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.
University of California, San Francisco
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.
Description
Parkinson's disease (PD) affects 1% of people over 60 years old, is highly disabling and represents a large economic burden. Therapeutic options include dopaminergic replacement and conventional DBS (cDBS) for advanced disease. However, cDBS therapy is currently unresponsive to the dynamic clinical states of patients, resulting in suboptimal control of symptoms during the day. Adaptive DBS (aDBS) seeks to solve this through personalized dynamic modulation of stimulation according to neural signals. Early studies of aDBS (completed by Drs Little, Starr and other research groups) provide proof-o…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceMedtronic Percept Deep Brain Stimulation (cDBS)
Using the Percept pulse generator, patients receive clinically-optimized open loop stimulation to the subthalmaic nucleus.
- DeviceMedtronic Percept Deep Brain Stimulation (daytime aDBS)
Using the Percept pulse generator, patients receive daytime adaptive stimulation to the subthalmaic nucleus.
- DeviceMedtronic Percept Deep Brain Stimulation (nighttime aDBS)
Using the Percept pulse generator, patients receive nighttime adaptive stimulation to the subthalmaic nucleus.
Location
- University of California San FranciscoSan Francisco, California