Simplified, Scalable, 24-hour Adaptive DBS in Parkinson's Disease
Subgaleal aDBS
Subgaleal Cortical Electrodes in Patients With Parkinson's Disease Undergoing Deep-brain Stimulation Therapy for Sensing and Adaptive Deep-brain Stimulation Over a 24-hour Period.
2 other identifiers
interventional
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2026
CompletedFirst Posted
Study publicly available on registry
February 9, 2026
CompletedStudy Start
First participant enrolled
April 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2031
May 5, 2026
April 1, 2026
3.6 years
February 2, 2026
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in number of bothersome movement and/or sleep episodes on adaptive deep brain stimulation compared to open-loop deep brain stimulation
Troublesome movement and/or sleep episodes will be detected using validated home wearable devices along with participant self-reporting.
Baseline, aDBS testing, and during Blinded Assessment
Secondary Outcomes (2)
Change in MDS-UPDRS III scores
Baseline, aDBS testing, and Blinded Assessment
Change in Total Electrical Energy Delivered (TEED)
Baseline, aDBS testing, and Blinded Assessment
Study Arms (3)
Nighttime adaptive DBS programming
EXPERIMENTALThe patient will undergo at-home blinded testing of the single power band N2/3 sleep stage aDBS (e.g 75% \& 125% conditions, levels chosen for each subject by the clinician or by the study team using data analysis) versus cDBS. Initially the patient will complete \~2 months (60 nights) of randomized, blinded, single night trials of aDBS at lower amplitude (e.g. 75%; 20 nights), aDBS at higher amplitude (e.g. 125% 20 nights) versus cDBS 100% (20 nights) to detect efficacy at the single subject level in independent N-of-1 trials. Stimulation amplitudes will be personalized and selected for tolerability and by searching for amplitudes that impact sleep physiology during the setup phase. Formal final testing will be completed in randomized, counterbalanced condition blocks. Patients will be in cDBS mode during the daytime and will perform a blinded switch to either cDBS or aDBS in the evening before going to sleep (or using the scheduling app).
Daytime adaptive DBS Programming
EXPERIMENTALInvestigators will conduct a blinded, randomized comparison between the effects of aDBS and clinically optimized cDBS on motor signs and symptoms. Both stimulation conditions will be applied for 1 day, in blocks of 2 days that are randomized and counterbalanced for over 40 days in patients' homes. Patients will be in cDBS mode overnight and will perform a blinded switch to either cDBS or aDBS in the morning on waking (these will appear to the patient as programs C and D). Investigators will utilize patients' daily symptom diaries and wearable data. They will ask patients to complete the symptom diary (an electronic questionnaire) every night before bedtime. This focuses on the total number of hours spent with symptoms, severity, and a quality of life (QoL) score validated for daily assessment of health-related QoL (EQ-5D). Evaluated symptoms include the most bothersome and opposite symptom as well as a range of common motor symptoms including bradykinesia, dyskinesia, tremor, etc...
Open-loop continuous deep brain stimulation
ACTIVE COMPARATORParticipants with Parkinson's disease implanted with Percept and receiving open-loop deep brain stimulation.
Interventions
Using the Percept pulse generator, patients receive clinically-optimized open loop stimulation to the subthalmaic nucleus.
Using the Percept pulse generator, patients receive daytime adaptive stimulation to the subthalmaic nucleus.
Using the Percept pulse generator, patients receive nighttime adaptive stimulation to the subthalmaic nucleus.
Eligibility Criteria
You may qualify if:
- Age 25-75.
- Diagnosis of idiopathic PD.
- Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist (Dr. Bledsoe).
- 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.
- Normal preoperative brain MRI.
- Absence of significant cognitive impairment (score of 24 or greater on the Montreal Cognitive Assessment (MoCA).
- Signed informed consent.
- 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).
- Motor fluctuations despite optimized medical therapy with at least 2 hours per day of either "off" time, or "on" with dyskinesias.
- Ability to comply with study follow-up visits for brain recording, testing of closed-loop stimulation, and clinical assessment.
You may not qualify if:
- Coagulopathy, uncontrolled hypertension, heart disease, or other medical condition considered to place the patient at elevated risk for surgical complications.
- Patient meets criteria for a psychogenic movement disorder.
- Pregnancy: all women of childbearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
- Significant untreated depression (BDI-II score \>20) History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS).
- Any personality or mood symptoms that study personnel believe will interfere with study requirements.
- 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.
- Patients who experience adverse effects that are undesirable and detrimental to the health of subjects from DBS or other similar neurostimulators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California San Francisco
San Francisco, California, 94158, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon Little
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
Philip Starr
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Blinded assessment phase for participants to compare study study-derived adaptive deep brain stimulation to clinically programmed continuous deep brain stimulation
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Clinical Neurology
Study Record Dates
First Submitted
February 2, 2026
First Posted
February 9, 2026
Study Start
April 9, 2026
Primary Completion (Estimated)
November 30, 2029
Study Completion (Estimated)
November 30, 2031
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share