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Nerve-Zapping gadget could tame MS symptoms at home
NCT ID NCT06816004
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
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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
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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25 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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NYU Langone Health
New York, New York, 10017, United States
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Other studies related to the condition(s) this trial covers.
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