Noninvasive Vagal Nerve Stimulation for the Management of Symptoms Experienced in Multiple Sclerosis (VANISH-MS): An Open-Label Home-Based Study of taVNS and tcVNS Compared to tDCS

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Multiple Sclerosis
  • Age: Between 25 Year(s) - 65 Year(s)
  • Gender: Female
  • Other Inclusion Criteria:
    1. Female
    2. Age 25-65 years (inclusive)
    3. