Simplified, scalable 24-hour adaptive deep brain stimulation for Parkinson's disease
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.
This study will test whether a less invasive under‑scalp recording system can drive around‑the‑clock adaptive deep brain stimulation to help people with Parkinson's disease who have motor fluctuations or sleep problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07398157 on ClinicalTrials.gov |
What this trial studies
Participants will be implanted with a Medtronic Percept DBS system and subgaleal (under‑scalp) electrodes to record chronic cortical signals. The recorded signals will be used to run daytime and nighttime adaptive DBS algorithms that are compared directly to each participant's clinically programmed continuous DBS. Primary outcomes include motor symptom measures, sleep metrics, and the stability and circadian variation of the recorded signals. The design aims to simplify hardware and reduce programming complexity so adaptive DBS can be scaled beyond specialist centers.
Who should consider this trial
Good fit: Adults aged 25–75 with idiopathic Parkinson's disease, motor UPDRS‑III 25–65 with >35% levodopa response, predominant rigidity/bradykinesia, and persistent motor fluctuations or sleep dysfunction despite optimized therapy who are candidates for DBS.
Not a fit: Patients with atypical parkinsonism, significant cognitive impairment, minimal motor fluctuations or sleep complaints, or contraindications to DBS or MRI are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide more personalized stimulation that improves daytime motor control and sleep while using less invasive cortical recordings.
How similar studies have performed: Prior proof‑of‑principle and randomized blinded studies of adaptive DBS have shown improved daytime motor symptoms and quality of life compared with continuous DBS, though subgaleal chronic recording methods are more novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 symptoms (ratio of off-medication UPDRS-III limb rigidity/bradykinesia scores to limb tremor scores of \>1.2). 9. Motor fluctuations despite optimized medical therapy with at least 2 hours per day of either "off" time, or "on" with dyskinesias. 10. Ability to comply with study follow-up visits for brain recording, testing of closed-loop stimulation, and clinical assessment. Exclusion criteria 1. Coagulopathy, uncontrolled hypertension, heart disease, or other medical condition considered to place the patient at elevated risk for surgical complications. 2. Patient meets criteria for a psychogenic movement disorder. 3. Pregnancy: all women of childbearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure. 4. Significant untreated depression (BDI-II score \>20) History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS). 5. Any personality or mood symptoms that study personnel believe will interfere with study requirements. 6. 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. 7. Patients who experience adverse effects that are undesirable and detrimental to the health of subjects from DBS or other similar neurostimulators
Where this trial is running
San Francisco, California
- University of California San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Simon Little — University of California, San Francisco
- Study coordinator: Clinical Research Coordinator
- Email: sebastian.liu@ucsf.edu
- Phone: 5175152739
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.