Movement State-dependent Adaptive DBS for PD

Part of paid clinical trials in San Francisco, California.

Sponsor
Doris Wang, MD, PhD
Study ID
NCT07424508
Status
Enrolling By Invitation

Conditions

  • Parkinson's Disease (PD)

Eligibility Criteria

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

Interventions

  • Summit RC+S — DEVICE
    Participants receive gait-optimized stimulation settings while walking and Parkinson's disease symptom-optimized settings during non-walking periods.
  • Summit RC+S — DEVICE
    Participants receive clinically-optimized open-loop deep brain stimulation ot the pallidum.

Study Details

This is a single-center clinical study aiming to improve gait functions in patients with Parkinson's Disease (PD) by using adaptive neurostimulation to the pallidum. The investigators will use a bidirectional deep brain stimulation device with sensing and stimulation capabilities to 1) identify neural biomarkers to detect the onset of walking by recording neural activities from the motor cortical areas and the globus pallidus, 2) understand the impacts of changes in DBS parameters on gait kinematics and optimize setting parameters for enhancing walking performance, 3) develop a movement state-dependent adaptive deep brain stimulation (DBS) paradigm to automatically switch stimulation settings according to different movement states (i.e., walking vs non-walking). The proposed therapy will deliver personalized neurostimulation based on individual physiological biomarkers to enhance gait function in patients with PD. 6 patients with idiopathic Parkinson's disease who have already been implanted with the Medtronic Summit RC+S device will be enrolled in this study.

Key Dates

Start date
Feb 4, 2026
Status verified
Feb 2026
Primary completion
Sep 1, 2026
Completion
Apr 1, 2030

Study Design

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

Arms

  • Active Comparator: Continuous (open-loop) deep brain stimulation
    Parkinson's disease patients implanted with Summit RC+S and brain lead implanted in the pallidal/striatal region receiving open-loop deep brain stimulation.
  • Active Comparator: Movement state-dependent adaptive (closed-loop) deep brain stimulation
    Parkinson's disease patients implanted with Summit RC+S and brain lead implanted in the pallidal/striatal region receiving movement state-dependent adaptive (closed-loop) deep brain stimulation.

Primary Outcome Measure

Change in Mini Balance Evaluation Systems Test (Mini-BESTest) Scores [ Time Frame: after each 7 day block ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCSFSan FranciscoCalifornia94134-

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By research site
UCSF· San Francisco, CA

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