Parkinson's Disease Trial, By Invitation NCT06819020 Sponsor: Doris Wang, MD, PhD Condition: Parkinson's Disease
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Parkinson's Disease Trial, By Invitation

NCT06819020
By Invitation Not Applicable

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

  • The person must be able to give their informed consent to take part in the study.
  • Movement disorder symptoms must be severe enough, even with the best available medicines, that a specialist considers brain stimulation surgery to be appropriate.
  • The person must have requested surgery using deep brain stimulation for their condition.
  • Brain scans must show no abnormalities that would suggest a different diagnosis or make surgery unsafe.
  • The person must not have significant memory or thinking difficulties (a score of 21 or higher on a standard cognitive test called the MoCA).
  • The person must have signed an informed consent form.
  • The person must be able to attend follow-up visits for brain activity recording, stimulation testing, and clinical check-ups.
  • The person must be between 21 and 75 years of age.
  • The person must have a confirmed diagnosis of Parkinson's disease (the type with no known cause) with motor symptoms lasting 3 years or more.
  • The person must have already tried appropriate oral medications without enough relief, as determined by a specialist in movement disorders.
  • The person must have a motor symptom score (UPDRS-III) between 20 and 80 when off medication, and show at least a 30% improvement in that score when on medication, plus experience fluctuations in symptom control with at least 2 hours per day of good functioning (with no, or only minor, involuntary movements).
  • Alternatively, people with tremor-dominant Parkinson's disease (a tremor score of at least 2 on the relevant part of the UPDRS-III assessment) that has not responded well to treatment and causes significant difficulty in daily life despite maximum medication management may meet this criterion.
  • People who experience walking difficulties including freezing of gait when off medication may meet this criterion.
  • The person (and/or their caregiver) must be assessed by the clinical team as able to recharge the implanted device.

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 with blood clotting problems, use of blood-thinning medications, uncontrolled high blood pressure, a history of seizures, heart disease, or other medical conditions that a doctor considers to increase the risk of surgical complications.
  • People whose movement symptoms appear to have a psychological rather than neurological cause — for example, symptoms that disappear with suggestion or when the person thinks they are unobserved, are inconsistent over time, or are accompanied by other signs such as multiple unexplained physical complaints or obvious psychiatric disturbance.
  • People who are pregnant; all women who could become pregnant will be required to have a negative pregnancy test before surgery.
  • People with significant untreated depression (a score above 20 on the BDI-II scale), a history of a suicide attempt, or current thoughts of suicide (as identified by specific questions on a standard assessment tool called the C-SSRS).
  • People with personality or mood-related symptoms that the study team believes would interfere with taking part in the study.
  • People who need or may need electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or a type of heat-based medical treatment called diathermy.
  • People who already have an implanted device such as a cochlear implant, pacemaker, heart defibrillator, or another nerve stimulator.
  • People who have had previous brain surgery.
  • People with a current problem with drug or alcohol misuse.
  • People who meet the criteria for Parkinson's disease with mild cognitive impairment — meaning they score more than two standard deviations below normal on tests in two or more areas of thinking, including attention, planning, language, memory, and visual-spatial skills.
  • People with known allergies to any components of the implantable device, including titanium, polyurethane, silicone, or nylon.

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.
Last synced 15 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

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.

GP referral letter

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Trial details

Status
By Invitation
Phase
Not Applicable
Sponsor
Doris Wang, MD, PhD
Registry
ClinicalTrials.gov
Start date
31 January 2026
Est. completion
1 August 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Freezing of gait

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

View original record on ClinicalTrials.gov