Can a brain pacemaker unfreeze Parkinson's gait?
NCT ID NCT07781696
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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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
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35 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University of California San Francisco (UCSF)
San Francisco, California, 94143, United States
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University of Miami
Miami, Florida, 33125, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19107, United States
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