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Ear stimulation may help repair nerve damage in multiple sclerosis

NCT ID NCT06641271

Disease control Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study tests whether stimulating the vagus nerve through the ear, while doing a hand coordination task, can improve motor function in people with multiple sclerosis. Participants will receive either active or sham stimulation during 30-minute sessions over a month, with follow-up visits up to six months. The goal is to see if this approach is safe and can help the brain rewire or repair after demyelinating episodes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Closed Loop Trans-Auricular Vagus Nerve Stimulation System
What this could lead to
If it works, this could point toward a non-invasive way to improve motor function and possibly repair nerve damage in multiple sclerosis.
What could go wrong
This is an early feasibility study with only 70 participants, so results may not be conclusive. The intervention is experimental and may not provide benefit over sham stimulation.

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 70 people

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

Started

Jan 2025

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 70 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: * All participants ages 18-70 with diagnosis of multiple sclerosis at least 30 days from last relapse * Baseline grooved peg test time greater than or equal to 91 seconds for completion of the task (2 standard deviation above 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 Exclusion Criteria: * Current uncontrolled and/or clinically significant medical condition. * History of seizures or epilepsy. * Other central nervous system disease or significant brain trauma. * Bacterial or viral infection within the prior 30 days. * Prior treatment with total body irradiation, clemastine, bexarotene, or other experimental remyelinating agent. * Recent suicide attempt or continued expressed suicidal ideation. * Implanted devices, such as pacemakers, cochlear prosthesis, neuro-stimulators. * Abnormal ear anatomy or ear infection. * Pregnancy, lactation, or lack of use of contraception. * Unable to walk 25 feet continuously * Other significant disease or disorder that might impair study participation. Participants will be allowed to initiate or maintain background disease modifying therapy to reduce the risk of multiple sclerosis relapse and optimize recruitment.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

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

Multiple sclerosis Multiple sclerosis (MS) - relapsing-remitting

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Clinical Translational Research Center at CU Anschutz

    Aurora, Colorado, 80010, United States

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