Adaptive Deep Brain Stimulation to Improve Motor and Gait Functions in Parkinson's Disease

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 3 years 7 months later Sep 1, 2026 → Apr 1, 2030
See other at-risk trials from Doris Wang, MD, PhD

Record History

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  1. Primary completion pushed from Sep 1, 2026 to Apr 1, 2030 Show 4 more changesShow less
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 8 of 8 entries
    • Collaborators: details revised at 1 of 2 entries
    • Publications: details revised at 3 of 3 entries
  2. Primary completion date: Apr 1, 2026 to Sep 1, 2026v8
  3. Primary completion date: Apr 1, 2025 to Apr 1, 2026
    • Study completion date: Apr 1, 2025 to Apr 1, 2030
    v7
  4. Primary and study completion dates: Apr 1, 2024 to Apr 1, 2025v6
  5. Primary completion date: Jun 1, 2023 to Apr 1, 2024
    • Study completion date: Sep 1, 2023 to Apr 1, 2024
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Dec 1, 2022 to Jun 1, 2023
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Lead sponsor: University of California, San Francisco to Doris Wang, MD, PhD
    • Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Dec 1, 2021 to Jun 15, 2021
    • Site contact updated
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a single-center phase I 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) decode the physiological signatures of gait and gait adaptation by recording neural activities from the motor cortical areas and the globus pallidus during natural walking and a gait adaptation task, and 2) develop an adaptive deep brain stimulation (DBS) paradigm to selectively stimulate the pallidum during different phases of the gait cycle and measure improvements in gait parameters. This is the first exploration of network dynamics of gait in PD using chronically implanted cortical and subcortical electrodes. In addition to providing insights into a fundamental process, the proposed therapy will deliver personalized neurostimulation based on individual physiological biomarkers to enhance locomotor skills in patients with PD. Ten patients with idiopathic Parkinson's disease undergoing evaluation for DBS implantation will be enrolled in this single treatment arm study.
Trial Details
NCT Number NCT04675398
Lead Sponsor Doris Wang, MD, PhD
Collaborators: Michael J. Fox Foundation for Parkinson's Research, Burroughs Wellcome
Conditions
(from sponsor)		 Parkinson Disease
Related terms Parkinson Disease
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov