Brain implant learns to fight Parkinson's symptoms around the clock
NCT ID NCT07398157
First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 3 times
Summary
This study tests whether a deep brain stimulator (DBS) that automatically adjusts its settings can better control movement and sleep problems in people with Parkinson's disease. 24 adults aged 25-75 will have electrodes placed under the scalp to record brain signals. The device will then use those signals to tailor stimulation during the day and night. Researchers will compare this adaptive approach to standard continuous DBS to see which works better.
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) device
- What this could lead to
- If successful, this could lead to a more personalized DBS therapy that automatically adjusts to reduce Parkinson's symptoms throughout the day and night.
- What could go wrong
- This is a small, early-stage study (24 people) testing a new approach. The adaptive stimulation may not work better than standard settings, and the scalp electrodes could be less effective than more invasive methods.
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
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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 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Nov 2031
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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18 years and older
- 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 25-75. 2. Diagnosis of idiopathic PD. 3. Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist (Dr. Bledsoe). 4. Patient has requested surgical intervention with deep brain stimulation for their disorder or previous enrollment in sponsored IDE (G220241) to use Percept PC wired to subgaleal sensing, if patients have ongoing daytime fluctuations or sleep dysfunction despite cDBS optimization. 5. Normal preoperative brain MRI. 6. Absence of significant cognitive impairment (score of 24 or greater on the Montreal Cognitive Assessment (MoCA). 7. Signed informed consent. 8. Motor UPDRS-III off medication score 25 to 65 and a \>35% improvement with levodopa, predominant rigid/bradykinetic symptoms (ratio of off-medication UPDRS-III limb rigidity/bradykinesia scores to limb tremor scores of \>1.2). 9. Motor fluctuations despite optimized medical therapy with at least 2 hours per day of either "off" time, or "on" with dyskinesias. 10. Ability to comply with study follow-up visits for brain recording, testing of closed-loop stimulation, and clinical assessment. Exclusion criteria 1. Coagulopathy, uncontrolled hypertension, heart disease, or other medical condition considered to place the patient at elevated risk for surgical complications. 2. Patient meets criteria for a psychogenic movement disorder. 3. Pregnancy: all women of childbearing 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. Patient who requires electroconvulsive therapy, repetitive transcranial magnetic stimulation, or diathermy, implanted neurostimulators and MR-incompatible metallic implants, previous craniotomy on the side of the intended subgaleal implant, and drug or alcohol abuse. 7. Patients who experience adverse effects that are undesirable and detrimental to the health of subjects from DBS or other similar neurostimulators
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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
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
RECRUITINGSan Francisco, California, 94158, United States
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