment-emergent adverse events") that occurred after receiving the treatment. The reported data shows that the only outcome measure submitted was related to these medical events. Out of the 213 participants included in the safety analysis, 58.7% — meaning roughly 6 in every 10 participants — reported experiencing at least one such event during the study period. It is important to note that these events are not automatically linked to the treatment itself; they simply refer to any medical occurrence that happened during or after the treatment period. No other outcome measures — such as measures of how well the treatment performed — appear to have been reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02653170 · results posted 16 August 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 265 people who had recently been discharged from hospital after a stroke, along with their caregivers. Participants were divided into three groups: one group received usual care (87 people), one received a support programme called SWSCM (88 people), and one received SWSCM combined with access to a website called the VSSP (90 people). Not everyone completed the study — 70, 72, and 72 people finished in each group respectively. The trial was measuring changes in quality of life, mental wellbeing, and caregiving experience over 90 days after discharge. The reported data shows the following for the primary outcomes, where scores are measured as the change from shortly after discharge to 90 days later (a higher number meaning more improvement). For physical health quality of life, the usual care group changed by 0.29 points, the SWSCM group by 1.26 points, and the SWSCM-plus-website group by 3.66 points — all on a scale where the general population average sits around 50. For mental health quality of life, the changes were 1.19, 0.12, and 1.45 points respectively. For caregivers, a questionnaire measuring how caregiving had affected their lives showed changes of 1.93, 0.65, and 1.96 points respectively, on a scale of 15 to 105. For the secondary outcomes, a measure of how well patients felt equipped to manage their own health changed by 0.87, −0.78, and 5.90 points across the three groups. A measure of caregiver depression symptoms (where a lower score is better) changed by −0.92, −1.01, and −0.95 respectively. The reported data for the patient anxiety scale was not provided in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01907737 · results posted 19 July 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 22 people, with 21 completing the study and 1 not completing it. The trial used a "cross-over" design, meaning each participant tried all four different combinations of two treatments — transcranial direct current stimulation (tDCS, a mild electrical stimulation applied to the scalp) and peripheral nerve stimulation (PNS, electrical stimulation applied to the arm) — in separate sessions. Some sessions used the real ("active") version of each treatment, and others used a dummy ("sham") version that mimicked the procedure without delivering the actual stimulation. The main thing being measured was how far participants could actively bend their wrist upward on their affected side, recorded in degrees of movement, before and after each session. The reported data shows that wrist movement was measured before and after each of the four treatment combinations. Before treatment, the reported average wrist extension ranged from approximately 37.2 to 38 degrees across all four groups. After treatment, the reported averages ranged from approximately 36.2 to 37.4 degrees across the four groups. These figures represent the degree of wrist movement recorded at those two time points for each intervention condition. No secondary outcome data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03276494 · results posted 9 July 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT03276494) involved six people who received a treatment delivered through an intraosseous route — meaning directly into the bone marrow rather than through a standard vein. Five of the six participants completed the study, while one did not finish. The trial was measuring two things: whether participants experienced any tissue damage at or near the site where the treatment was delivered, and how much pain participants appeared to be in (since all participants were non-verbal, pain was assessed by clinicians using a standardised observation tool called the CPOT, which scores pain on a scale from 0 to 8, where 0 means no pain and 8 means the highest level of pain). The reported data shows that, across both outcome measures, the recorded values were zero. Specifically, none of the participants were reported to have experienced tissue damage — such as skin or bone-related complications — as assessed by clinicians. The reported data also shows a pain observation score of zero, meaning that at the time of assessment, clinicians observed no indicators of pain in the participants using the CPOT tool. It is worth noting that this was a very small group of six people, and the data as submitted does not include any longer-term follow-up information beyond what was measured during the study period. Any figures not included in the submitted results data have not been reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02331407 · results posted 7 May 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 9 participants, all of whom completed the study with no drop-outs. All 9 participants received robot-assisted arm rehabilitation therapy. The trial was measuring arm motor control — specifically, how well participants could make controlled reaching movements — as well as broader arm and hand function using two established assessment tools. The reported data shows that the main (primary) outcome measured changes in arm motor control using a mathematical scoring method based on the shape of reaching movements (called the average squared Mahalanobis distance — a unitless number where a lower score after treatment means movement became more controlled, and a higher score means it became less controlled). The reported change from the start of the trial was −16.31, meaning the score went down over the course of the study. For the two secondary outcomes, the Fugl-Meyer Upper Extremity Assessment — a scale from 0 to 66 where higher scores indicate better arm, wrist, hand, and coordination ability — showed scores of 30.3, 32.8, 36.0, and 38.3 across four measured time points. The Action Research Arm Test — a scale from 0 to 57 measuring hand and arm tasks such as grasping and gripping, where higher scores indicate better function — showed scores of 19.6, 21.3, 23.7, and 25.0 across the same four time points. The specific time points for these measurements were not detailed in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01313767 · results posted 29 March 2019

    According to the results reported on ClinicalTrials.gov, this trial compared two botulinum toxin products — Meditoxin® and Botox® — in people with upper limb spasticity (muscle stiffness or tightness) following a stroke. A total of 98 people were assigned to each group (196 in total). The trial mainly measured changes in muscle tone in the wrist, and also tracked muscle tone in the elbow, fingers, and thumb over 12 weeks. Muscle tone was scored using a scale called the Modified Ashworth Scale (MAS), which runs from 0 (no stiffness) to 4 (limb completely rigid). The reported data shows that, at the start of the trial, average wrist muscle tone scores were 2.41 for the Meditoxin® group and 2.52 for the Botox® group. By week 4 (the main measurement point), those scores had moved to 1.02 and 0.96 respectively — a reported change of −1.39 for Meditoxin® and −1.56 for Botox®. Similar patterns in the numbers were reported at weeks 8 and 12 for the wrist, and across the elbow, finger, and thumb measurements. For the wrist, the reported data also shows that at week 4, 77 out of 98 participants in the Meditoxin® group and 88 out of 98 in the Botox® group had a score that improved by at least 1 point on the scale; at week 8 those numbers were 77 and 80, and at week 12 they were 71 and 77. The reported data shows that both groups had lower MAS scores at follow-up compared to the start of the trial across all muscle groups measured, with the numbers between the two products appearing broadly similar at each time point. No safety data was included in the structured results submitted to ClinicalTrials.gov, so that information is not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02787694 · results posted 25 March 2019

    According to the results reported on ClinicalTrials.gov, this trial involved 22 participants who all took part in a programme called Factor Targeted Walking Training. Five people did not complete the study, leaving 17 who finished. The trial was measuring walking ability, specifically using a standard test called the 10 Metre Walk Test, where participants walk a short distance and their speed is recorded in metres per second. Measurements were taken at the start of the programme and again after 10 weeks. The reported data shows that at the start of the programme, the average walking speed recorded was 0.64 metres per second. At the 10-week mark, the average walking speed recorded was 0.79 metres per second. These are the only outcome figures reported in the structured data submitted to ClinicalTrials.gov — no other outcome measures were included in the data provided, so no further results can be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02858349 · results posted 15 March 2019

