Deep Brain Stimulation for Parkinson's Disease
(Subgaleal aDBS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Simon Little
Principal Investigator
University of California, San Francisco
Philip Starr
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for people aged 25-75 with Parkinson's Disease who haven't found relief through oral medications. They should have a normal brain MRI, no serious cognitive issues (MoCA score ≥24), and experience motor fluctuations despite medication. Candidates must consent to the study and be able to attend follow-up visits.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Implantation and Initial Setup
Participants are implanted with deep brain stimulator devices and electrodes placed under the scalp. Initial setup and optimization of continuous DBS settings.
Daytime Adaptive DBS Programming
Blinded, randomized comparison between adaptive DBS and clinically optimized continuous DBS on motor signs and symptoms over 40 days.
Nighttime Adaptive DBS Programming
At-home blinded testing of adaptive DBS during sleep, with randomized, blinded, single night trials over approximately 2 months.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Medtronic Percept Deep Brain Stimulation
Trial Overview
Researchers are testing a new adaptive deep brain stimulation (DBS) method using Medtronic Percept devices implanted under the scalp. The goal is to tailor DBS settings based on brain signals related to movement and sleep symptoms, comparing these settings with standard continuous DBS treatment.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
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).
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...
Participants with Parkinson's disease implanted with Percept and receiving open-loop deep brain stimulation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
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