NCT07682311 Automated Daytime Adaptive Deep Brain Stimulation Parameter Optimization in Patients Implanted With Percept Neurostimulator
| NCT ID | NCT07682311 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | PD - Parkinson's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-06 |
| Primary Completion | 2030-05 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-06 with a primary completion date of 2030-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Parkinson's disease (PD) affects \~1% of people over 60 years old, is highly disabling and represents a large economic burden. While dopaminergic medications effectively treat motor symptoms early in the disease, most patients develop complications, including motor fluctuations and dyskinesias, which can be partially managed by deep brain stimulation (DBS). This surgical therapy consists of delivering continuous electrical stimulation through electrodes permanently implanted in basal ganglia nuclei, with a pulse generator and battery unit implanted in the chest. However, conventional DBS therapy is delivered with constant stimulation parameters, referred to as constant deep brain stimulation (cDBS), that are unresponsive to patient activities or to variations in the severity of symptoms during daily life. This leaves many patients under- or over-stimulated during parts of the day. To address the shortcomings of cDBS, adaptive DBS (aDBS) uses real-time detection of neural signals to automatically adjust stimulation amplitude or other parameters in response to patients' dynamic clinical needs. aDBS was approved by the U.S. Food and Drugs Administration (FDA) for clinical treatment of PD in the Percept PC and RC (Medtronic) device in February 2025. Fully leveraging this therapy in the real world is limited by technical challenges, in particular the fact that: while the investigators developed a consistent pipeline for implementing aDBS, there were several critical control parameters that strongly influenced algorithm performance and required prolonged trial-and-error based testing, to achieve successful control. In this new study, the investigators seek to significantly extend this work and address the major barriers to widespread, easy adoption of aDBS by groups without specialized knowledge of neurophysiology or feedback control. Here the investigators aim to test an automated, data-driven pipeline for the recommendation of the adaptive control parameters.
Eligibility Criteria
Inclusion Criteria: 1. Age 25-75. 2. Diagnosis of idiopathic PD. 3. Patient has undergone surgical intervention with deep brain stimulation (Percept device) for their disorder at least 2 months prior to recruitment. 4. Absence of significant cognitive impairment (score of 24 or greater on the Montreal Cognitive Assessment (MoCA)). 5. Signed informed consent. 6. Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment. 7. Patient has been on cDBS for at least two months and still experiences significant residual motor fluctuation while on cDBS. Consequently, patient is undergoing aDBS treatment currently or was recommended aDBS as part of clinical care to manage their residual motor fluctuation. 8. Has available cDBS Timeline LFP and stimulation data lasting at least 1 day. 9. To be enrolled in the clinical trial phase of the study, patient will need to consent to reverting back to their baseline cDBS settings for all required cDBS testings. Exclusion Criteria: 1. Patient meets criteria for a psychogenic movement disorder. 2. Significant untreated depression (BDI-II score \>20). History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS). 3. Any personality or mood symptoms that study personnel believe will interfere with study requirements.
Contact & Investigator
Simon Little, MBBS,PhD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07682311 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 75 Years, studying PD - Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07682311 currently recruiting?
Yes, NCT07682311 is actively recruiting participants. Contact the research team at sebastian.liu@ucsf.edu for enrollment information.
Where is the NCT07682311 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07682311 clinical trial?
NCT07682311 is sponsored by University of California, San Francisco. The principal investigator is Simon Little, MBBS,PhD at University of California, San Francisco. The trial plans to enroll 40 participants.
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