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Study to Investigate Vagus Nerve Stimulation Paired With Motor Task for Remyelination and Functional Recovery

University of Colorado, Denver · 2025
ClinicalTrials.gov · Datasets · License: Public Domain · 2025
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multiple-sclerosisna
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.
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