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Brain pacemaker gets a software upgrade to fight freezing gait

NCT ID NCT05292794

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a software called CereGate that fine-tunes an already-implanted deep brain stimulator to reduce freezing of gait in Parkinson's disease. About 41 participants will have their stimulator adjusted using the software. The goal is to see if this extra tuning can make walking smoother and safer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CereGate Software (a software that adjusts deep brain stimulation settings)
What this could lead to
If it works, this could offer a new way to reduce freezing of gait episodes in people with Parkinson's who already have a deep brain stimulator.
What could go wrong
This is a small, early study with only 41 participants. It is testing a software modification, not a new drug, so the benefits may be modest or not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 41 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant has an implanted STN-DBS system with Boston Scientific Gevia™ or Genus™ R16 IPG connected to any brand lead or extension that have been approved by the FDA to be used with Gevia or Genus IPGs. 2. Participant is receiving treatment with carbidopa/levodopa, and/or with a dopamine agonist at the optimal doses as determined by a movement disorders neurologist. 3. DBS optimized with documented improvement in motor signs (UPDRSIII) from DBS Exclusion Criteria: 1. Participant is unable to understand the study requirements and the treatment procedures, or unwilling / unable to provide written informed consent before any study-specific tests or procedures are performed. 2. Participant is unwilling or unable to comply with visit schedule and study related procedures. 3. Participant's medication regimen has not been stable for at least 28 days prior to CG initiation. 4. Participant's DBS stimulation settings have not been stable for at least 28 days prior to CG initiation. 5. Participant is less than 21 years of age or older than 80 years of age. 6. Participant is a female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception as determined by the study investigator. 7. Participant has a terminal illness with life expectancy of \< 1 year. 8. Participant has history of recurrent or unprovoked seizures. 9. Participant currently diagnosed with drug or alcohol abuse, per DSM-5 criteria. 10. Participant is in a very advanced stage of Parkinson's disease defined as: (i) Stage 5 as classified by the Hoehn and Yahr scale on medication and DBS (non-ambulatory) or (ii) participant requires an assistive device to perform the TBC OFF-meds /ON-DBS at the time of enrollment. 11. Participant has a condition that makes walking difficult or could interfere with the study procedures or confound the evaluation of the study data, including musculoskeletal issues, peripheral neuropathies, hip/knee prostheses, or any visual or anatomical abnormality that affects their walking. 12. Participant has disabling dyskinesias. 13. Participant has a history of suicide attempt or current active suicidal ideation as determined by a positive response to Items 2-5 of suicide ideation sub-scale of the Columbia Suicide Severity Rating Scale (CSSRS). 14. Participant, at the time of enrollment, fails the subthalamic nucleus (STN) stimulation challenge test (subject must perceive distinct bilateral sensations). 15. Participant has less than 8% arrhythmicity as measured in the Turning and Barrier Course Figures of 8 (TBC-F8) pre-CG therapy (ON Medications/ON DBS /OFF CG).

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Conditions

The condition(s) this trial relates to.

Gait Disorders, Neurologic Mobility Limitation Motor Disorders Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kaiser Permanente, KPNC Comprehensive Movement Disorders Program

    RECRUITING

    Redwood City, California, 94063, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Wake Forest University

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.