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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.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Clinical Research Coordinator
sebastian.liu@ucsf.edu
5175152739
Backup
Research Manager
sarah.wang@ucsf.edu
Time Frame
Start Date: 2026-04-09
Estimated Completion Date: 2031-11-30
Participants
Target number of participants: 24
Treatments
Experimental: Nighttime adaptive DBS programming
The 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).
Experimental: Daytime adaptive DBS Programming
Investigators 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...
Active_comparator: Open-loop continuous deep brain stimulation
Participants with Parkinson's disease implanted with Percept and receiving open-loop deep brain stimulation.
Sponsors
Leads: University of California, San Francisco
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov