Stroke Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People between 22 and 75 years of age
• People who have had an ischemic stroke (a stroke caused by a blocked blood vessel) in the past
• People who are at least 6 months past their ischemic stroke, where the stroke affected the outer layer of the brain (the cortex)
• People with a level of arm weakness on one side of the body that the medical team considers serious enough to warrant a surgical procedure
• People whose upper arm and hand function falls within a specific range on a standard medical scoring test called the Upper Extremity Fugl-Meyer scale, with a score between 25 and 45
• People whose overall disability level scores between 3 and 4 on a standard scale called the modified Rankin Scale, which measures how much a stroke affects daily life
• People whose brain scans (MRI) show that at least 30% of the nerve pathway that controls movement is still intact
• People whose muscles in the affected arm show a measurable response when a non-invasive brain stimulation technique (called TMS, or transcranial magnetic stimulation) is applied to the movement area of the brain
• People who are available to attend multiple visits over 54 weeks — 38 weeks with a device implanted, followed by 16 weeks of check-ups after the device is removed
• People whose eligibility has been assessed within 90 days before the planned implant procedure (the lead investigator may allow an exception to this timeframe for MRI results)

Who may not be able to join:

• People who are unable to stop taking anti-platelet medications (blood-thinning tablets such as aspirin or clopidogrel) for 7 days before and 3 days after surgery
• People currently taking therapeutic anticoagulant medication (stronger blood-thinning treatment)
• People with a history of unprovoked deep vein thrombosis (a blood clot in a vein without a clear cause) or any pulmonary embolus (a blood clot in the lungs)
• People with a bleeding disorder that would meaningfully increase the risk of a bleeding complication during study procedures
• People with other medical history that the investigator considers to indicate an increased risk of blood clots
• People with any history of seizures
• People who are pregnant
• People who score above 10 on a standard depression screening tool for older adults (Geriatric Depression Score)
• People who score below 22 on a standard memory and thinking assessment called the Montreal Cognitive Assessment — unless the low score is clearly due to a language difficulty (aphasia) and the lead investigator approves their participation
• People who score above 1 on a standard scale used to assess thoughts of suicide (Columbia Suicide Scale)
• People whose language difficulties or thinking and memory problems are significant enough to prevent them from communicating pain or discomfort, or from understanding the movement tests and rehabilitation tasks involved in the study
• People with severe neglect — a condition where a person is largely unaware of one side of their body or surroundings — as measured by a specific score of 2 on a standard stroke assessment question
• People with heart conditions that the investigators consider to represent an increased safety risk
• People with a history of a stroke caused by bleeding in the brain (hemorrhagic stroke)
• People with a significant, active neurological, psychiatric, or other medical condition that would likely interfere with study procedures
• People with any active infection currently being treated with antimicrobial medication
• People who are unable to participate in the rehabilitation program that is part of the study
• People who already have another implanted medical device, such as a pacemaker or cochlear implant
• People who require ongoing occupational therapy, physiotherapy, or speech therapy outside of what the study itself provides — the study does not permit additional therapy from outside sources
• All eligibility criteria are checked within 90 days before the implant procedure (with a possible exception for MRI results, at the lead investigator's discretion)
• People with certain shoulder or arm joint conditions (such as shoulder joint displacement, frozen shoulder, or limb contractures) will need to undergo additional pain assessments and must be individually approved by the enrolling clinician before joining
• People taking any medication not already addressed by the study's safety rules may be excluded, based on the clinical team's judgment on a case-by-case basis

Important: Always verify eligibility with the trial site directly before applying.