    According to the results reported on ClinicalTrials.gov, this trial involved 10 participants, all in a single group (Arm 1). All 10 people who started the trial completed it, with no drop-outs. The trial was measuring several aspects of how people move and function, including walking speed, walking symmetry, the energy the body uses while walking, fitness capacity, thinking and memory skills, and standing balance. The reported data shows that for the primary outcome — walking speed, measured using a standard 10-metre walk test — the recorded result was 0.13 metres per second. To give that some context, this is a measure of how quickly participants covered a short distance on foot. For the secondary outcomes — including walking symmetry, energy used during walking, fitness levels during exercise, thinking and memory scores, and standing balance — no results were reported in the data submitted to ClinicalTrials.gov. Because most of the secondary outcome results were not reported, it is not possible to describe what those measurements showed. The trial was small, with only 10 participants, and the data available covers only a portion of what was originally being measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03318341 · results posted 6 March 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT03318341) involved 26 people in total, split into two groups of 13. It used a "crossover" design, meaning each group tried both a real device and a sham (inactive/dummy) version of the device — one group used the real device first, then the sham, while the other group did it the other way around. The trial was measuring two main things: whether people stuck with wearing the device as instructed, and whether any unwanted events related to the device occurred. The reported data shows that, when it came to compliance (sticking with wearing the device), all participants who were still in the trial at each stage completed their assigned period — 13 out of 13 in the "Real Then Sham" group and 12 out of 12 in the "Sham Then Real" group across both months. Regarding unwanted events possibly linked to the device, the reported data shows that in the first month, 2 participants in the "Real Then Sham" group and 4 participants in the "Sham Then Real" group experienced such events. In the second month, no participants in the "Real Then Sham" group reported such events, while 1 participant in the "Sham Then Real" group did. No further breakdown of what those events involved was included in the submitted results data. One participant left the trial during the first month, though the reason was not reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02313909 · results posted 9 January 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02313909) enrolled 7,213 people in total — 3,609 in the rivaroxaban 15 mg group and 3,604 in the aspirin 100 mg group — with the vast majority completing the study. The trial was measuring two main things: how often participants experienced a stroke or a clot travelling to another part of the body (called systemic embolism), and how often participants experienced a serious bleeding event. These two main measures were tracked over time and reported as the number of events per 100 people per year, which is simply a way of comparing rates across groups of different sizes studied over varying lengths of time. The reported data shows that for the first main measure — stroke or systemic embolism — the rivaroxaban group had a rate of 5.14 events per 100 person-years, compared with 4.78 in the aspirin group. For the second main measure — serious bleeding events — the rivaroxaban group had a rate of 1.82 events per 100 person-years, compared with 0.67 in the aspirin group. For the secondary outcomes, the reported rates were also broadly similar between the two groups for combined cardiovascular death, recurrent stroke, systemic embolism and heart attack (6.20 vs 5.85), and for deaths from any cause (1.88 vs 1.50). Life-threatening bleeding was reported at 1.02 events per 100 person-years in the rivaroxaban group and 0.43 in the aspirin group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00991029 · results posted 4 December 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 4,881 participants in total — 2,432 in the clopidogrel group and 2,449 in the placebo group (a placebo is a dummy treatment with no active ingredient). The trial was measuring two main things: firstly, how many people experienced a serious blood-vessel-related event — specifically a stroke caused by a blockage, a heart attack, or death from a vascular (blood vessel) cause; and secondly, how many people experienced a major bleed. Around 2,276 and 2,281 participants respectively completed the study in each group. The reported data shows that, for the first main outcome (serious vascular events combined), 121 participants in the clopidogrel group and 160 participants in the placebo group experienced one of these events. For the second main outcome (major bleeding), 23 participants in the clopidogrel group and 10 participants in the placebo group had a major bleed. Looking at the individual secondary outcomes reported, the numbers for blockage-type stroke alone were 112 (clopidogrel) versus 155 (placebo); for heart attack, 10 versus 7; for death from a vascular cause, 6 versus 4; and for any stroke — whether caused by a blockage or a bleed — 116 versus 156. The reported data shows these were the raw counts of how many people in each group experienced each event during the trial period; no further calculations or adjusted figures were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03019744 · results posted 27 September 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT03019744) involved 82 people in total — 38 in the MeCFES group (a type of electrical stimulation applied to the arm during movement) and 44 in a control group. By the end of the study, 32 people in the MeCFES group and 36 in the control group had completed the trial. The trial was measuring changes in arm and hand function after stroke, using several standard questionnaires and tests scored before and after treatment. The reported data shows the following changes in scores from before to after treatment. On the ARAT scale (a 45-point arm movement test, where higher is better), the MeCFES group's score changed by +6.6 points on average, compared with +5.0 points in the control group. On the FMA-UE scale (a 66-point arm function test, where higher is better), the MeCFES group's score changed by +7.8 points on average, compared with +4.5 points in the control group. For the secondary measures: on the IPPA (a 25-point personal problem rating, where lower is better), both groups showed a reduction — MeCFES by −2.8 points and control by −3.2 points. On the DASH questionnaire (a 100-point measure of arm, shoulder and hand disability, where lower is better), MeCFES showed a change of −4.8 points and control showed −7.4 points. Finally, the pain scale (rated 0–10, where lower means less pain) showed no change in either group — both recorded 0. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01584609 · results posted 13 September 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 198 people who had experienced a stroke caused by a blocked blood vessel in the brain. Participants were divided into two groups: 98 people were treated using the Penumbra System together with an additional device called the Separator 3D, and 100 people were treated using the Penumbra System alone. The trial was measuring how well each approach restored blood flow to the blocked vessel, as well as tracking serious unwanted events linked to the device or procedure, and how participants were functioning in the weeks and months after treatment. The reported data shows that, when looking at restoration of blood flow (judged by a standard imaging scale), 82 out of 98 participants in the Separator 3D group and 79 out of 100 in the Penumbra-alone group met the target flow level. Regarding serious unwanted events, the Separator 3D group had 4 device-related and 10 procedure-related serious events, while the Penumbra-alone group had 5 device-related and 14 procedure-related serious events. For recovery at 30 days (measured using standard stroke scoring tools), 58 participants in the Separator 3D group and 55 in the Penumbra-alone group met the definition of a good clinical outcome. At 90 days, 39 participants in the Separator 3D group and 44 in the Penumbra-alone group had low disability scores. The reported data also shows that 19 participants in the Separator 3D group and 26 in the Penumbra-alone group had died by the end of follow-up. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01603602 · results posted 14 August 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 235 children across three groups: 77 received a higher dose of BOTOX® (6 units per kilogram of body weight), 78 received a lower dose (3 units per kilogram), and 80 received a placebo (an inactive treatment). The vast majority of participants completed the study — 75, 78, and 79 respectively. The trial was measuring muscle stiffness (called spasticity) in children, using two main tools: a scale that rates how stiff a muscle feels when a limb is moved (the Modified Ashworth Scale, scored from 1 to 5, where a lower score means less stiffness), and a physician's overall impression of change (scored from −4 meaning marked worsening to +4 meaning marked improvement). The reported data shows that for the muscle stiffness scale, all three groups had lower (improved) scores compared to where they started. The higher-dose group showed an average change of −1.87 points, the lower-dose group −1.92 points, and the placebo group −1.21 points. For the physician's overall impression, the reported averages were 1.87 for the higher-dose group, 1.88 for the lower-dose group, and 1.66 for the placebo group — all sitting in the positive (improvement) direction on that scale. The reported data also shows similar patterns in the secondary measures, including finger muscle stiffness and a range-of-motion measurement, with all groups showing changes from their starting points across the various time points recorded. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02142283 · results posted 20 July 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT02142283) enrolled 206 people who had experienced a stroke — 107 were assigned to a procedure called Trevo Thrombectomy (a catheter-based technique to remove a blood clot from a blocked brain artery) and 99 received standard medical management alone. The trial was measuring how well people recovered from their stroke, using a disability scale called the modified Rankin Scale (mRS), which runs from 0 (no symptoms) to 6 (death). It also tracked how many people achieved functional independence — meaning they could largely look after themselves — as well as stroke-related deaths. The reported data shows that on the mRS disability scale (where a lower score means less disability), the thrombectomy group recorded an average weighted score of 5.5, while the medical management group recorded 3.4. Regarding functional independence (a score of 0–2 on the mRS), 52 out of 107 participants in the thrombectomy group and 13 out of 99 in the medical management group reached that level. For the "early response" measure — a meaningful improvement on a separate stroke severity assessment within the first week — 51 participants in the thrombectomy group and 19 in the medical management group met that threshold. The reported data also shows that stroke-related deaths numbered 17 in the thrombectomy group and 18 in the medical management group, while deaths from any cause were 20 and 18 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02671461 · results posted 12 June 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT02671461) looked at an investigational drug called BMS-986141 in two different doses (0.8 mg and 4.8 mg) compared to a placebo (a dummy treatment with no active ingredient). A total of 15 people took part — 3 in the placebo group, 5 in the lower-dose group, and 7 in the higher-dose group. The trial was measuring two main things: whether participants experienced a stroke or had silent (unrecognised) brain injury detected on a brain scan (MRI) by day 28, and whether participants experienced significant or clinically relevant bleeding during the treatment period. Several secondary outcomes were also tracked, including heart attack, cardiovascular death, and recurrent stroke. The reported data shows that no numerical results were submitted for any of the outcome measures — neither the two primary outcomes nor any of the secondary outcomes. The data fields for all measurements are empty in the results as reported to ClinicalTrials.gov. This means no figures for rates of stroke, brain infarction on MRI, bleeding, heart attack, or any other tracked event were provided in the submitted results. It is worth noting that the trial was very small — only 15 participants started the treatment phase, and a large proportion did not complete it (10 out of 15 did not finish the treatment period). This may help explain why results were not reported, though the reason for the missing data was not stated in the submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01975389 · results posted 12 June 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT01975389) enrolled 10,564 people in total — 5,283 in the placebo group and 5,281 in the bococizumab group. The trial was measuring whether bococizumab, compared to a placebo (an inactive injection), was associated with differences in the rate of serious heart and blood vessel events, such as heart attack, stroke, cardiovascular death, and hospitalisation for severe chest pain requiring urgent treatment. Results were tracked as an "event rate per 100 participant-years," which is a way of counting how many events occurred for every 100 people followed over one year. The reported data shows that for the primary measure — the rate of first major cardiovascular events — the placebo group had a reported rate of 4.19 events per 100 participant-years, while the bococizumab group had a reported rate of 3.33. For the secondary measures, the reported rates were similarly lower in the bococizumab group across several combinations of outcomes: for the grouping of cardiovascular death, non-fatal heart attack, or non-fatal stroke, the placebo group reported 3.58 versus 2.67 in the bococizumab group; for all-cause death, non-fatal heart attack, or non-fatal stroke, the figures were 3.97 versus 3.09; and for the broader grouping that also included hospitalisation for unstable chest pain, 4.59 versus 3.76. For hospitalisation for unstable chest pain requiring urgent treatment alone, the rates were very close — 0.77 for placebo and 0.73 for bococizumab. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01569607 · results posted 16 January 2018

    According to the results reported on ClinicalTrials.gov, this trial involved 22 people in total — 11 in each group. Participants received either a type of brain stimulation called "Hebbian-type stimulation" (which pairs physical movement training with magnetic pulses to the brain) or a "sham" version (a dummy procedure designed to look the same but without the active stimulation). The trial measured several things: activity in the motor area of the brain, the speed and timing of wrist movements, and how well participants used their weaker arm in everyday tasks. The reported data shows the following numbers across three time points — before treatment (baseline), one week after, and four weeks after. For brain activity (measured as the size of electrical responses in the motor area of the brain, in millivolts), the Hebbian group recorded 4.68, 5.01, and 2.66 at the three time points, while the sham group recorded 9.09, 8.04, and 7.66. For wrist movement speed, both groups showed similar figures across time points (roughly 0.61–0.81 units). For reaction time (in milliseconds), the Hebbian group recorded 238.1, 238.43, and 219.63, compared to 257.14, 224.59, and 225.35 in the sham group. For everyday arm use (scored on a scale where higher means more use), the Hebbian group went from 78.67 to 84.67, while the sham group went from 78.00 to 77.33. Quality of arm movement scores (on a 0–5 scale) for the Hebbian group went from 3.41 to 3.92, and for the sham group from 3.17 to 3.33. Hand function test scores (on a scale where lower is better) were 0.38 to 0.31 for the Hebbian group and 0.49 to 0.44 for the sham group. One person in each group did not complete the study, and the reasons were not detailed in the submitted data. It is worth noting this was a small trial with only 10–11 people per group, which limits how broadly any numbers can be interpreted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00590980 · results posted 17 November 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT00590980) enrolled 82 participants, all treated as a single group with no comparison group. The trial was measuring the occurrence of a specific type of stroke — an ischaemic stroke (a stroke caused by a blocked blood vessel) in the vertebrobasilar territory, which refers to the blood vessels at the back of the brain. Of the 82 people who started the trial, 72 completed it, and 10 did not finish for reasons that were not detailed in the reported data. The reported data shows that the primary outcome — the number of participants who experienced a fatal or non-fatal ischaemic stroke in that area of the brain — was recorded as 72 participants. It is not entirely clear from the data as submitted whether this number reflects participants who experienced a stroke, or simply the number of participants assessed for that outcome. No further breakdown or comparison figures were reported in the structured results data, so a fuller interpretation of what this number means in context cannot be drawn from the available information alone. It is also worth noting that because there was only one group and no control or comparison group reported, the data does not include a side-by-side comparison with another treatment or a placebo. Secondary outcome measures were not included in the structured results data provided, so those findings cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01249404 · results posted 17 October 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 388 adults across three groups: 127 received a lower dose of Dysport® (1,000 units), 129 received a higher dose of Dysport® (1,500 units), and 132 received a placebo (an inactive injection). Dysport® is a botulinum toxin product. The trial was measuring muscle stiffness in the lower leg — specifically a condition called spasticity — using a standard rating scale called the Modified Ashworth Scale (MAS). On this scale, a score of 0 means no stiffness and 4 means the limb is completely rigid, so a decrease in score means less stiffness was recorded. The trial also looked at doctors' overall impressions of how participants were doing, and how fast participants could walk barefoot over 10 metres. The reported data shows that for the primary measure — change in lower-leg muscle stiffness at week 4 — all three groups recorded a decrease from their starting scores. The lower-dose Dysport® group showed an average decrease of 0.6 points on the MAS scale, the higher-dose group showed a decrease of 0.8 points, and the placebo group showed a decrease of 0.5 points. For the doctors' overall impression at week 4 (rated on a scale from −4 meaning much worse to +4 meaning much improved), the average score was 0.9 for both Dysport® groups and 0.7 for the placebo group — all sitting just below "slightly improved." For barefoot walking speed at week 4, the reported data shows changes of +0.05 metres per second, +0.04 metres per second, and +0.05 metres per second for the lower-dose, higher-dose, and placebo groups respectively. The reported data also shows that at weeks 1 and 12, MAS score changes followed a broadly similar pattern across all groups, with modest decreases recorded in each. The placebo group consistently recorded decreases alongside the Dysport® groups across all time points reported. Walking speed and doctors' impression scores at week 12 were also similar across all three groups, as noted above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00715520 · results posted 16 October 2017

