Actively Recruiting
Subgaleal Cortical Electrodes in Parkinson's Disease Patients Undergoing Deep Brain Stimulation for 24-hour Adaptive Therapy
Led by University of California, San Francisco · Updated on 2026-05-05
24
Participants Needed
1
Research Sites
104 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
Researchers are evaluating a new approach to treat Parkinson's disease by using deep brain stimulator (DBS) devices with electrodes placed under the scalp. The study aims to find less invasive ways to collect brain signals related to movement and sleep symptoms and to use these signals to customize adaptive DBS settings. They will compare these adaptive DBS settings to the standard continuous DBS to see which better helps manage Parkinson's symptoms. Participants will receive the Medtronic Percept RC DBS system implanted with cortical leads placed under the scalp and directional basal ganglia leads. The study includes multiple phases: initial optimization of continuous DBS, followed by periods of adaptive DBS during daytime and nighttime. Nighttime testing involves randomized, blinded trials of different stimulation amplitudes over about two months, while daytime testing compares adaptive DBS and continuous DBS in randomized blocks over 40 days at home. Participants will be monitored through symptom diaries, wearable devices, and clinical assessments. Researchers will evaluate changes in bothersome movement and sleep episodes, motor function scores, and electrical energy delivered by the device. The study includes in-clinic and at-home brain recordings, sleep lab assessments, and quality of life measures. The total study duration includes long-term follow-up to support future clinical use of adaptive DBS in Parkinson's disease.
CONDITIONS
Brief Title
Simplified, Scalable, 24-hour Adaptive DBS in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 25 and 75 years
- Diagnosis of idiopathic Parkinson's disease
- Inadequate symptom relief from oral medications as determined by a movement disorders neurologist
- Patient has requested deep brain stimulation surgery or previously enrolled in a related study
- Normal preoperative brain MRI
- Montreal Cognitive Assessment score of 24 or greater
- Signed informed consent
- Motor UPDRS-III off medication score between 25 and 65 with over 35% improvement after levodopa
- Presence of 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, stimulation testing, and clinical assessment
You will not qualify if you...
- Coagulopathy, uncontrolled hypertension, heart disease, or other conditions increasing surgical risk
- Diagnosis of psychogenic movement disorder
- Pregnancy or positive pregnancy test prior to surgery
- Significant untreated depression or history of suicidal attempt or active suicidal ideation
- Personality or mood symptoms interfering with study participation
- Need for electroconvulsive therapy, repetitive transcranial magnetic stimulation, implanted neurostimulators incompatible with MRI, previous craniotomy on implant side, or drug/alcohol abuse
- Adverse effects from DBS or similar neurostimulators detrimental to health
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus immediate recovery period
Participants undergo implantation of the Medtronic Percept RC device with subgaleal frontal cortex leads and directional basal ganglia leads for deep brain stimulation.
1 surgical visit plus immediate post-operative monitoring
Duration - Up to approximately 4 months of alternating treatment blocks
Participants receive clinically optimized open-loop continuous deep brain stimulation (cDBS) and undergo alternating periods of daytime and nighttime adaptive deep brain stimulation (aDBS) in randomized, blinded crossover fashion.
Daily symptom diary entries plus multiple in-clinic and at-home visits for device programming and monitoring
Duration - Continues after treatment completion until study end
Participants are monitored through clinical assessments and data collection to evaluate motor symptoms and sleep improvements with aDBS compared to cDBS.
Multiple follow-up visits for clinical assessment and device evaluation
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
R
Research Manager
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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