Parkinson's Disease Trial, By Invitation NCT04605263 Sponsor: St. Joseph's Hospital and Medical Center, Phoenix Condition: Parkinson's Disease
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Parkinson's Disease Trial, By Invitation

NCT04605263
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

  • A person must have signed a consent form agreeing to take part in the study.
  • A person must have been diagnosed with Parkinson's disease for at least 4 years, based on a specific set of recognised diagnostic standards.
  • A person's symptoms must improve by at least 30% when taking levodopa (a common Parkinson's medication).
  • A person must experience tremor or movement complications such as symptoms wearing off between doses or involuntary movements (dyskinesia).
  • A person must meet the criteria to be considered a candidate for deep brain stimulation (DBS) surgery, as defined by FDA guidelines.
  • A person must be considered suitable for a specific type of DBS targeting (called STN targeting) by a specialist review committee.
  • A person must have problems with balance and walking, or have had at least one fall in the past year, or have shown instability on balance tests.
  • A person must be at a specific stage of Parkinson's disease (Stage 2–3) with significant movement and posture difficulties, or have freezing of gait that does not respond to levodopa doses above 600 mg, along with a motor score above 6 on a standard Parkinson's assessment scale.
  • A person must be able to walk independently for short periods without a walking aid.
  • A person must be between 18 and 75 years of age.
  • A person must speak English as their primary language.
  • A person must be physically and mentally able to complete assessments and provide informed consent.
  • A person must have been medically cleared to undergo surgery and general anaesthesia.
  • Female participants who are able to become pregnant must have a negative blood pregnancy test before DBS surgery.

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 who have been diagnosed with dementia according to standard psychiatric diagnostic criteria (DSM-V).
  • People who have a condition that prevents them from having an MRI scan.
  • People who have a history of brain or spinal nervous system disease other than Parkinson's disease.
  • People who have a history of schizophrenia or delusions, or who are currently experiencing visual hallucinations that are not controlled.
  • People who need certain medical treatments that may interfere with the device, such as repetitive transcranial magnetic stimulation (rTMS), electroconvulsive therapy (ECT), diathermy, or repeated MRI scans.
  • People who have a history of seizures.
  • People who have made a suicide attempt within the past year.
  • People who have a medical condition that makes DBS surgery unsafe, such as an active infection, a blood clotting problem, or significant heart or other health risks.
  • People who already have an implanted electronic device, such as a pacemaker, defibrillator, another neurostimulator, or a cochlear implant.
  • People who are pregnant or currently breastfeeding.
  • People who are unwilling or unable to follow the requirements of the study, or who have a physical, mental, or social condition that is likely to make it difficult to do so.
  • People whom the trial investigator considers unsuitable for any other reason.

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 8 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
St. Joseph's Hospital and Medical Center, Phoenix
Registry
ClinicalTrials.gov
Start date
1 November 2021
Est. completion
1 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

STN-PPN Stimulation Effect on Fall Risk

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: 8 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