    According to the results reported on ClinicalTrials.gov, this trial was divided into three separate aims (sub-studies). Aim 1 enrolled 20 participants (10 completed), Aim 2 enrolled 10 participants (9 completed), and Aim 3 enrolled 3 participants (1 completed) — giving a total of 33 people who started the study across all three aims. The trial was investigating how a brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) — where magnetic pulses are delivered to the scalp to briefly influence brain activity — might relate to measurements of brain excitability and wrist movement, taken before and after a training session. The reported data shows that for Aim 1, the primary measures tracked two things: the strength of a brain signal called a motor evoked potential (a tiny electrical response in a muscle triggered by the magnetic pulse, measured in millivolts), and the speed of wrist extension movements (measured in units of gravitational acceleration, or "g"). Brain signal readings across the four time points (before treatment, then immediately after, 30 minutes after, and 60 minutes after) were reported as ranging from roughly 0.73 mV to 1.81 mV. Wrist movement speed readings ranged from approximately 1.22 g to 1.37 g across those same time points. For Aim 2, the secondary outcome measures reported similar types of readings broken down by different settings of the stimulation device (timing and frequency of the pulses); brain signal values ranged from roughly 0.39 mV to 1.14 mV, and wrist movement speed values ranged from approximately 1.33 g to 1.53 g across the various conditions and time points. No outcome data was reported for Aim 3. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01499173 · results posted 29 September 2017

    According to the results reported on ClinicalTrials.gov, this trial involved 101 people who took part in a stroke preparedness programme. The trial had a single group — there was no comparison group. It measured whether participants completed the programme, and also tracked changes in several areas: how likely people said they were to call emergency services (911 in the US) if they spotted a stroke, how well they could recognise stroke symptoms, and how their attitudes, confidence, and sense of what others expected of them shifted over time. The reported data shows that 64 of the 101 people who started the programme completed it, while 37 did not finish. For stroke recognition — scored on a scale of 0 to 9, where 9 means perfect recognition — the average score was 5.9 before the programme and 6.0 afterwards. For the intention to call emergency services — scored on a scale of 0 to 8, where 8 means always responding correctly — the average score was 4.4 before and 5.2 after. For the remaining measures (attitudes toward calling for help, confidence in recognising a stroke, and perceptions of what others would do), the reported data shows a range of small positive and negative figures across different time points; however, the way these figures were calculated and presented in the submitted data makes it difficult to summarise them in simple terms without risk of misrepresentation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00387712 · results posted 14 September 2017

    According to the results reported on ClinicalTrials.gov, this trial looked at two different approaches to treadmill training for people who had experienced a stroke. One group followed a programme based on walking speed (velocity-based), and the other followed a programme based on how long they walked (duration-based). A total of 99 people started the trial — 47 in the speed-based group and 52 in the duration-based group. However, the reported data shows that a large number of participants did not finish: only 18 in the speed-based group and 16 in the duration-based group completed the study. The trial measured three main things. The first was cardiovascular fitness, using a measure called VO2 peak — essentially how much oxygen the body can use during exercise, recorded in millilitres per kilogram of body weight per minute. The reported data shows that the speed-based group started at 15.9 and finished at 21.3, while the duration-based group started at 16.6 and finished at 17.5. The second measurement looked at a specific protein in the thigh muscle on the stroke-affected side (related to muscle fibre type), measured using a laboratory technique. The speed-based group went from 3.35 to 4.40 units, and the duration-based group went from 3.64 to 5.44 units. The third measure was how long participants took to walk 30 feet as quickly as they comfortably could. The speed-based group went from 15.4 seconds to 13.8 seconds, and the duration-based group went from 17.2 seconds to 15.9 seconds. It is important to note that these are simply the numbers that were recorded and reported — they describe what was observed in this particular group of participants over the course of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02667821 · results posted 12 September 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT02667821) involved 20 participants, all of whom completed the study with no drop-outs. The trial was measuring how moving the head into different positions affects blood flow and blood supply to the back part of the brain (the cerebellum and posterior cerebrum). Specialised MRI scanning techniques were used to take these measurements while participants held their heads in various positions. The reported data shows that the primary outcome — the speed of blood moving through the vertebral arteries (the blood vessels that run up through the neck to supply the back of the brain) — was measured across three head positions, recording values of 15.5, 15.1, and 14.7 centimetres per second respectively. For the secondary outcome, which measured how much blood was actually reaching and flowing through the brain tissue in the back of the brain, the reported figures across the three head positions were 79.2, 79.0, and 80.1 millilitres of blood per 100 grams of tissue per minute. An additional measure of overall blood flow volume through the vertebral arteries (rather than just speed) returned values of 1.8, 1.8, and 1.7 millilitres per second across the three positions. No further breakdown of results by individual head position was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02504073 · results posted 2 August 2017

    According to the results reported on ClinicalTrials.gov, this study involved 54 physiotherapists working with stroke patients in north-west Switzerland. All 54 participants completed the study — none dropped out. Rather than testing a treatment, this study was designed to understand how physiotherapists observe and analyse the way stroke patients walk. Each physiotherapist watched six short videos of stroke patients walking and filled in a questionnaire three times per video, answering what walking difficulties they noticed, what they thought the main problem was, and what they believed might be causing it. The reported data shows that across all the questionnaire responses, physiotherapists together identified 177 different observations about walking difficulties (referred to as "gait abnormalities"). When asked to name the single most important problem they saw, the group collectively came up with 93 different "main problems" in total. For the third question — asking for possible explanations or causes behind what they observed — the reported data shows 119 different suggestions or "hypotheses" were identified across all responses. These numbers reflect the full range of different answers given, after three independent researchers reviewed, grouped, and counted them by agreement. It is worth noting that this study was not testing whether a treatment worked — it was a survey-style study exploring the range of opinions and observations among physiotherapists. No data about patient outcomes or treatment effects was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01485354 · results posted 12 July 2017

    According to the results reported on ClinicalTrials.gov, this trial involved 17 people who had experienced a stroke and were having difficulty using one of their arms. All participants used a device called the Armeo Spring — a robotic arm support used during rehabilitation exercises — over a three-week period. The trial was measuring changes in arm movement, hand function, grip strength, and the quality of arm movements before and after the training. Of the 17 people who started, 12 completed the trial, and 5 did not complete it (no further detail on why was provided in the reported data). The reported data shows the following changes between the start and end of the three-week program. On a standard arm movement assessment (the Fugl-Meyer scale, which runs from 0 to 66, where higher is better), the average reported change was 6.4 points. For a timed functional task test (the Wolf Motor Function Test, where lower times are generally better), the average reported change was 6.6 seconds. On a movement quality rating scale (scored from 0 to 75), the average reported change was 0.3 points. A hand dexterity test — counting how many small blocks participants could move in one minute — showed an average reported change of 1.1 blocks. Finally, grip strength, measured in kilograms, showed an average reported change of 3.0 kg. These figures represent the average differences across participants who completed the assessments, and this trial had only one group, so there was no comparison group reported. No conclusions about whether these changes were meaningful or due to the device alone can be drawn from these numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01657461 · results posted 18 May 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT01657461) enrolled 196 people who had experienced a stroke — 98 in each group. One group received a clot-removal device called the Solitaire™ alongside a standard clot-dissolving drug (IV t-PA), while the other group received the clot-dissolving drug alone. The main thing the trial was measuring was the level of disability or dependence participants had 90 days later, using a standard stroke scale (called the modified Rankin Score, or mRS) that runs from 0 — meaning no symptoms at all — up to 6, meaning the person had died. The reported data shows how participants in each group were spread across those disability levels at 90 days. In the Solitaire™ plus drug group: 17 people scored 0 (no symptoms), 25 scored 1 (no significant disability), 17 scored 2 (slight disability), 12 scored 3 (moderate disability), 15 scored 4 (moderately severe disability), and 12 scored 5 (severe disability). In the drug-only group: 8 scored 0, 10 scored 1, 15 scored 2, 16 scored 3, 20 scored 4, and 24 scored 5. For secondary outcomes, the reported data shows that 9 participants in the Solitaire™ group and 12 in the drug-only group had died by 90 days. When looking at those who scored 2 or lower on the disability scale (described in the trial as "functional independence"), 59 participants were in that range in the Solitaire™ group compared with 33 in the drug-only group. The reported data also shows changes on a separate neurological assessment (the NIH Stroke Scale, scored 0–42, where higher means more impairment): scores changed by an average of −8.5 points in the Solitaire™ group and −3.9 points in the drug-only group from the start to around 27 hours later. The reported volume of brain tissue affected at that same time point was 60.2 cc in the Solitaire™ group and 65.9 cc in the drug-only group. A measure of blood flow restoration (reperfusion ratio) was reported as 81 in the Solitaire™ group and 61.9 in the drug-only group; however, what specific units or scale this ratio uses was not fully described in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02513095 · results posted 9 May 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT02513095) enrolled 34 people in total — 17 in the active treatment group (who received Ryanodex plus standard of care) and 17 in the control group (who received standard of care alone). All 34 participants completed the study. The trial was looking at a specific measure of consciousness called the Glasgow Coma Scale (GCS), which is a standard scoring system used to assess how alert and responsive a person is, with scores ranging from 3 (least responsive) to 15 (fully alert). The main question the trial was measuring was how many people in each group reached a GCS score of 13 or higher — meaning mild or no impairment of consciousness — within 90 minutes of being enrolled. The reported data shows that, out of 17 people in the active treatment group, 5 reached a GCS score of 13 or above within that 90-minute window. In the control group, 2 out of 17 people reached the same score within the same timeframe. No other outcome measures were included in the structured data submitted to ClinicalTrials.gov, so further details about other aspects of the trial are not available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01778855 · results posted 13 April 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT01778855) enrolled a very small number of participants — 2 people in the "Normothermia" group (normal body temperature) and 4 people in the "Hypothermia" group (cooled body temperature), for a total of 6 participants. The trial was looking at whether cooling the body affects how well a clot-dissolving treatment called tPA opens blocked arteries in people who had experienced an acute ischaemic stroke (a stroke caused by a blood clot). Blood vessel opening was measured using a scoring system called the TIMI score, which rates how well blood is flowing through an artery, compared before treatment and again at 36 hours. The reported data shows that, of those who started the trial, 2 participants in the Normothermia group and 3 participants in the Hypothermia group were counted in the primary outcome measure of recanalization (artery opening). One participant in the Hypothermia group did not complete the trial. The results data notes that additional data needed for further (secondary) analyses were not collected, so those analyses could not be carried out. No further outcome numbers beyond participant counts were reported for this measure. It is worth noting that with only 6 participants in total, this was an extremely small study. The reported data shows participant numbers only — no conclusions about whether one approach performed better than the other can be drawn from what was submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02017574 · results posted 10 February 2017

