An interventional study of Closed Loop Trans-Auricular Vagus Nerve Stimulation System and Placebo in Multiple Sclerosis (MS) - Relapsing-remitting and Multiple Sclerosis, sponsored by University of Colorado, Denver. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Supportive care
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:
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:
602 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 80 are open to participants now.
This study's planned enrollment of 70 is close to the median of 72 across 429 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this arm will receive active stimulation during the paired motor task.
Device: Closed Loop Trans-Auricular Vagus Nerve Stimulation System
Participants in this arm will receive sham stimulation during the paired motor task to create a control to the experimental group.
Device: Placebo
A closed loop system that delivers stimulation to the vagus nerve via the ear non-invasively following a trigger event.
A closed-loop vagus nerve stimulation device that can deliver sham stimulation to the ear to simulate stimulation of the vagus nerve.
Frequency of adverse events in response to paired-taVNS treatment
The frequency of adverse events (AEs) or serious adverse events (SAEs) will be monitored during the 6-month paired-taVNS treatment to measure the safety and tolerance of the intervention.
Time frame: End of Study (6 months)
Change from baseline in time to complete the grooved peg test
The participant will complete the grooved peg test with their dominant hand and will be timed while doing so. The change in time to completion will be tracked over the study.
Time frame: End of Study (6 months)
Change from baseline of score of the upper extremity portion of the Fugl-Meyer Assessment
The upper extremity portion of the Fugl-Meyer assessment evaluates movements of the upper limbs with score ranging from 0 - 66. A higher score indicates more function.
Time frame: End of Study (6 months)
Change from baseline score of the Expanded Disability Status Scale
The expanded disability status scale scores range from 0 - 10, where 10 indicates full function.
Time frame: End of Study (6 months)
Change in time from baseline to complete the timed 25 foot walk test
The timed 25 foot walk test is a performance measure where the participants walks 25 feet unassisted and the time to completion is recorded.
Time frame: End of Study (6 months)
Change from baseline in composite disability metric
The fraction of participants in each intervention group at 6 months with improvement in disability will be determined by a composite disability metric composed of three elements: expanded disability status scale, timed 25 foot walk, and grooved peg test time. The metric will be deemed positive if there is a significant change in one or more of the measures as determined as follows: 1) decrease in expanded disability status scale score of 1 point (baseline expanded disability status scale score ≤5.5) or 0.5 point (baseline expanded disability status scale score of \>5.5); 2) 20% decrease in timed 25 foot walk test; or 3) 25% decrease in grooved peg test time. The composite disability metric will be quantified by a trained study personnel.
Time frame: End of Study (6 months)
Change in Dellon-Modified Moberg Pick-Up Test
Dellon-Modified Moberg Pick-Up Test (DMMPUT) is a test requiring the pickup of small objects commonly used in everyday life. The change in time for completion will be tracked for the duration of the study.
Time frame: End of Study (6 months)
Change from baseline in patient reported outcomes from the multiple sclerosis impact scale 29
The Multiple Sclerosis Impact Scale - 29 is a 29-item patient-reported measure of the physical and psychological impacts of multiple sclerosis. Participants are asked to rate how much their functioning and well-being has been impacted over the past 14 days on a 4-point scale. Higher scores indicate a greater disease impact.
Time frame: End of Study (6 months)
Motor Evoked Potential
The Motor Evoked Potential will evaluate conduction through the corticospinal pathways.
Time frame: End of Study (6 months)
Visual Evoked Potential
The Visual Evoked Potential will evaluate conduction through the visual pathways.
Time frame: End of Study (6 months)
Change in mean magnetization transfer resonance (MTR) signal in white matter (WM) lesions from baseline to 6 months
Changes in MTR will be evaluated as an exploratory imaging measure of tissue repair and remyelination.
Time frame: End of Study (6 months)
Change in the 25th percentile of the normalized proton density-weighted MRI lesion signal (nPD2574) from baseline to 6 months
Changes in nPD25 will be evaluated as an exploratory imaging measure of tissue repair and remyelination.
Time frame: End of Study (6 months)
Plan to share: No
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Multiple Sclerosis, Relapsing-Remitting→
University of Colorado, Denver