Effects of Vagal Nerve Stimulation on Leg Muscle Activity and Posture in Parkinson's Disease

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07226284
Status
Recruiting
Apply to this trial

Conditions

  • PARKINSON DISEASE (Disorder)
  • Parkinson's Disease (PD)

Eligibility Criteria

Sex
ALL
Age
21 Years - 76 Years
Healthy Volunteers
Accepted

Interventions

  • Vagal nerve stimulation — DEVICE
    The gammaCore non-invasive vagus nerve stimulator (nVNS) is a hand-held portable device that is used to apply electrical stimulation to the vagus nerve via two electrodes.
  • No intervention — OTHER
    No nVNS is applied in the baseline experiment. Sham nVNS is applied for experiment two

Study Details

This study is designed to better understand the mechanisms contributing to impaired activation of leg muscles in people with Parkinson's disease (PD) and to test if stimulation of a nerve at the neck can improve muscle activation, walking and balance.

Key Dates

Start date
Feb 10, 2026
Status verified
Feb 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

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

Arms

  • Other: Baseline (no VNS)
    Within-subject and cross-sectional design that consists of 30 participants with PD (15 with PIGD and 15 without PIGD) and 15 matched controls.
  • Experimental: Real nVNS
  • Sham Comparator: Sham nVNS
    Sham VNS will be applied using setting that do not active the vagus nerve.

Primary Outcome Measure

Change in delta-F [ Time Frame: Within-session VNS: 0-60 minutes. Between VNS sessions: 1 - 4 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Movement Disorders LaboratoryMinneapolisMinnesota55414
Kristin Garland
[email protected]
612-505-6574

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By research site
Movement Disorders Laboratory· Minneapolis, MN

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