    According to the results reported on ClinicalTrials.gov, this trial involved 24 adults in total — 12 in an "Implicit Group" and 12 in a "Control Group" — and all 24 completed the study with no dropouts. The trial was looking at motor learning, specifically how well participants could move along a set pathway (a curved, half-circle-shaped channel about 2 cm wide between two points 25 cm apart). It also measured brain activity using EEG (a method that records electrical signals from the scalp) to examine attention during the task. The reported data shows that, for the main outcome — the percentage of time participants' movements were *off* the target pathway — the Implicit Group recorded a figure of 0.49% and the Control Group recorded 0.67%. For the secondary outcome, which measured a specific type of brain wave activity (called "high alpha power," linked to attention) as a proportion of total brain wave activity recorded, the Implicit Group showed a value of 0.089 and the Control Group showed 0.086. These numbers are reported as proportions of the total brain activity measured. It is worth noting that the reported figures are very close together across both groups for both outcomes, though the trial's design and whether any formal comparison was made between the groups is not detailed in the submitted results data. No further breakdown of what these specific numbers mean in a clinical sense was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00647998 · results posted 2 January 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT00647998) enrolled 18 people in total — 9 received a medication called Darbepoetin Alfa, and 9 received standard care. All 18 participants completed the study. The trial was looking at a combined outcome of death or significant neurological disability, measured using two scoring tools: one that assesses stroke severity (the NIHSS, where a score above 4 suggests moderate to severe impairment) and one that assesses leg muscle strength and ability to walk (the ASIA Lower Extremity Motor Score, where a score below 25 suggests difficulty with walking). The reported data shows that, for the primary outcome — death or significant neurological disability — 1 out of 9 participants in the Darbepoetin Alfa group met this outcome, compared with 3 out of 9 in the standard care group. For the secondary outcomes, the reported data shows that a protein measured in spinal fluid called S100beta (which can be a marker of nervous system injury) was recorded at an average of 214 pg/mL in the Darbepoetin Alfa group and 260 pg/mL in the standard care group. Haemoglobin levels (a measure of red blood cells in the blood) were reported as an average of 10.4 gm/dL in the Darbepoetin Alfa group and 9.5 gm/dL in the standard care group. No further breakdown of these figures (such as ranges or timing of measurements) was reported in the submitted data. It is worth noting that this was a very small study with only 9 people in each group, and the results as submitted do not include additional context such as whether the differences between groups were considered statistically meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00227994 · results posted 28 December 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 40 people in total — 20 in a group taking galantamine and 20 in a group taking donepezil. Both medications are used in the context of memory and thinking difficulties. The trial was comparing the two groups on physical function and how well participants tolerated each medication. Physical function was measured using a tool called the FIM-motor scale, which runs from 7 (meaning a person needs complete assistance with physical tasks) to 91 (meaning a person is fully independent). The reported data shows that, at the start, the galantamine group had an average score of 47.1 and the donepezil group had an average score of 49.4. At a later point in the trial, the galantamine group's average score was reported as 73.1, while the donepezil group's average score was reported as 87.4. The reported data also shows that 13 out of 20 participants completed the trial in each group, meaning 7 people in each group did not finish. For the secondary outcome looking at tolerability, the reported data shows that 5 participants in the galantamine group and 5 participants in the donepezil group withdrew from the trial due to side effects. It is worth noting that the trial was relatively small, and some details — such as the exact timing of the follow-up measurements — were not fully specified in the data reported to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00091949 · results posted 28 October 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 3,876 people in total — 1,939 received pioglitazone (a diabetes-related medication) and 1,937 received a placebo (a dummy treatment with no active ingredient). The trial was designed for people who had already had a stroke and were found to have insulin resistance (meaning their bodies were not responding normally to insulin, but they had not yet been diagnosed with diabetes). The main thing the trial was measuring was whether participants went on to have another stroke or a heart attack — either fatal or non-fatal — during the study period. A number of secondary (additional) outcomes were also tracked, including stroke alone, heart-related events, development of diabetes, deaths from any cause, and changes in mental thinking ability. The reported data shows that for the primary outcome — a second stroke or heart attack — 175 participants in the pioglitazone group and 228 in the placebo group experienced one of these events. For the additional outcomes: stroke alone occurred in 127 pioglitazone participants versus 154 placebo participants; heart-related events (heart attack or unstable angina) occurred in 206 versus 249 participants respectively; development of diabetes was recorded in 73 pioglitazone participants compared with 149 placebo participants; and deaths from any cause numbered 136 in the pioglitazone group versus 146 in the placebo group. For the thinking and memory test (scored on a scale of 0–100), the reported average change from the start of the trial to the end was 0.27 points in the pioglitazone group and 0.29 points in the placebo group — both very small changes on that scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01997905 · results posted 21 October 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 13 participants, all of whom received a device called the AtriClip LAA Exclusion Device. This is a small clip placed around a part of the heart called the left atrial appendage (a small pouch in the heart often associated with blood clot formation in people with an irregular heartbeat). The trial was measuring two main things: whether any serious unwanted events occurred within 30 days of the procedure, and whether the device was successfully placed and fully closed off that heart pouch. Eleven participants completed the baseline (starting) stage, and 10 completed the full study. The reported data shows that, for the first primary measure, zero out of 13 participants experienced a serious adverse event (an unexpected harmful event) within 30 days of the procedure. For the second primary measure — whether the device was successfully placed and the heart pouch fully closed off both during the procedure and at a follow-up check around three months later — 8 out of the participants who reached that stage met all the required criteria for success. For the secondary measures, the reported data shows zero participants experienced a stroke or a blood clot travelling elsewhere in the body within the follow-up period, and zero participants had a serious adverse event judged to be directly related to the device or procedure. The reported data also shows that several adverse events of varying types were recorded across participants over the follow-up period, though the detailed breakdown across individual event categories contains multiple separate figures. It is worth noting that, given the very small number of participants in this trial, these numbers represent a limited snapshot only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01122394 · results posted 20 October 2016

    According to the results reported on ClinicalTrials.gov, this trial involved 140 people in total — 66 in a group called the "Tailored Intervention" (TI) and 74 in a group called the "Attention Placebo" (AP). Most participants completed the trial: 63 from the TI group and 70 from the AP group. The trial was measuring several things related to heart health and lifestyle habits, including blood pressure, cholesterol levels, physical activity, diet, and how consistently participants took their medications. The reported data shows that for the main outcome — systolic blood pressure (the top number in a blood pressure reading, measuring the pressure in blood vessels when the heart beats) — the TI group had an average reading of 130.83 mmHg, while the AP group had an average of 133.67 mmHg. For cholesterol, the TI group had a total cholesterol-to-HDL ratio of 3.47, compared to 3.21 in the AP group. For physical activity, the TI group reported an average of 2.50 hours per week of cardio exercise and the AP group reported 2.75 hours per week. For medication-taking (scored on a scale of 0 to 4, where 4 means most consistent), the TI group scored 3.58 and the AP group scored 3.43. The reported data also shows that for diet, participants were grouped by their self-reported stage of readiness to follow a low-sodium diet. In the TI group, 11 participants were recorded in the earlier stages (not yet following the diet) and 52 in the later stages (actively following or maintaining the diet). In the AP group, 18 were in the earlier stages and 52 were in the later stages. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00362414 · results posted 29 August 2016

