Vagus Nerve Stimulation to Promote Remyelination in Multiple Sclerosis

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Colorado
Clinical Translational Research Center at CU Anschutz
RECRUITING
Aurora
Contact Information
Primary
Adrienne Ellett, MS
adrienne.ellett@cuanschutz.edu
7204280944
Backup
Pamela David Gerecht
pamela.davidgerecht@cuanschutz.edu
(303)724-4134
Time Frame
Start Date: 2025-01-21
Estimated Completion Date: 2027-11
Participants
Target number of participants: 70
Treatments
Experimental: Experimental - Active Stimulation
Participants in this arm will receive active stimulation during the paired motor task.
Sham_comparator: Control - Sham Stimulation
Participants in this arm will receive sham stimulation during the paired motor task to create a control to the experimental group.
Related Therapeutic Areas
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov