Actively Recruiting
Simplified, Scalable, 24-hour Adaptive DBS in Parkinson's Disease
Led by University of California, San Francisco · Updated on 2026-05-05
24
Participants Needed
1
Research Sites
294 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to test a new way to treat Parkinson's disease (PD). Subjects will be implanted with deep brain stimulator (DBS) devices and electrodes placed under the scalp. The main questions it aims to answer are: * Is there a less invasive method to collect useful brain signals? Find out if these brain signals can be related to movement and/or sleep symptoms. * How to use these brain signals to tailor adaptive deep brain stimulation settings for movement and/or sleep symptoms Researchers will compare study derived adaptive DBS settings to subject's clinically programmed continuous DBS settings to see which is better at treating patients PD symptoms.
CONDITIONS
Official Title
Simplified, Scalable, 24-hour Adaptive DBS in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 25 to 75 years
- Diagnosis of idiopathic Parkinson's disease
- Inadequate symptom relief from oral medications as determined by a movement disorders neurologist
- Requested deep brain stimulation surgery or previous enrollment in related IDE study
- Normal preoperative brain MRI
- No significant cognitive impairment (Montreal Cognitive Assessment score 24 or higher)
- Signed informed consent
- Motor UPDRS-III off medication score between 25 and 65 with over 35% improvement with levodopa
- Predominant rigid/bradykinetic symptoms with limb rigidity/bradykinesia to tremor score ratio greater than 1.2
- Motor fluctuations despite optimized medical therapy with at least 2 hours per day of off time or on time with dyskinesias
- Ability to comply with study follow-up visits for brain recording, testing, and clinical assessment
You will not qualify if you...
- Coagulopathy, uncontrolled hypertension, heart disease, or other medical conditions increasing surgical risk
- Psychogenic movement disorder diagnosis
- Pregnancy or positive pregnancy test for women of childbearing potential prior to surgery
- Significant untreated depression (BDI-II score over 20) or history of suicidal attempt or active suicidal ideation
- Personality or mood symptoms interfering with study requirements
- Need for electroconvulsive therapy, repetitive transcranial magnetic stimulation, diathermy, implanted neurostimulators incompatible with MRI, previous craniotomy on the implant side, or drug/alcohol abuse
- Experience of undesirable adverse effects from DBS or similar neurostimulators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
Research Team
C
Clinical Research Coordinator
CONTACT
R
Research Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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