    According to the results reported on ClinicalTrials.gov, this trial looked at a combination treatment involving two growth factors — beta-hCG and erythropoietin — given to people who had experienced a stroke. Fifteen people were enrolled in the single treatment group, and 12 of them completed the study. The trial was primarily measuring whether the treatment caused any harm, and secondarily measuring arm and leg movement ability using standard scoring tools. The reported data shows that, for the three primary measures — safety events, illness linked to the treatment, and deaths linked to the treatment — the number of participants who experienced these was reported as zero across all three measures. For the secondary movement measures, the reported average scores were: 23 out of a possible 57 on the Action Research Arm Test (which assesses hand and arm movements), 32 out of a possible 66 on the Fugl-Meyer Arm Scale (which measures upper body movement), and 20 out of a possible 34 on the Fugl-Meyer Leg Scale (which measures leg movement). In all three scales, a higher number represents better movement ability. It is important to note that there was no comparison group in this trial, so these scores reflect where participants sat on the scales at the end of the study period only, with no before-and-after comparison data reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00983749 · results posted 28 June 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 23 people in total — 13 in a "full-pressure" group receiving External Counterpulsation (ECP, a procedure where inflatable cuffs on the legs are used to try to improve blood flow) and 10 in a "sham-pressure" group who received a low-pressure version intended as a comparison. The trial was measuring two things: firstly, whether the procedure was practical to carry out and could be tolerated by stroke patients; and secondly, whether certain safety-related events occurred, such as worsening stroke symptoms, new bleeding in the brain, serious adverse events linked to the device, or death within 30 days. The reported data shows that, for the tolerability and feasibility outcome, 12 out of 13 participants in the full-pressure group and 9 out of 10 in the sham-pressure group met the criteria set out by the researchers. For the safety outcomes, the reported data shows that zero participants in either group experienced acute neurological deterioration (a meaningful worsening of stroke symptoms), zero experienced new bleeding on brain scans, zero experienced serious adverse events considered related to the device or procedures, and zero died within 30 days. In the follow-up phase through to 30 days, 1 person in the full-pressure group and 3 in the sham-pressure group did not complete that phase, though the reasons for this are not detailed in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00400712 · results posted 5 May 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 103 people — 52 in the control group and 51 in the intervention group. Of those, 35 people in each group completed the study (17 control participants and 16 intervention participants did not finish). The trial was measuring how well stroke survivors reintegrated into daily physical and social life, using a questionnaire called the SIPSO (scored out of 40, where higher means better reintegration). It also measured mobility, walking distance, and self-reported quality of life. The reported data shows that on the main SIPSO measure (out of 40), the control group scored an average of 26.6 at the start and 29.7 at the end, while the intervention group scored 26.8 at the start and 30.1 at the end. For the social integration part of that same questionnaire (scored out of 20), the control group went from 13.8 to 14.4, and the intervention group went from 14.0 to 14.7. On the mobility test — where participants stood up, walked 3 metres and sat back down — the control group averaged 23.1 seconds at the start and 18.7 seconds at the end, while the intervention group averaged 19.9 seconds at the start and 19.7 seconds at the end. For the 6-minute walking test, the control group went from an average of 258.9 metres to 332.0 metres, and the intervention group went from 285.1 metres to 338.1 metres. The reported data also shows scores from a quality-of-life survey (the SF-36, scored out of 100). For physical health, the control group went from 35.7 to 42.0 points and the intervention group from 36.4 to 40.3 points. For mental health, the control group went from 48.0 to 52.8 points and the intervention group from 49.3 to 51.2 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00871715 · results posted 27 April 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 361 people who had experienced a stroke and were having difficulty using one of their arms or hands. Participants were randomly placed into one of three groups: an intensive program called ASAP (119 people), a dose-matched version of standard care called DEUCC (120 people), or regular standard care called UCC (122 people). The trial measured changes in arm and hand function over 12 months, looking at how quickly and how well participants could complete a set of standardised arm tasks (the Wolf Motor Function Test), as well as how participants themselves rated their hand function and mobility (the Stroke Impact Scale). The reported data shows that across all three groups, participants took less time to complete the arm tasks by the end of the study. The ASAP group showed an average reduction of about 8.1 seconds per task, the DEUCC group about 8.7 seconds, and the UCC group about 7.5 seconds. For the self-rated hand function score (on a scale of 0–100, where higher is better), all three groups reported improvements of around 35–38 points on average. When looking at how many participants improved their hand function score by at least 25 points, the reported figures were approximately 73% in the ASAP group, 72% in the DEUCC group, and 69% in the UCC group. For self-rated mobility, the reported average improvements were around 11 points for ASAP, 12 points for DEUCC, and 15 points for UCC. One secondary outcome — a measure of movement quality during the arm tasks — was listed but no results data was reported for it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01134887 · results posted 14 April 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 30 participants across four groups. There were 9 veterans in the intervention group and 11 in the control group, plus 5 physicians in each of the intervention and control groups. All veterans in the intervention group and all physicians in both groups completed the study, while 4 veterans in the control group did not finish. The trial was measuring how actively veterans managed their own high blood pressure (hypertension) over a 12-month period, using a standardised questionnaire called the Patient Activation Measure (PAM) — a scoring tool that runs from 0 to 100, where higher scores indicate a person is more engaged in looking after their own health. The reported data shows that, at the start of the study (baseline), the average PAM score for veterans in the intervention group was 61.33, and for veterans in the control group it was 60.86 — meaning both groups started at a similar level. After up to 12 months of follow-up, the reported average score for the intervention group had risen to 63.49, while the control group's average score had fallen to 57.45. In plain terms, the intervention group's score went up by roughly 2 points from where they started, while the control group's score went down by roughly 3 points. Outcome data for the physician groups was not reported for this particular measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01445613 · results posted 12 April 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 1,200 people who received a carotid artery stent procedure using a device called the RX Acculink Carotid Stent System. The stent is placed in the carotid artery (the main artery in the neck that supplies blood to the brain) to treat narrowing of that artery. The trial followed participants for up to one year. By the 30-day mark, 1,165 people had completed that stage of follow-up, and 1,088 completed the full one-year follow-up. The reported data shows the main thing being measured was a combined rate of death and stroke — both in the first 30 days after the procedure, and any stroke on the same side of the brain as the treated artery between day 31 and one year. According to the results reported on ClinicalTrials.gov, 4.4% of participants experienced this combined outcome, while 95.6% were free from it over the year. For death and stroke of any kind within 30 days, the reported figure was 3.4% of participants. The reported data also shows a breakdown by whether participants had previous stroke or related symptoms before the procedure: the combined 30-day rate of death and stroke was reported as 5.8% in those who had prior symptoms, compared with 2.5% in those who had not. The one-year freedom-from-event rate was reported as 92.5% for the symptomatic group and 96.8% for the asymptomatic group. Interestingly, the reported 30-day combined rate of death and stroke was the same — 3.4% — whether participants were aged in their eighties or younger. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01370083 · results posted 30 December 2015

    According to the results reported on ClinicalTrials.gov, this trial involved people who had experienced a stroke and were having difficulty swallowing. A total of 14 participants took part — 7 in each group. One group received a treatment called TPPT (Tongue Pressure Profile Training) and the other received a control treatment called TPSAT. The trial was measuring things related to swallowing, including how quickly the throat responds during a swallow, whether food or liquid entered the airway, and tongue muscle pressure. The reported data shows the following numbers for the main measure — swallow response time, which tracks how fast the throat begins to protect the airway during swallowing (a response time over 350 milliseconds is considered a sign of impairment). At the end of the study, 4 out of 5 participants who completed the TPPT group, and 3 out of 6 who completed the control group, had a response time under 350 milliseconds. For the first secondary measure — whether material entered the airway during swallowing — 4 out of 5 in the TPPT group and 1 out of 6 in the control group scored above the threshold considered a concern. For the second secondary measure — tongue muscle pressure, measured in kilopascals — the TPPT group recorded an average of 28.45 kilopascals, while the control group recorded 43.84 kilopascals. It is worth noting that not all participants who started the trial completed it, and the overall numbers involved were very small. The reported data does not include additional detail about how the groups compared statistically, and with such small participant numbers, the figures should be interpreted with caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01977456 · results posted 25 November 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT01977456) enrolled 27 participants, all of whom received a medication called eptifibatide. Twenty-two participants completed the study, while five did not. The trial was looking at what happened to people's brains after receiving this treatment — specifically, whether they developed bleeding in the brain (known as intracerebral haemorrhage, or ICH), either with or without noticeable symptoms. The reported data shows that, for the primary outcome — bleeding in the brain that caused noticeable neurological symptoms — 1 out of 27 participants experienced this. For the secondary outcomes, 2 participants experienced any brain bleeding (whether they had symptoms or not), and 1 participant developed a specific type of bleeding in the brain tissue (called parenchymal haemorrhage). In a separate pre-specified measure using a disability scale called the modified Rankin Score — where a "good outcome" meant little to no disability or a return to how the person functioned before — 17 out of 27 participants were reported as having a good outcome at follow-up. It is worth noting that this was a small study with 27 participants, so the numbers reported reflect a limited group of people. The reported data shows what was observed and measured in this specific trial; it does not on its own establish whether the treatment works or is safe more broadly. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00984308 · results posted 1 September 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 225 people in total — 110 in the intervention group and 115 in the control group. By the end of the study, 92 people in the intervention group and 109 in the control group had completed it. The trial was measuring two main things: how many participants were diagnosed with sleep apnea, and what their blood pressure readings were (adjusted to account for any blood pressure medications they were taking). A secondary measure looked at how many participants went on to receive treatment for sleep apnea. The reported data shows that 58 out of 110 people in the intervention group were diagnosed with sleep apnea, compared to just 5 out of 115 people in the control group. For blood pressure, the intervention group had an average reading of 157.4 mmHg (millimetres of mercury — the standard unit for measuring blood pressure), while the control group averaged 161.6 mmHg. Regarding the secondary outcome, 22 people in the intervention group went on to receive sleep apnea treatment, compared to none (0) in the control group. It is worth noting that the reported data does not include further detail explaining the large difference in sleep apnea diagnosis rates between the two groups, so no conclusions about why this occurred can be drawn from the numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01344447 · results posted 26 August 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 479 participants, all of whom received a contrast agent called gadobutrol (also known as Gadavist or BAY 86-4875) as part of a specialised type of blood vessel scan called MRI angiography (MRA). The trial was measuring how well this contrast-enhanced scan could show the arteries in the neck and head area compared to an MRI scan done without any contrast agent. The reference standard used to check accuracy was a different type of scan called CT angiography (CTA). A total of 471 participants completed the study, and 457 were included in the main analysis group. The reported data shows that when it came to how much of each blood vessel could be clearly seen and measured, the contrast-enhanced MRI produced assessable images of around 95–97% of vessel sections, depending on which reader reviewed the images. By comparison, the unenhanced MRI produced assessable images of roughly 24–83% of vessel sections. When looking at how often the scans correctly identified a significant narrowing (70–99%) in a vessel — a measure called "sensitivity" — the contrast-enhanced MRI returned figures of approximately 58–61%, while the unenhanced MRI returned figures of approximately 39–56%. For how often the scans correctly ruled out a significant narrowing — a measure called "specificity" — the contrast-enhanced MRI returned figures of approximately 92–98%, compared to approximately 62–89% for the unenhanced MRI. The reported data also shows that vessel diameter measurements at normal and narrowed points were broadly similar across the three scanning methods, ranging from roughly 2.3 mm to 5.2 mm depending on the method and the point measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00059332 · results posted 21 August 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 1,700 people who had experienced a stroke — 843 were assigned to receive normal saline (a saltwater solution used as a comparison) and 857 were assigned to receive magnesium sulfate. The trial was measuring how well people recovered from their stroke across several areas, including overall disability, ability to carry out daily activities, neurological function, and quality of life. Nearly all participants — 840 in the saline group and 855 in the magnesium sulfate group — completed the study. The reported data shows that on the primary measure of recovery — the Modified Rankin Scale, a disability rating that runs from 0 (no symptoms) to 6 (death) — both groups had a median score of 2, which on that scale means "slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance." For the secondary measures, the reported data shows similar numbers between the two groups across the board. The number of participants with minimal or no disability (a score of 0 or 1 on that same scale) was 311 in the saline group and 313 in the magnesium sulfate group. The number able to function independently (score of 2 or below) was 445 versus 449. Scores on the neurological deficit scale were the same (3 out of 42) in both groups. The daily activities score (out of 100, higher is better) was 95 for the saline group and 90 for the magnesium sulfate group, and the stroke-specific quality-of-life score was 65 versus 67 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00129545 · results posted 15 May 2015

    According to the results reported on ClinicalTrials.gov, this trial involved three groups of participants: a "roll-in" group of 93 people (used to help train the implanting doctors), 463 people who received a small implantable device called the WATCHMAN (designed to block off a small pouch in the heart called the left atrial appendage), and 244 people who continued taking warfarin, a blood-thinning medication. The trial was measuring whether the WATCHMAN device could be compared to warfarin in people with a heart rhythm condition called atrial fibrillation. It tracked serious events including stroke, clots travelling to other parts of the body, and cardiovascular or unexplained death, as well as serious bleeding or safety-related events. The reported data shows that for the main measure — a combined count of strokes, travelling clots, and cardiovascular or unexplained deaths — the WATCHMAN group had a reported rate of 2.2 events per 100 patient-years, while the warfarin group had a reported rate of 3.7 events per 100 patient-years. ("Events per 100 patient-years" is simply a way of counting how often something happened, adjusted for how long people were followed.) For the second primary measure — serious or life-threatening events such as significant bleeding, device movement out of place, or procedure-related complications requiring surgery — the reported rate was 3.5 events per 100 patient-years in the WATCHMAN group and 3.2 events per 100 patient-years in the warfarin group. As a secondary measure, the reported data shows that the WATCHMAN device was successfully implanted in approximately 90.9% of attempts. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00781391 · results posted 25 March 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT00781391) enrolled just over 21,000 people across three groups — roughly 7,035 participants in each group. One group took warfarin (a well-known blood-thinning medicine) with a placebo standing in for the study drug, while the other two groups took either a higher or lower dose of edoxaban (the medicine being studied) with a placebo standing in for warfarin. The trial was measuring how often participants experienced a stroke or a "systemic embolic event" (meaning a blood clot travelling to another part of the body) — comparing those outcomes between the edoxaban groups and the warfarin group. The reported data shows the following numbers of participants who experienced a stroke or systemic embolic event. Looking at the full study period across all enrolled participants: 383 people in the low-dose edoxaban group, 296 in the high-dose edoxaban group, and 337 in the warfarin group had one of these events. When the researchers looked only at events that happened while participants were actively taking their assigned medicine, the numbers were 253 (low-dose edoxaban), 182 (high-dose edoxaban), and 232 (warfarin). For a broader combined measure that also included deaths from heart or blood vessel causes, the reported data shows 796 events in the low-dose edoxaban group, 728 in the high-dose edoxaban group, and 831 in the warfarin group over the full study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00932425 · results posted 27 February 2015

