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RECRUITING
NCT06641271
NA

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

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

Summary

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 in the study, motor and disability tests will be administered to see if there are any changes in motor control for that participants. These tests include the timed 25 foot walk test, expanded disability scale, the upper extremity portion of the Fugl-Meyer Assessment, and the Multiple Sclerosis Impact Scale - 29.

Official title: Vagus Nerve Stimulation to Promote Remyelination in Multiple Sclerosis

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2025-01-21

Completion Date

2027-11

Last Updated

2025-03-14

Healthy Volunteers

No

Interventions

DEVICE

Closed Loop Trans-Auricular Vagus Nerve Stimulation System

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

DEVICE

Placebo

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

Locations (1)

Clinical Translational Research Center at CU Anschutz

Aurora, Colorado, United States