Brain pacemaker gets smarter to stop freezing in Parkinson's
NCT ID NCT06819020
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adaptive deep brain stimulation (DBS) can reduce or prevent freezing of gait in 20 people with Parkinson's disease. Participants already have DBS implants, and the device will adjust stimulation in real time based on brain signals. Freezing episodes will be tracked using wearable sensors and patient reports.
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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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Aug 2029
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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21 to 75 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. Ability to give informed consent for the study 2. Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria 3. Patient has requested surgical intervention with deep brain stimulation for their disorder 4. No magnetic resonance (MR) abnormalities that suggest an alternative diagnosis or contraindicate surgery 5. Absence of significant cognitive impairment (score of 21 or greater on the Montreal Cognitive Assessment (MoCA)), 6. Signed informed consent 7. Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment. 8. Age 21-75 9. Diagnosis of idiopathic PD with duration of motor symptoms for 3 years or greater 10. Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist. 11. UPDRS-III score off medication between 20 and 80 and an improvement of at least 30% in the baseline UPDRS-III on medication score, compared to the baseline off-medication score, and motor fluctuations with at least 2 hours per day of on time without dyskinesia or with non-bothersome dyskinesia. OR Patients with tremor-dominant PD (a tremor score of at least 2 on a UPDRS-III sub-score for tremor), treatment resistant, with significant functional disability despite maximal medical management 12. Patients with gait impairments including freezing of gait off medication. 13. Ability of patient and/or caregivers to recharge the system evaluated by all clinicians and study personnel. Exclusion Criteria: 1. Coagulopathy, anticoagulant medications, uncontrolled hypertension, history of seizures, heart disease, or other medical conditions considered to place the patient at elevated risk for surgical complications 2. Evidence of a psychogenic movement disorder: Motor symptoms that remit with suggestion or "while unobserved", symptoms that are inconsistent over time or incongruent with clinical condition, plus other manifestation such as "false" signs, multiple somatizations, or obvious psychiatric disturbance. 3. Pregnancy: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure. 4. Significant untreated depression (BDI-II score \>20). History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS) 5. Any personality or mood symptoms that study personnel believe will interfere with study requirements. 6. Subjects who require Electroconvulsive therapy (ECT), Repetitive Transcranial Magnetic Stimulation (rTMS) or diathermy 7. Implanted stimulation systems such as cochlear implant, pacemaker, defibrillator, or neurostimulator 8. Previous cranial surgery 9. Drug or alcohol abuse 10. Meets criteria for Parkinson's disease with mild cognitive impairment (PD-MCI). These criteria are performance of more than two standard deviations below appropriate norms, for tests from two or more of these five cognitive domains: attention, executive function, language, memory, and visuospatial tests. 11. Known allergies to the implantable device components including titanium, polyurethane, silicone, and nylon.
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Conditions
The condition(s) this trial relates to.
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
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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
San Francisco, California, 94143, United States
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Other studies related to the condition(s) this trial covers.
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