    According to the results reported on ClinicalTrials.gov, this trial involved 40 people in total — 20 in an outpatient cardiac monitoring group and 20 in a control group. The trial was a feasibility study, meaning it was designed to test whether a larger, full-scale trial could be run smoothly, rather than to draw firm conclusions about treatment. Specifically, it looked at whether enough participants could complete their follow-up appointments and, for those in the monitoring group, whether they could complete a 21-day heart monitoring program using a wearable device. The reported data shows that all 20 participants in the monitoring group and 18 out of 20 in the control group completed the study's clinical follow-up. Regarding completion of the heart monitor wear, the reported data shows that 15 out of 20 participants in the monitoring group finished the full 21-day monitoring period. For the secondary outcomes, the reported data shows that no participants in either group were diagnosed with atrial fibrillation (an irregular heartbeat) during the study. For recurrent stroke or TIA (a brief, stroke-like episode), the numbers reported across follow-up time points show 0 events in the monitoring group and 1 in the control group at one time point, and 1 event in the monitoring group and 2 in the control group at another time point. It is worth noting that because this was a small feasibility study, the numbers involved are very limited. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01347580 · results posted 11 February 2015

    According to the results reported on ClinicalTrials.gov, this trial (NCT01347580) enrolled 909 people in the "pre-hospital ticagrelor" group and 953 people in the "in-hospital ticagrelor" group — a total of 1,862 participants. The trial was comparing two timing approaches for giving a blood-thinning medication called ticagrelor to people having a serious type of heart attack: one group received it before arriving at hospital, and the other received it once they were already in hospital. The trial measured blood flow in the blocked heart artery and changes in heart electrical activity (recorded on a heart tracing, or ECG) before a procedure to open the artery, as well as a number of other clinical events afterwards. The reported data shows that for the first main measurement — whether full blood flow was restored in the blocked artery before the procedure — 143 people in the pre-hospital group and 145 people in the in-hospital group had this recorded. For the second main measurement — whether the heart tracing showed a significant improvement (of 70% or more) before the procedure — 102 people in each group met that threshold. For the secondary outcomes, the reported data shows that a combined measure of serious events (death, heart attack, stroke, urgent re-opening of a blocked artery, or a clot forming in a stent) occurred in 41 people in the pre-hospital group and 42 in the in-hospital group. A second combined measure (death, heart attack, or urgent re-opening of a blocked artery) was recorded in 39 and 34 people respectively. Confirmed clots forming in a stent were recorded in 2 people in the pre-hospital group and 11 in the in-hospital group. Full blood flow after the procedure was recorded in 625 and 630 people respectively. The total numbers used to calculate rates across outcomes varied slightly, as the data was not reported as percentages for all measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00252239 · results posted 19 January 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 112 people who had experienced a stroke. Participants were divided into four groups and given one of three different doses of a clot-dissolving drug called TNK (tenecteplase) — either 0.1 mg/kg, 0.25 mg/kg, or 0.4 mg/kg — or a standard clot-dissolving treatment called tPA at 0.9 mg/kg. The trial was measuring functional outcome (that is, how much difficulty participants had with day-to-day activities) three months after treatment, using a well-known stroke disability scale called the Modified Rankin Score. The reported data shows that the primary outcome measured the percentage of participants in each group who scored 4 or higher on the Modified Rankin Score — a score of 4 or above on this scale (which runs from 0, meaning no symptoms, to 6, meaning death) indicates significant disability or worse. According to the results reported on ClinicalTrials.gov, in the lowest TNK dose group (0.1 mg/kg), 22.6% of participants scored 4 or above. In the middle TNK dose group (0.25 mg/kg), 35.5% scored 4 or above. In the highest TNK dose group (0.4 mg/kg), 31.6% scored 4 or above. In the tPA comparison group, 32.3% scored 4 or above. No secondary outcome measure data was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00384748 · results posted 10 November 2014

    According to the results reported on ClinicalTrials.gov, this trial involved 48 people split across two groups — 25 people in Arm 1 and 23 people in Arm 2. All 48 participants completed the study, with no one dropping out. The trial was measuring physical function using a telephone-based assessment tool called the FONEFIM (a phone version of a standard independence questionnaire). This tool looks at 13 everyday tasks — such as self-care, bladder and bowel control, moving around, and getting from place to place — and gives each task a score from 1 (fully dependent on others) to 7 (fully independent), for a total possible score anywhere between 13 and 91. A higher score means a greater level of independence in day-to-day physical tasks. The reported data shows that at the end of the study, Arm 1 recorded an average score of 83.7 out of 91 on this physical function scale, while Arm 2 recorded an average score of 80.9 out of 91. Both scores sit towards the higher end of the scale. No secondary outcome measures appear to have been reported in the data submitted to ClinicalTrials.gov, so no further comparisons can be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00106938 · results posted 21 October 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT00106938) enrolled a total of 1,453 people across two groups: 1,089 people in the CAS group (carotid artery stenting, a procedure using a small mesh tube to open a narrowed artery in the neck) and 364 people in the CEA group (carotid endarterectomy, a surgical procedure to clear the same artery). The trial was measuring and comparing rates of serious events — including death, stroke, and heart attack — in the 30 days after the procedure, as well as stroke on the treated side of the brain between 31 and 365 days later. The reported data shows that for the main outcome — a combined measure of death, stroke, or heart attack within 30 days, plus stroke on the treated side between one month and one year — 3.8% of participants in the CAS group and 3.4% of participants in the CEA group experienced one or more of these events. For the stenting group only, the reported data shows that the stent device was successfully placed as intended in 96.9% of cases, and the embolic protection device (a small filter used during the procedure to catch any debris) was successfully used in 97.8% of cases. Overall procedural success in the CAS group was reported at 95.6%. For a secondary measure looking at freedom from needing a repeat procedure on the same area, 99.8% of the CAS group and 99.7% of the CEA group did not require one. The reported data also tracked a range of other complications at 30 days — such as nerve injury, bleeding, wound issues, and anaesthetic-related problems — with some individual counts reported for each group, though the breakdown across all sub-categories was not fully detailed in the submitted data. The one-year freedom-from-repeat-procedure figures were similar between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01562613 · results posted 30 July 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 533 adults with high blood pressure (hypertension) in Greece, and 529 of them completed the six-month study. The trial was measuring two main things: how many participants reached a target blood pressure level (as defined by European heart and blood pressure guidelines) after taking a blood pressure medicine called eprosartan for six months, and by how much their top blood pressure number (systolic blood pressure) changed over that time. The reported data shows that 62.8% of participants reached the target blood pressure levels set out in the guidelines after six months of treatment. The reported data also shows that, on average, participants' systolic (top number) blood pressure reading fell by 31.1 mmHg from where it started at the beginning of the trial. As a secondary measure, the trial tracked changes in something called the Framingham Stroke Risk Profile score — a tool used to estimate a person's likelihood of having a stroke within 10 years, based on factors like age, blood pressure, and certain health conditions. The reported data shows the group's average score on this scale changed from 14 at the start to 11 at the end of the study period, representing a reduction in the calculated score. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01735877 · results posted 30 June 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 48 people in total — 27 in the Mirror Therapy group and 21 in a Control Group. Nearly all participants completed the study (26 from the Mirror Therapy group and all 21 from the Control Group). The trial was looking at a condition called "unilateral visual neglect" — a problem that can occur after a stroke where a person has difficulty noticing things on one side of their vision. Three main tests were used to track any changes over time: a Star Cancellation Test (crossing out small stars on a page, scored out of 54), a Line Bisection Test (marking the centre of a line, measured in centimetres of error), and a Picture Identification Task (identifying pictures out of 10). These were measured at the start of the trial and again at 1, 3, and 6 months. The reported data shows the following changes from the starting point. On the Star Cancellation Test (where higher scores are better), the Mirror Therapy group's average change scores were 20.03, 31.76, and 34.88 at 1, 3, and 6 months respectively, compared to 5.90, 9.20, and 11.60 for the Control Group. On the Line Bisection Test (where a larger number reflects a bigger shift away from the true centre), the Mirror Therapy group's average changes were 10.42, 18.26, and 19.03 centimetres at 1, 3, and 6 months, compared to 4.50, 9.55, and 10.40 for the Control Group. On the Picture Identification Task (more pictures identified suggests less neglect), the Mirror Therapy group's average changes were 4.88, 5.16, and 5.16 pictures at 1, 3, and 6 months, compared to 1.20, 1.75, and 1.95 for the Control Group. For the two secondary measures — a disability scale (Modified Rankin Scale) and a functional independence measure — the reported data shows participant counts across categories, but detailed breakdowns within those categories were not fully reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00894803 · results posted 17 March 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 126 people who had experienced a stroke. One hundred and one participants received a combination of two clot-dissolving or clot-targeting medicines — rt-PA (a standard clot-dissolving drug) and eptifibatide (a drug that affects how platelets, the tiny blood cells involved in clotting, behave) — while 25 participants received rt-PA alone. The trial was measuring two main things: how often a serious type of bleeding inside the brain (called symptomatic intracranial haemorrhage) occurred within 36 hours, and how well participants were functioning 90 days later, using a standard stroke disability scale called the Modified Rankin Scale (a 0–6 score where lower numbers mean less disability). The reported data shows that, for the primary brain bleeding outcome within 36 hours, 2 out of 101 people in the combination group experienced this type of bleeding, compared with 3 out of 25 in the rt-PA only group. For the functioning outcome at 90 days, 50 out of 101 people in the combination group scored at a level indicating little or no disability (a score of 0 or 1, or back to their pre-stroke level), compared with 9 out of 25 in the rt-PA only group. The reported data also shows that, among additional pre-specified outcomes, asymptomatic brain bleeding (bleeding that did not cause new symptoms) within 7 days was recorded in 16 out of 101 participants in the combination group versus 3 out of 25 in the rt-PA only group. Deaths within 7 days were reported as 12 out of 101 in the combination group and 3 out of 25 in the rt-PA only group. One participant in the combination group required a blood transfusion for serious systemic bleeding, compared with none in the rt-PA only group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00995774 · results posted 14 February 2014

