Optimizing Adaptive DBS for Parkinson's Disease

Part of paid clinical trials in Davis, California.

Sponsor
University of California, Davis
Study ID
NCT07798271
Status
Recruiting
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Conditions

  • PARKINSON DISEASE (Disorder)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • aDBS-Extended (Medtronic Percept™) — DEVICE
    All parameters are derived from Steps 2-4. Amplitude modulation is based on individualized biomarker thresholds established through in-clinic and at-home testing, within the participant's effective stimulation amplitude range. Delivered via implanted Medtronic Percept™ DBS system using FDA-approved settings.
  • aDBS-Standard (Medtronic Percept™) — DEVICE
    aDBS-Standard, with stimulation parameters optimized by an independent clinician using the current standard clinical programming procedure, with iterative programming across multiple visits as needed.
  • Continuous DBS (cDBS) - Active Control (Medtronic Percept™) — DEVICE
    Participants receive their clinically optimized continuous DBS settings without adaptive modulation. Adaptive DBS parameters are configured to maintain blinding, but stimulation amplitude remains fixed at the standard cDBS level. Active stimulation is delivered throughout the study via the implanted Medtronic Percept™ DBS system.

Study Details

Parkinson's disease (PD) affects more than 10 million people worldwide and causes progressive motor symptoms such as slowness, stiffness and tremor. For patients whose symptoms are no longer adequately controlled with medication, deep brain stimulation (DBS) can substantially improve motor function. More recently, adaptive DBS (aDBS) has become available. Unlike conventional DBS, which delivers continuous stimulation, aDBS automatically adjusts stimulation in response to brain activity recorded by the implanted device. Current clinical aDBS programming is based primarily on brief recordings obtained during clinic visits. However, Parkinson's symptoms and the underlying brain signals change throughout the day in response to medication, daily activities and other factors. As a result, recordings collected during a single clinic visit may not fully capture the neural activity that best reflects a patient's symptoms in everyday life. The purpose of this study is to determine whether incorporating long-term brain recordings collected during daily life improves adaptive DBS programming and clinical outcomes. Participants will first undergo in-clinic testing to identify brain signals associated with their symptoms. Brain activity and symptoms will then be monitored during everyday life using the sensing capabilities of the implanted DBS device. Participants with suitable brain signals will enter a randomized, blinded crossover study comparing three stimulation approaches: conventional continuous DBS, adaptive DBS programmed using the current clinic-based approach and adaptive DBS programmed using both clinic and at-home recordings. The study will compare the effects of these approaches on motor fluctuations and quality of life. It will also determine how frequently different brain signals occur in people with Parkinson's disease and how well they reflect motor symptoms, providing information that may improve future adaptive DBS therapies.

Key Dates

First listed
Sep 1, 2026
Start date
May 8, 2026
Status verified
Aug 2026
Primary completion
Jul 1, 2032
Completion
Jul 1, 2032

Study Design

Enrollment
35 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: aDBS-Extended
    Adaptive DBS 1 - Extended (aDBS-Extended): neural signal biomarkers and thresholds established through an extended optimization protocol that integrates in-clinic and at-home recordings across multiple medication states. Participants receive this condition for 1 week per block, repeated 8 times over \~6 months in randomized crossover with the other two conditions.
  • Active Comparator: aDBS-Standard
    Adaptive DBS 2 - Standard (aDBS-Standard): neural signal biomarkers and thresholds optimized during short, limited programming sessions, consistent with Medtronic's recommended clinical procedure. Participants receive this condition for 1 week per block, repeated 8 times over \~6 months in randomized crossover with the other two conditions.
  • Active Comparator: Continuous DBS (cDBS) - Active Control
    Continuous DBS (cDBS, active control): constant amplitude at the participant's stable clinical setting. Biomarker and frequency band parameters will be recorded but will not modulate stimulation. Participants receive this condition for 1 week per block, repeated 8 times over \~6 months in randomized crossover with the other two conditions.

Primary Outcome Measure

Prevalence and Spectral Properties of STN Local Field Potential Peaks [ Time Frame: Neural recordings obtained during 1 in-clinic session. For participants in Part 2, selected neural biomarker will be recorded for 14 days, and symptom and medication logs completed on 3 of those days. Events are recorded for predefined symptoms. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis Center for NeuroscienceDavisCalifornia95618
Annie K Abay
[email protected]
408-728-0148

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By research site
UC Davis Center for Neuroscience· Davis, CA

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