Parkinson's Disease Trial, Recruiting NCT05292794 Sponsor: CereGate Inc. Condition: Parkinson's Disease
Back to Parkinsons Disease

Parkinson's Disease Trial, Recruiting

NCT05292794
Recruiting Not Applicable

Who may 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 might be able to join this trial:

  • You have a brain stimulation device (deep brain stimulator) already implanted, specifically a Boston Scientific Gevia™ or Genus™ R16 model, that has been approved by the FDA for use with your other device components.
  • You are currently being treated with carbidopa/levodopa and/or a dopamine-boosting medication, at the best doses as recommended by a movement disorders specialist.
  • Your brain stimulation device has already been shown to improve your movement and motor symptoms.

Who may not be able to join:

  • You are unable or unwilling to understand what the study involves, or you are unwilling to sign a consent form agreeing to take part.
  • You are unable or unwilling to attend scheduled visits and follow study procedures.
  • Your medications have changed or been adjusted within the last 28 days before starting the study.
  • Your brain stimulator settings have been changed within the last 28 days before starting the study.
  • You are younger than 21 or older than 80 years of age.
  • You are a woman who is breastfeeding, pregnant, or of childbearing age and not using adequate birth control (as decided by the study doctor).
  • You have a serious illness where you are not expected to live beyond one year.
  • You have a history of seizures that happened more than once or without a clear cause.
  • You currently have a diagnosis of drug or alcohol addiction or misuse.
  • Your Parkinson's disease is in a very advanced stage — meaning you are unable to walk on your own, or you need a walking aid to complete a specific walking test used in the study.
  • You have a condition that makes walking difficult or could affect the study results, such as joint problems, nerve damage in your limbs, hip or knee replacements, or any vision or physical issue affecting how you walk.
  • You have severe, disabling involuntary movements (uncontrolled movements caused by your Parkinson's medication).
  • You have previously attempted suicide, or you are currently having thoughts of suicide (as measured by a standard assessment tool used in the study).
  • At the time of joining, you do not pass a specific test that checks whether your brain stimulator is working correctly in both sides of your brain (confirm with trial site).
  • Your walking pattern during a specific movement test does not show enough irregularity in a way required for the study to measure changes (confirm with trial site).

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 27 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.

Contact this trial

Principal Investigator: Kathleen Kmiecik, CereGate Inc.

Phone: 330-241-9098

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
CereGate Inc.
Registry
ClinicalTrials.gov
Start date
18 April 2022
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Primary Efficacy Objective

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: 27 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