    According to the results reported on ClinicalTrials.gov, this trial involved 12 people in total — split into two groups of 7 and 5. It used a "crossover" design, meaning both groups eventually tried both types of arm training: one that used a robotic device and one that used conventional (standard) therapy. The trial was measuring changes in arm movement and function after each type of training, using two standard scoring tools that assess how well someone can move and use their arm after a stroke or similar condition. The reported data shows the following changes in scores on the Fugl-Meyer Test, which measures arm movement on a scale of 0 to 66 (where 66 means no movement problems). The group that did robotic training first showed a reported change of 1.9 points after their first training period, 1.3 points after their second period, and 1.6 points overall. The group that did conventional training first showed reported changes of 0.8, 0.8, and 1.6 points across the same time points. For the second measure — the Action Research Arm Test, which looks at how well someone can use their arm in everyday tasks on a scale of 0 to 57 — the reported changes ranged from −2 to 4.6 points across the two groups and time periods. A third measure involving motion-tracking technology was listed, but no numerical results were reported in the submitted data. It is also worth noting that 2 participants from the "Robotic Then Conventional" group did not complete the second training period, while all 5 in the other group did. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00359424 · results posted 13 December 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 656 people who had experienced a stroke — 434 in the endovascular therapy group (a catheter-based treatment delivered directly to the blocked blood vessel) and 222 in the intravenous clot-busting drug (IV rt-PA) alone group. The trial was measuring things like how well participants were able to function independently after 90 days, whether they died, and whether they experienced bleeding in the brain. Not all participants completed the full follow-up period: 304 in the endovascular group and 155 in the IV rt-PA group finished the study. The reported data shows that for the main measure of functional independence — scored on a scale called the modified Rankin Scale, where a score of 0–2 means a person can largely look after themselves — 177 participants in the endovascular group and 86 in the IV rt-PA group scored in that independent range, while 257 and 136 respectively scored above 2, meaning greater levels of difficulty or disability. The reported data also shows that 83 deaths occurred in the endovascular group and 48 in the IV rt-PA group. For bleeding inside the brain with worsening symptoms, 27 cases were reported in the endovascular group and 13 in the IV rt-PA group. For bleeding without worsening symptoms, 119 were reported in the endovascular group and 42 in the IV rt-PA group. Looking at the secondary measures, the reported data shows that a type of serious blood clot in the brain tissue (called a PH2 hematoma) was recorded in 25 participants in the endovascular group and 13 in the IV rt-PA group. On a separate neurological deficit scale (NIHSS, where lower scores mean less deficit), 44 participants in the endovascular group and 22 in the IV rt-PA group scored in the near-normal range (0–1), while 390 and 200 respectively scored 2 or above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01429077 · results posted 28 November 2013

    According to the results reported on ClinicalTrials.gov, this trial involved 36 people in total — 19 who received a medication called Levodopa (combined with Carbidopa) and 17 who received an inactive pill (sometimes called a placebo). All 36 participants started and completed the six-week treatment phase, though three people in the inactive pill group did not finish the full study. The trial was measuring changes in language ability in people with aphasia (a condition affecting communication, often after a stroke or brain injury), using a tool called the Western Aphasia Battery, which gives a "Language Quotient" score on a scale from 0 to 100, where a higher score means better language ability. The reported data shows that both groups showed some improvement in their Language Quotient scores over the six-week period. The Levodopa group had an average improvement (change from their starting score) of 3.16 points, while the inactive pill group had an average improvement of 2.59 points. These are the change scores — that is, how much each group's average score shifted from the beginning to the end of the six weeks — not the total scores themselves. For the secondary outcome measures — which included things like functional communication skills, participation in everyday activities, reading and writing scores, and longer-term maintenance of language ability — the reported data shows that no numerical results were submitted to ClinicalTrials.gov, so those figures are not available to describe here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00496769 · results posted 14 November 2013

    According to the results reported on ClinicalTrials.gov, this trial (NCT00496769) enrolled a total of 5,598 people in its main double-blind phase — 2,807 assigned to apixaban (a blood-thinning tablet taken twice daily) and 2,791 assigned to acetylsalicylic acid, commonly known as aspirin (taken once daily). A separate open-label phase also included 3,275 participants who all received apixaban. The trial was measuring rates of serious events — such as stroke, clots travelling to other parts of the body (systemic embolism), heart attack, and death — in people with a type of irregular heartbeat called atrial fibrillation. The study was stopped earlier than originally planned after a pre-set review found a notable difference between the two groups. The reported data shows that for the primary outcome — stroke or systemic embolism — the event rate was 1.62% in the apixaban group and 3.63% in the aspirin group over the intended treatment period. For a broader combined outcome tracking stroke of any type, systemic embolism, heart attack, or vascular death, the reported rates were 4.21% per year (apixaban) versus 6.35% per year (aspirin). The reported data also shows rates for all-cause death (3.51% vs 4.42% per year), vascular death (2.65% vs 3.03% per year), and a combined "net clinical benefit" measure that also factored in major bleeding (5.23% vs 7.13% per year). For bleeding, the reported major bleeding rates were 1.41% per year for apixaban and 0.92% per year for aspirin, while all bleeding combined was reported at 10.85% per year for apixaban and 8.32% per year for aspirin. In terms of adverse events, 1,833 participants in the apixaban group and 1,925 in the aspirin group experienced a serious adverse event, while 91 deaths were recorded in the apixaban group and 115 in the aspirin group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00716079 · results posted 28 October 2013

    According to the results reported on ClinicalTrials.gov, this trial involved 2,839 people in total — 1,403 in a group receiving more intensive blood pressure lowering treatment, and 1,436 in a group receiving blood pressure lowering treatment in line with standard medical guidelines. The trial was measuring outcomes after a stroke or bleeding in the brain, specifically looking at how many people either died or were left with significant disability (defined by a standard disability rating scale called the modified Rankin Scale, where a score of 3 to 5 indicates moderate to severe disability or worse). The vast majority of participants completed the study — 1,394 in the intensive treatment group and 1,421 in the guideline treatment group. The reported data shows that, for the main outcome (death or significant disability combined), 719 out of 1,403 participants in the intensive blood pressure lowering group and 785 out of 1,436 participants in the guideline treatment group met this combined outcome. For the secondary outcome of death within 90 days, the reported data shows 166 deaths in the intensive treatment group and 170 deaths in the guideline treatment group. These are the raw numbers of participants as submitted to ClinicalTrials.gov; no further breakdown or statistical analysis figures were included in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01047709 · results posted 10 June 2013

    According to the results reported on ClinicalTrials.gov, this trial involved 18 adults who took part in a crossover study — meaning each person spent one night using positional therapy (a method designed to influence how someone sleeps, such as encouraging them to avoid lying on their back) and one night as a control (sleeping in whatever position they chose). The trial was measuring the apnoea-hypopnoea index, or AHI — a count of the number of times per hour a person's breathing paused or became shallow during sleep. Half the participants tried positional therapy first, and the other half did the control night first. The reported data shows that on the positional therapy night, the average AHI was 27 events per hour, compared to 39 events per hour on the control night. To put those numbers in context, the trial's own description notes that an AHI of 15–30 is generally categorised as moderate and an AHI of 30 or above as severe. Both figures therefore fall within the moderate-to-severe range as defined in the study. All 18 participants completed both study nights, and no drop-outs were recorded. It is worth noting that the reported results only cover this one primary outcome measure; no secondary outcome data appears to have been submitted to ClinicalTrials.gov for this trial, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00412984 · results posted 29 April 2013

    According to the results reported on ClinicalTrials.gov, this trial (known as ARISTOTLE) enrolled 18,201 people with a heart rhythm problem called atrial fibrillation who were at risk of stroke. Participants were randomly assigned to take either apixaban (9,120 people) or warfarin (9,081 people). The trial was measuring how often people experienced a stroke or a blockage of blood flow to a part of the body (called systemic embolism), as well as serious bleeding episodes and deaths from any cause. The reported data shows that for the primary outcome — stroke or systemic embolism — 212 participants in the apixaban group and 265 in the warfarin group had at least one such event during the study period. Broken down further, the reported figures include 159 apixaban participants and 173 warfarin participants with an ischaemic or unspecified stroke, 38 versus 76 with a haemorrhagic (bleeding into the brain) stroke, and 15 versus 16 with systemic embolism. Expressed as a rate per 100 person-years (a way of accounting for different lengths of follow-up), this was 1.27 for apixaban and 1.60 for warfarin. For serious bleeding, 327 people in the apixaban group and 462 in the warfarin group experienced a major bleed, corresponding to rates of 2.13 and 3.09 per 100 person-years respectively. For deaths from any cause, 603 people in the apixaban group and 669 in the warfarin group died during the intended treatment period, at rates of 3.52 and 3.94 per 100 person-years. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00149227 · results posted 12 December 2012

    According to the results reported on ClinicalTrials.gov, this trial (NCT00149227) enrolled 3,031 people in total — 1,517 in a group that received the blood pressure medicine valsartan added to their usual treatment, and 1,514 in a comparison group that received other blood pressure medicines (not from the same drug family as valsartan). All participants completed the study. The trial was measuring the number of serious cardiovascular events — such as stroke, a brief stroke-like episode (called a transient ischaemic attack, or TIA), heart attack, heart failure requiring hospitalisation, and chest pain (angina) requiring hospitalisation — that occurred in each group. The reported data shows the following event counts across the two groups. For stroke, 25 events were recorded in the valsartan group compared with 46 in the non-valsartan group. For TIA (a short-lived stroke-like episode), 6 events were recorded in the valsartan group and 4 in the comparison group. For heart attack, 7 events were recorded in the valsartan group versus 11 in the comparison group. For heart failure requiring hospitalisation, 12 events were recorded in the valsartan group compared with 26 in the comparison group. For angina requiring hospitalisation, 22 events were recorded in the valsartan group versus 44 in the comparison group. The data for the outcome measuring surgical procedures (such as bypass surgery or a procedure to open blocked arteries) was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00376506 · results posted 26 October 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people in total — 4 in a group receiving vibrotactile stimulation (a gentle vibration-based treatment) and 6 in a group receiving intramuscular stimulation (delivered through a needle into the muscle). Both groups were receiving a form of treatment aimed at swallowing difficulties. By the end of the study, all 4 participants in the vibrotactile group had completed the trial, while 4 of the 6 in the intramuscular group completed it. The trial's main goal was to measure swallowing safety over time using specialised scales scored by speech pathologists watching recorded swallowing tests. The reported data shows that swallowing safety was measured using two main tools. The first, called the Swallowing Safety Scale (SSS), gives a score where 0 means completely safe swallowing and higher numbers indicate greater difficulties — there is no fixed maximum. For thin liquid swallows, the vibrotactile group scored around 8.4 at the start and 8.3 at follow-up, while the intramuscular group scored around 7.2 at the start and 7.4 at follow-up. For pudding swallows, both groups scored around 6.7–6.9 at the start and similar figures at follow-up. A second scale (the Penetration-Aspiration Scale, scored 0–8) also measured how deeply material entered the airway. The reported data shows scores ranging roughly from 1.4 to 5.8 across groups and food types at various time points. The reported data also includes several secondary measures. A scale rating how much food participants could eat orally (scored 1–7, where 1 means no oral nutrition) started at 1.0 for both groups and rose to around 3.25 and 3.0 at follow-up respectively. A quality-of-life questionnaire (scored 0–100, where lower means greater difficulty) started at roughly 55 and 51 for the two groups and rose to approximately 68 and 58 at follow-up. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00122980 · results posted 17 August 2012

