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Phase 1 Parkinson's Disease Trial, Not Yet Recruiting
NCT07267065
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility 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
Who may be able to join
- Adults aged 18 to 75 years (inclusive) at the time of signing the consent form.
- People who have been diagnosed with idiopathic Parkinson's disease, meaning Parkinson's that has no known external cause, with slowness of movement plus at least one of: muscle stiffness, a tremor at rest, or problems with balance and posture.
- People whose Parkinson's diagnosis was made more than 3 years ago.
- People who reported that their Parkinson's symptoms began before the age of 50.
- People whose Parkinson's disease has reached a certain level of severity (Modified Hoehn & Yahr stage 2.5 or higher) when measured after at least 12 hours without Parkinson's medications.
- People who experience an average of 3 or more hours per day of "OFF" time (periods when Parkinson's symptoms are not well controlled) during waking hours, as recorded in a Parkinson's diary in the 7 days before the screening visit.
- People whose Parkinson's motor symptoms score at least 25 points on a standard medical rating scale when measured in the "OFF" state (without medication).
- People who have shown a clear improvement of 30% or more in their motor symptoms when taking Parkinson's medications, compared to when they are off medications, for at least 1 year.
- People who, in the investigator's judgment, have been on a stable and optimised Parkinson's medication regimen for at least 4 weeks before the screening visit.
- People whose Parkinson's symptoms have been stable for at least 4 weeks before the screening visit, in the investigator's judgment.
- People whose pre-surgery blood test results fall within the following ranges (confirm with trial site for exact values): sufficient platelet levels without needing a transfusion; normal blood clotting levels; sufficient neutrophil (a type of white blood cell) count; sufficient haemoglobin level; liver enzyme levels within an acceptable range; bilirubin (a liver-related substance) below a certain level; creatinine (a kidney-related substance) at or below a certain level; haematocrit (the proportion of red blood cells) above a certain level; white blood cell count below a certain level; and kidney filtration rate at or above a certain level.
- People who are medically and mentally able to understand and sign the consent form, and to undergo and follow all requirements of the surgical procedure and study protocol, as determined by the investigator.
- People who are able to travel to study visits on their own, or who have a care partner willing to accompany them to visits.
- People who agree to postpone any brain surgery, including deep brain stimulation, until after the 12-month study visit has been completed.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People whose parkinsonism is caused by something other than an idiopathic (unknown) cause — for example, by a brain injury, tumour, infection, stroke, another neurological condition, or exposure to drugs, chemicals, or toxins.
- People with significant cognitive (thinking and memory) difficulties, as shown by a score below 24 on a standard cognitive test (MoCA), or a clinical diagnosis of dementia.
- People with a current or past history of psychosis, except for minor psychosis (confirm with trial site).
- People with severe depression, as indicated by a score above 28 on a standard depression scale (BDI-II) within 5 years of the screening visit.
- People with active thoughts of suicide as identified by a standard screening tool (C-SSRS), or anyone with a history of a suicide attempt.
- People with an impulse control disorder, as indicated by a score of 10 or more on a standard rating scale for impulsive and compulsive behaviours in Parkinson's disease (QUIP-RS).
- People with a history of substance use disorder within 2 years of the screening visit.
- People with abnormalities found on brain imaging that the investigator considers would significantly increase the risk of surgery.
- People who cannot undergo MRI scans or who have a contraindication to the contrast agent gadolinium (for example, the product ProHance).
- People with blood clotting problems, or who are unable to temporarily stop blood-thinning or antiplatelet medications for at least 2 weeks around the time of surgery.
- People who have previously had stereotactic brain surgery (such as deep brain stimulation, lesioning procedures, or infusion therapies) or any other prior brain surgery that could complicate the study procedure or affect study results.
- People who have previously received gene transfer therapy.
- People with a history of stroke, poorly controlled or significant heart disease, diabetes, or any other acute or ongoing medical condition that the investigator believes would unreasonably increase the risks of the study procedures.
- People with a history of cancer, other than treated carcinoma in situ, within 3 years of the screening visit.
- People with an active or laboratory-confirmed infection (including a scalp infection) at the time of screening, baseline assessments, or immediately before surgery.
- People who have received any experimental treatment within 30 days or within 5 half-lives of that treatment (whichever is shorter) before joining the trial.
- People who, in the investigator's judgment, have medical or personal circumstances that would likely prevent them from completing the study requirements, such as filling in Parkinson's diaries, attending frequent and lengthy study visits, or travelling.
- People currently receiving ongoing immune-suppressing treatments, including long-term steroids, immunotherapy, cytotoxic therapy, or chemotherapy.
- People with any serious medical condition or abnormal test finding that the investigator believes would significantly increase the risks of the study procedures.
- People with a medical condition likely to cause disability during the study that could interfere with study assessments — for example, bone or joint conditions, spinal disorders, nerve damage, severe lung or heart disease, or significant nutritional problems.
- People who are currently pregnant or breastfeeding.
- People of reproductive capacity (male or female) who are unwilling to use barrier contraception for 6 months after surgery.
- People currently taking certain medications that could affect the interpretation of study results, including antipsychotic medications, apomorphine, or levodopa infusion therapy (Duopa).
- People who plan to take part in any other therapeutic intervention study within 12 months after surgery.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
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Trial details
Status
Not Yet Recruiting
Phase
Phase 1
Sponsor
Krzysztof Bankiewicz
Registry
ClinicalTrials.gov
Start date
1 February 2026
Est. completion
1 August 2028
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Adverse Events; MRI findings; Physical Exam and labs; C-SSRS
Can't join this trial?
Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.