Recruiting

DBS

Sponsor:

UCLA

Code:

NCT07398157

Conditions

PD - Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Medtronic Percept Deep Brain Stimulation (cDBS)

Medtronic Percept Deep Brain Stimulation (daytime aDBS)

Medtronic Percept Deep Brain Stimulation (nighttime aDBS)

Study Details

Brief 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.

Conditions

PD - Parkinson's Disease

Study ID

NCT07398157

Start date

Apr 9, 2026

Status verified date

Apr, 2026

Completion date

Nov 30, 2031

Anticipated

Primary completion date

Nov 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nighttime adaptive DBS programming

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).

experimental: Daytime adaptive DBS Programming

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...

active comparator: Open-loop continuous deep brain stimulation

Participants with Parkinson's disease implanted with Percept and receiving open-loop deep brain stimulation.

Interventions

Medtronic Percept Deep Brain Stimulation (cDBS)

Using the Percept pulse generator, patients receive clinically-optimized open loop stimulation to the subthalmaic nucleus.

Medtronic Percept Deep Brain Stimulation (daytime aDBS)

Using the Percept pulse generator, patients receive daytime adaptive stimulation to the subthalmaic nucleus.

Medtronic Percept Deep Brain Stimulation (nighttime aDBS)

Using the Percept pulse generator, patients receive nighttime adaptive stimulation to the subthalmaic nucleus.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Clinical Research Coordinator

5175152739sebastian.liu@ucsf.edu

Research Manager

sarah.wang@ucsf.edu

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Sarah Wang, PhD

415-353-7885Sarah.Wang@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • Subgaleal
  • adaptive
  • DBS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-05-05.