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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06641271
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Closed Loop Trans-Auricular Vagus Nerve Stimulation System — DEVICE
    A closed loop system that delivers stimulation to the vagus nerve via the ear non-invasively following a trigger event.
  • Placebo — DEVICE
    A closed-loop vagus nerve stimulation device that can deliver sham stimulation to the ear to simulate stimulation of the vagus nerve.

Study Details

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.

Key Dates

First listed
Oct 15, 2024
Start date
Jan 21, 2025
Status verified
Jul 2026
Primary completion
Jul 31, 2031
Completion
Jul 31, 2031

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Frequency of adverse events in response to paired-taVNS treatment [ Time Frame: End of Study (6 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Translational Research Center at CU AnschutzAuroraColorado80010-

Find similar trials in Aurora, CO

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Clinical Translational Research Center at CU Anschutz· Aurora, CO

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