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

NCT07682311 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-02

No results posted yet for this study

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.

Conditions

  • PD - Parkinson's Disease

Interventions

DEVICE

Medtronic Percept Deep Brain Stimulation (adaptive DBS)

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

DEVICE

Medtronic Percept Deep Brain Stimulation (cDBS)

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

Sponsors & Collaborators

Principal Investigators

  • Simon Little, MBBS,PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2030-05-31
Completion
2032-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07682311 on ClinicalTrials.gov