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Multiple Sclerosis (MS) - Relapsing-remittingDigital healthDevice

What this study is

The goal of this clinical trial is to learn if stimulating the vagus nerve in combination with a motor task in people with multiple sclerosis can improve motor function. The main questions it aims to answer are:

  • Is stimulating the vagus nerve safe and feasible after demyelinating episodes?
  • Does a paired motor task with vagus nerve stimulation improve motor function with someone who has multiple sclerosis?

Researchers will compare active vagus nerve stimulation to a sham stimulation to see if the paired vagus nerve stimulation can improve motor control.

Participants will:

  • Come in for study visits over a six month period. Study visits are three times weekly for the first month, then single follow up visits at two, three, and six months.
  • During study visits, participants will complete 30 minutes of the paired vagus nerve stimulation with a motor task, specifically the grooved peg test.
  • At various timepoints throughout the study, motor, disability, and neurophysiological assessments will be administered, including the Timed 25-Foot Walk Test, Expanded Disability Status Scale (EDSS), Upper Extremity portion of the Fugl-Meyer Assessment, Dellon-Modified Moberg Pick-Up Test, Multiple Sclerosis Impact Scale-29 (MSIS-29), motor evoked potentials (MEPs), and visual evoked potentials (VEPs). MRI assessments will also be performed to evaluate exploratory imaging metrics of potential remyelinative efficacy.

What's being tested

  • Closed Loop Trans-Auricular Vagus Nerve Stimulation System

    Intervention · DEVICE

    A closed loop system that delivers stimulation to the vagus nerve via the ear non-invasively following a trigger event.

  • Placebo

    Intervention · DEVICE

    A closed-loop vagus nerve stimulation device that can deliver sham stimulation to the ear to simulate stimulation of the vagus nerve.

Study details

Official title
Vagus Nerve Stimulation to Promote Remyelination in Multiple Sclerosis
Sponsor
University of Colorado, Denver
Conditions
Multiple Sclerosis (MS) - Relapsing-remitting · Multiple Sclerosis
Enrolling
70 people
Starts
2025-01-21
Est. completion
2031-07
Design
Single-blind, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