Vagus Nerve Stimulation to Promote Remyelination in Multiple Sclerosis
University of Colorado, Denver
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * All participants ages 18-65 with diagnosis of multiple sclerosis at least 30 days from last relapse * Baseline grooved peg test time greater than or equal to 108 seconds for completion of the task (1 standard deviation below mean multiple sclerosis score). * Ability to sign informed consent * expanded disability status scale score (or estimated) of 2.5 or greater OR a clinical report of upper extremity dysfunction in their dominant hand Exclusion Criteria: * Current uncontrolled and/or clinically significant medical condition. * Primary progressive multiple sclerosis.…
Interventions
- DeviceClosed 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.
- DevicePlacebo
A closed-loop vagus nerve stimulation device that can deliver sham stimulation to the ear to simulate stimulation of the vagus nerve.
Location
- Clinical Translational Research Center at CU AnschutzAurora, Colorado