Simplified, Scalable, 24-hour Adaptive DBS in Parkinson's Disease
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 brai
| Condition(s) | PD - Parkinson's Disease |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion criteria 1. Age 25-75. 2. Diagnosis of idiopathic PD. 3. Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist (Dr. Bledsoe). 4. 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. 5. Normal preoperative brain MRI. 6. Absence of significant cognitive impairment (score of 24 or greater on the Montreal Cognitive Assessment (MoCA). 7. Signed informed consent. 8. Motor UPDRS-III off medication score 25 to 65 and a \>35% improvement with levodopa, predominant rigid/bradykinetic |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of California, San Francisco |
| Locations | San Francisco, California, United States |
| Start date | 2026-04-09 |
| NCT ID | NCT07398157 |
| Official listing | https://clinicaltrials.gov/study/NCT07398157 |