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Could a tiny neck implant help repair MS-damaged nerves?

NCT ID NCT06796504

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 7 times

Summary

This study tests a small device implanted on the vagus nerve in the neck to see if it can help repair myelin (the protective coating around nerves) in people with relapsing-remitting multiple sclerosis. About 60 adults aged 22–50 will take part. Two-thirds will receive active stimulation, and one-third will receive no stimulation at first, then switch to active after 48 weeks. The main goal is to check safety and any signs of nerve repair.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 22-60 years at informed consent. * Diagnosis of RRMS by revised 2017 McDonald criteria. * MS disease duration does not exceed 15 years from date of diagnosis at the time of informed consent * Latency delay \>116 milliseconds on baseline full-field transient pattern reversal visual evoked potential (VEP) in at least one eye. Both eyes can be included if they meet all inclusion criteria.Patients who do not meet the absolute P100 latency threshold of 116 ms in either eye will qualify if they have an inter-eye difference in P100 latency of \>6 ms * Peri-papillary retinal nerve fiber layer (pRNFL) \> 70 microns on Optical Coherence Topography (OCT) in the VEP-qualifying eye (sufficient axons). * Best corrected high-contrast (HCVA) better than 20/200 Snellen equivalent or letter score of 35 * Best corrected low-contrast letter acuity (LCLA) by Sloan chart (2.5% black on white) of no better than 40 letters in the VEP-qualifying eye (Snellen equivalent of 20/40). (Best corrected LCLA must be worse than best corrected HCVA.) * Absence of clinical relapse for at least 12 months prior to informed consent * No new lesions or increase in existing lesion volume on most recent clinic brain MRI (must be within 1 year of consent) * Taking a stable regimen of disease-modifying therapy (DMT) prior to informed consent. The DMT must have been started and maintained at least one year prior to consent. * Score of 2.5 to 6.5 by Expanded Disability Status Scale (EDSS) at baseline. Exclusion Criteria: * Confounding ophthalmologic disease or impairments/conditions that could interfere with visual testing (e.g., cataracts, disc hemorrhage, macular star, cotton wool spots, macular degeneration, glaucoma, diabetic and/or hypertensive retinopathy, history of detached retina, etc.) * Severe myopia defined as a refractive error of -6.00 diopters or more * Concurrent neurological disorders, including known moderate or severe cervical myelopathy. * Clinical optic neuritis within 6 months before screening. * Steroid treatment for MS symptoms in the 30 days prior to consent * Body Mass Index \>40 kg/m2 * Hypersensitivity/allergy to MRI contrast agents and/or unable to perform MRI (e.g., claustrophobia). * Regular use of or dependency on nicotine products within the past year. * Not a surgical candidate.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Johns Hopkins School of Medicine

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Minnesota Center for Multiple Sclerosis

    RECRUITING

    Plymouth, Minnesota, 55446, United States

  • Shepherd Center

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • The University of Texas at Austin

    RECRUITING

    Austin, Texas, 78712, United States

  • UW Medicine Multiple Sclerosis Center-Northwest

    RECRUITING

    Seattle, Washington, 98133, United States

  • University of California Irvine Center for Clinical Research

    RECRUITING

    Irvine, California, 92617, United States

  • West Virginia University

    RECRUITING

    Morgantown, West Virginia, 26506, United States

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