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Nerve-Zapping gadget could tame MS symptoms at home

NCT ID NCT06816004

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests if a gentle, non-invasive nerve stimulation device can help manage symptoms of multiple sclerosis (MS), like fatigue and pain. Thirty women with MS will use the device at home for a few weeks. The goal is to see if it's practical and if it reduces symptom burden, potentially by calming inflammation and stress.

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 30 people

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

Started

Aug 2025

Expected to finish

May 2027

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

25 to 65 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: * Female * Age 25-65 years (inclusive) * Definite diagnosis of MS or related demyelinating disorders (e.g., Neuromyelitis Optica or NMO) * Stable high efficacy DMT ≥ 6 months before enrollment and throughout the trial * PDDS score ≤ 6 (established to be able to complete procedures) * SymptoMScreen Score ≥12 * WRAT-5 ≥85 * SDMT z-score \> -3.0 * K10 \< 35 * Stable disease activity, defined as being more than 1 month after a clinical relapse or confirmed radiologic disease activity, or more than 1 month after steroid treatment * Ability to use mobile devices Exclusion Criteria: * Primary neurologic disorder other than MS and related demyelinating disorders like NMO (e.g., stroke, Parkinson's disease, spinal cord injury, intracranial mass, traumatic brain injury (TBI), epilepsy, mild cognitive impairment (MCI), or dementia), psychiatric disorders or major medical disorders (e.g., history of myocardial infarction, diabetes, thyroid disease, arrhythmia, atrial fibrillation) * Diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS) * History of vagus nerve surgery/vagotomy * History of diagnosed cardiovascular disease, a heart transplant, presence of permanent pacemaker implant or Left Ventricular Assist Device * Use of certain medications that can affect heart rate variability, such as beta-blockers, calcium channel blockers, and cardiac glycosides * Use of SP1 inhibitor medications such as Fingolimod, Siponimod, Ozanimod, and Ponesimod * Nicotine use in the past 6 months (smoking/vaping) * Pregnant or planning pregnancy during the study period or breastfeeding * Seizure disorder or recent (\<5 years) seizure history * Active ear infections or ear pathology * Current presence of implanted vagus nerve stimulator or any other active implanted electronic devices (e.g., pacemaker, defibrillators, cochlear implants, DBS, iVNS, etc.) * Presence of metal objects in the head/neck * Any skin disorder or skin sensitive area near stimulation locations * BMI ≥ 35

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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.

Contacts and locations

Locations

  • NYU Langone Health

    New York, New York, 10017, United States

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Other studies related to the condition(s) this trial covers.