Can a brain pacemaker unfreeze Parkinson's gait?

NCT ID NCT07781696

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This trial investigates whether deep brain stimulation (DBS) of a specific brain region, the cuneiform nucleus, can safely and effectively reduce freezing of gait in people with Parkinson's disease when standard treatments no longer help. The study involves 18 participants aged 35 to 80 with Parkinson's who experience disabling freezing episodes. Researchers will compare active stimulation to sham (sub-therapeutic) stimulation to see if it improves walking and turning, using the Medtronic Percept system, which is FDA-approved for other conditions but experimental for this use.

What this could mean

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

Active substance
Deep brain stimulation (DBS) of the cuneiform nucleus (CnF) using Medtronic Percept PC or RC systems
What this could lead to
If effective, this could offer a new treatment option for Parkinson's patients with disabling freezing of gait that doesn't respond to standard medications, potentially improving mobility and quality of life.
What could go wrong
This is an early, small trial (18 participants) testing an experimental use of an approved device. The stimulation target is new, and the therapy may not work for everyone or could carry risks from brain surgery and stimulation.

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 18 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

35 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. Age between 35 and 80 years 2. Confirmed diagnosis of PD, according to a movement disorder neurologist, with documented exclusion of other disorders such as Frontotemporal Dementia (FTD), frontal gait disorder, Normal Pressure Hydrocephalus (NPH), or Progressive Supranuclear Palsy (PSP) 3. Postural Instability and Gait Difficulty (PIGD)-predominant PD, defined by a Tremor-Dominant (TD)/PIGD ratio of ≤ 0.90, as calculated from MDS-UPDRS items, according to previously validated methods46 4. FOGQ score of \> 12, consistent with severe gait disorder47-49 5. Clinical observation of FOG in ON and/or OFF medication states by a movement disorder neurologist 6. FOG refractory to optimized dopaminergic therapy by a movement disorder neurologist 7. Minimal tremor, bradykinesia, and rigidity, or well controlled motor symptoms with optimized dopaminergic therapy and/or previously implanted STN or GPi DBS, such that FOG and axial dysfunction represent the predominant disabling motor features 8. Adequate cognitive function (e.g., Mattis Dementia Rating Scale-2 (DRS-2) \> 130) and absence of major uncontrolled psychiatric illness (e.g., Beck's Depression Inventory-II (BDI-II) ≤ 25) 9. Willingness and ability to comply with protocol requirements (e.g., procedure visits, treatment schedule, follow-up visit schedule, evaluations, etc.), at the principal investigator's discretion 10. Willingness and ability to provide written agreement to allow any and all forms of communication between the research team and treating clinician(s) 11. Willingness and ability to provide informed consent, at the principal investigator's discretion Exclusion Criteria: 1. Major executive dysfunction or dementia (DRS-2 ≤ 130) or other neurocognitive impairments that would interfere with informed consent or study participation, at the principal investigator's discretion 2. Depression, defined, for example, by BDI-II \> 25 or diagnosis of one or more other high-risk psychiatric conditions (e.g., substance use disorder, severe anxiety, uncontrolled bipolar disorder), at the principal investigator's discretion 3. Presence of high suicide risk on the Columbia-Suicide Severity Rating Scale (C-SSRS) as defined below Participants will be excluded if they endorse active suicidal ideation with intent to act (C-SSRS Severity Level 4 or 5) during screening, report a suicide attempt, interrupted attempt, or aborted attempt within the previous 6 months, or are determined by the study psychiatrist and/or principal investigator to present clinically significant suicide risk. 4. Major medical co-morbidities and other surgical contraindications such as uncontrolled hypertension, severe cardiopulmonary disease, coagulopathy, epilepsy, prior intracranial hemorrhage, or significant cerebrovascular disease, at the principal investigator's discretion 5. Need for diathermy, TMS, or ECT during the study 6. History of prior intracranial surgery (other than prior STN or GPi DBS for PD) that substantially alters anatomy or risk at the CnF target, at the principal investigator's discretion 7. Any metallic implant in the head that is not MRI-compatible (e.g., certain aneurysm clips, cochlear implants) 8. Active implantable devices anywhere in the body (e.g. pacemaker, defibrillator, spinal cord stimulator, implanted medication pump) that may affect imaging quality or interact with DBS, unless specifically permitted by device labeling and investigator judgment 9. Pregnancy, intent to become pregnant during the study, breastfeeding, or unwillingness to use an acceptable method of contraception throughout the course of the trial 10. Current participation in other interventional trials or use of investigational drugs or devices that may influence gait or DBS outcomes, at the principal investigator's discretion

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As listed by the trial registrant

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How to take part

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

  1. The places running it

    3 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

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Contacts and locations

Locations

  • University of California San Francisco (UCSF)

    San Francisco, California, 94143, United States

  • University of Miami

    Miami, Florida, 33125, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19107, United States

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