Automated Daytime Adaptive Deep Brain Stimulation Parameter Optimization in Patients Implanted With Percept Neurostimulator

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07682311
Status
Recruiting
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Conditions

  • PD - Parkinson's Disease

Eligibility Criteria

Sex
ALL
Age
25 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Medtronic Percept Deep Brain Stimulation (adaptive DBS) — DEVICE
    Using the Percept pulse generator, patients receive adaptive stimulation to the subthalmaic nucleus.
  • Medtronic Percept Deep Brain Stimulation (cDBS) — DEVICE
    Using the Percept pulse generator, patients receive clinically-optimized open loop stimulation to the subthalmaic nucleus.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
May 31, 2030
Completion
May 31, 2032

Study Design

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

Arms

  • Experimental: Data-driven adaptive DBS programming
    Patients receive adaptive deep brain stimulation delivered through the Medtronic Percept PC/RC device, programmed with control parameters (sensing channel, detection thresholds, ramp rates, stimulation amplitude limits) recommended by the data-driven optimization pipeline and reviewed by a clinical researcher before programming. Stimulation amplitude is automatically adjusted between predefined upper and lower limits in response to sensed beta-band neural activity. Applied in counterbalanced 1-7 day blocks during awake hours in Session 6. These blocks will be randomized and counterbalanced for 40-60 days in patients' homes. Patients will be in cDBS mode overnight and will perform a blinded switch to either cDBS or aDBS upon waking in the morning.
  • Active Comparator: Open-loop continuous deep brain stimulation
    Participants with Parkinson's disease implanted with Percept and receiving open-loop deep brain stimulation.

Primary Outcome Measure

Change in number of bothersome movement symptoms on data-driven adaptive deep brain stimulation compared to open-loop deep brain stimulation [ Time Frame: Through study completion, an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94107
Sarah Wang, PhD
[email protected]
415-353-7885

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By research site
University of California San Francisco· San Francisco, CA

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