NCT07398157 · University of California, San Francisco
Simplified, Scalable, 24-hour Adaptive DBS in Parkinson's Disease
(Subgaleal aDBS)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Medtronic Percept Deep Brain Stimulation (cDBS)
Using the Percept pulse generator, patients receive clinically-optimized open loop stimulation to the subthalmaic nucleus.
DEVICE
Medtronic Percept Deep Brain Stimulation (daytime aDBS)
Using the Percept pulse generator, patients receive daytime adaptive stimulation to the subthalmaic nucleus.
DEVICE
Medtronic Percept Deep Brain Stimulation (nighttime aDBS)
Using the Percept pulse generator, patients receive nighttime adaptive stimulation to the subthalmaic nucleus.
Primary outcome measures
Change in number of bothersome movement and/or sleep episodes on adaptive deep brain stimulation compared to open-loop deep brain stimulation
Time frame: Baseline, aDBS testing, and during Blinded Assessment
Troublesome movement and/or sleep episodes will be detected using validated home wearable devices along with participant self-reporting.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- Coagulopathy, uncontrolled hypertension, heart disease, or other medical condition considered to place the patient at elevated risk for surgical complications.
- Patient meets criteria for a psychogenic movement disorder.
- Pregnancy: all women of childbearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
- Significant untreated depression (BDI-II score \>20) History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS).
- Any personality or mood symptoms that study personnel believe will interfere with study requirements.
- 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.
- Patients who experience adverse effects that are undesirable and detrimental to the health of subjects from DBS or other similar neurostimulators
Where
- San Francisco, California
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations