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

NCT06641271 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-07-06

No results posted yet for this study

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 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.

Conditions

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.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Jeffrey Bennett, MD · Anschutz Campus - School of Medicine - Neurology

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-21
Primary Completion
2031-07-31
Completion
2031-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06641271 on ClinicalTrials.gov