    According to the results reported on ClinicalTrials.gov, this trial (NCT00122980) enrolled 133 children — 67 in a group receiving hydroxyurea (a medicine) plus phlebotomy (regular blood removal), and 66 in a group receiving regular blood transfusions plus chelation (treatment to remove excess iron from the body). All participants had previously had a stroke related to sickle cell disease, and the trial ran for 30 months. The two main things being measured were: whether participants had another stroke during the study, and whether the amount of iron stored in the liver changed over time. Not all participants completed the study — 43 in the hydroxyurea/phlebotomy group and 40 in the transfusion/chelation group did not finish. The reported data shows that, for the first main outcome (recurrent stroke), 7 out of 60 participants in the hydroxyurea/phlebotomy group experienced another stroke during the 30 months, compared with 0 out of 66 participants in the transfusion/chelation group. For the second main outcome (liver iron levels), both groups showed a small reduction from their starting levels when measured on a scientific scale (log scale), with the hydroxyurea/phlebotomy group changing by −0.006 units and the transfusion/chelation group changing by −0.120 units. For the secondary outcomes — which included quality-of-life questionnaires completed by parents and children, a measure of independence in daily activities (the Barthel Index), and tests of thinking and learning abilities — the reported data shows small changes from starting scores in both groups across all measures, with the numbers varying by category and group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00403767 · results posted 17 July 2012

    According to the results reported on ClinicalTrials.gov, this trial (NCT00403767) compared two blood-thinning medications — rivaroxaban and warfarin — in people with a heart rhythm condition called atrial fibrillation, where the main concern is preventing strokes and other blood clots travelling through the body. A total of 7,111 people were assigned to rivaroxaban and 7,125 to warfarin. Of those, around 4,591 and 4,657 people respectively completed the study, with roughly 2,500 in each group not completing it for various reasons. The reported data shows that the primary measure of stroke or blood clot events (measured while participants were actively taking their medication) recorded 188 patients in the rivaroxaban group and 241 in the warfarin group experiencing such an event in the non-inferiority analysis, and 189 versus 243 in the superiority analysis. For stroke alone, the reported figures were 184 patients in the rivaroxaban group and 221 in the warfarin group. When looking at a broader combined outcome that also included vascular death, the numbers reported were 346 (rivaroxaban) versus 410 (warfarin); and when heart attacks were also added in, the figures were 433 versus 519. The primary safety measure — tracking patients who experienced a major or clinically significant bleeding event — recorded 1,475 patients in the rivaroxaban group and 1,449 in the warfarin group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01153815 · results posted 17 May 2012

    According to the results reported on ClinicalTrials.gov, this trial enrolled 170 people in total — 83 received a placebo (an inactive dummy injection) and 87 received a 200-unit dose of botulinum toxin (BTX 200 U). The trial was looking at muscle stiffness in the wrist, fingers, and thumb — a condition called spasticity — which can occur after a stroke or similar brain injury. Stiffness was measured using a standard 6-point scale called the Modified Ashworth Scale (MAS), where 0 means no stiffness and 4 means the limb is completely rigid. The main thing the trial set out to measure was how much that wrist stiffness score changed after six weeks. The reported data shows that at week 6, the wrist stiffness score in the placebo group had dropped by an average of 0.56 points from where it started, while the BTX 200 U group showed a drop of 1.21 points. For finger stiffness at week 6, the reported drops were 0.42 points (placebo) and 1.05 points (BTX). For thumb stiffness at week 6, the drops were 0.53 points (placebo) and 1.06 points (BTX). The reported data also shows that at week 6, 36 people in the placebo group and 62 people in the BTX group had their wrist stiffness score fall by at least one full point — a threshold the trial defined as a meaningful response. These patterns were broadly similar at the other time points measured (weeks 1, 4, 8, and 12). The reported data also includes a summary score (called "area under the curve") that captures the overall change across both the week 6 and week 12 time points combined. For the placebo group this summary figure was reported as −2.341 (at week 6) and −5.618 (at week 12), compared with −5.672 and −12.712 for the BTX group. These are mathematical summaries of the score changes over time, not single measurements. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00414726 · results posted 16 September 2010

    According to the results reported on ClinicalTrials.gov, this trial involved 85 people who had experienced a stroke. Participants were randomly assigned to breathe either high-flow normobaric oxygen (pure oxygen at normal air pressure) or regular room air. The trial was measuring changes in stroke severity using a standard scoring tool called the NIH Stroke Scale (NIHSS) — a score that runs from 0 (no stroke symptoms) to 42 (most severe). The trial looked at two things: whether oxygen affected stroke severity during treatment (at 4 hours) and after treatment (at 24 hours). The reported data shows that, when looking at the 4-hour mark (during therapy), the average NIHSS score changed by −0.37 points in the oxygen group and −0.43 points in the room air group — meaning both groups showed a very small improvement in their scores over that period. At 24 hours (after therapy), the oxygen group's average score changed by +0.17 points (a very slight worsening), while the room air group's average score changed by −0.73 points (a slight improvement). These are the raw numbers as submitted; the trial was not large enough to draw broad conclusions, and no further breakdown of these figures was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00311402 · results posted 11 March 2010

    According to the results reported on ClinicalTrials.gov, this trial enrolled 655 people in the Aggrenox capsule group and 639 people in the aspirin (ASA 81 mg) group — a total of 1,294 participants. The trial was comparing the two treatments in people who had previously had a stroke caused by a blocked blood vessel (cerebral infarction), to measure how many went on to have another one. The main thing being tracked was whether participants experienced a further stroke of this type, either fatal or non-fatal. Not everyone finished the study: 210 people in the Aggrenox group and 177 in the aspirin group did not complete it, though the reasons for this are not detailed in the reported data. The reported data shows that, for the main outcome — a further blocked-vessel stroke — 45 patients in the Aggrenox group and 32 patients in the aspirin group recorded such an event. For the additional outcomes that were tracked, the reported numbers were: brain haemorrhage (bleeding in the brain), 12 in the Aggrenox group versus 7 in the aspirin group; a type of bleed around the brain called subarachnoid haemorrhage, 0 versus 1; a brief stroke-like episode (transient ischaemic attack, or "mini-stroke"), 3 versus 3; a heart-related event such as heart attack or unstable chest pain, 9 versus 16; and other blood vessel events (such as blood clots in the lung or legs, or blockages in other arteries), 11 versus 6. These figures are counts of the number of patients who experienced each event in each group, as adjudicated by an independent committee reviewing the cases without knowing which treatment each person received. The reported data does not include statistical comparisons or percentage rates, so no conclusions about the relative likelihood of these events between the two groups can be drawn from the numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00313820 · results posted 9 October 2009

    According to the results reported on ClinicalTrials.gov, this trial enrolled 220 people in total — 111 assigned to pregabalin and 109 assigned to a placebo (a dummy treatment with no active ingredient). The trial was measuring pain levels in participants over a 12-week treatment period, using a daily self-rated scale where 0 meant no pain and 10 meant the worst possible pain. Participants also tracked how much pain was disturbing their sleep each night, using the same type of scale. A separate pain questionnaire used a 0–100 millimetre line to capture overall pain intensity. The reported data shows that at the end of the 12-week period, the average pain score for the pregabalin group was 4.8 out of 10, compared with 5.0 out of 10 for the placebo group. Looking at weekly pain scores across the treatment period, the pregabalin group's scores ranged from around 4.7 to 5.6, while the placebo group's scores ranged from around 4.9 to 6.0. For sleep disturbance, the reported scores across the weeks ranged from 3.0 to 3.6 in the pregabalin group and 3.2 to 4.2 in the placebo group. On the separate 0–100 mm pain line, the pregabalin group scored 48.5 mm and the placebo group scored 49.5 mm. When it came to the number of people whose pain score dropped by at least 30% from the start, 48 out of 108 pregabalin participants reached that mark, compared with 35 out of 108 placebo participants. For a 50% or greater drop in pain score, 26 pregabalin participants and 22 placebo participants reached that threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00153062 · results posted 2 September 2009

    According to the results reported on ClinicalTrials.gov, this trial enrolled 20,332 people in total across four groups, all of whom had previously had a stroke. Participants were assigned to one of two blood-thinning medicines (either a combination of aspirin and extended-release dipyridamole, or clopidogrel on its own) and also either a blood pressure medicine called telmisartan or a dummy pill (placebo). The trial was designed to measure whether any of these medicines made a difference to the rate of further strokes and other serious heart and blood vessel events. Roughly 4,600–4,700 people in each group completed the study. The reported data shows that, when comparing the two blood-thinning approaches, 916 people taking aspirin plus dipyridamole had a further stroke, compared with 898 people taking clopidogrel. For the combined measure of stroke, heart attack, or death from a vascular cause, the reported numbers were identical — 1,333 participants in each of those two groups experienced one of these events. When looking at the telmisartan comparison, 880 people taking telmisartan had a further stroke, compared with 934 people taking the placebo. The reported data also shows that 1,367 people in the telmisartan group experienced the broader combined event (stroke, heart attack, vascular death, or worsening heart failure), compared with 1,463 in the placebo group. Additionally, 125 people in the telmisartan group were reported as developing new diabetes, compared with 151 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00334061 · results posted 12 January 2009

    According to the results reported on ClinicalTrials.gov, this trial enrolled 125 participants, all of whom completed the study. Every participant was treated with a device called the Penumbra System, which is designed to remove blood clots from blocked blood vessels in the brain during a stroke. The trial was measuring how well the device reopened the blocked vessel, as well as tracking serious problems related to the device or procedure, changes in stroke severity, participants' ability to carry out daily activities, and deaths. The reported data shows that in 81.2% of participants, blood flow in the treated vessel was restored to a meaningful level after the procedure (rated as a score of 2 or 3 on a standard blood-flow scale, where 0 means no flow and 3 means normal flow). Serious problems thought to be related to the device or procedure were recorded in 2.4% of participants. For the secondary measures, 41.6% of participants either showed a notable improvement on a stroke severity scale by the time they left hospital, or were largely able to look after themselves 30 days after treatment. At 90 days after treatment, 25% of participants scored at a level indicating they could mostly manage daily activities independently. The reported data also shows that 32.8% of participants died from any cause during the study period, and 11.2% experienced a bleed inside the skull that caused symptoms, detected by a brain scan taken 24 hours after the procedure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.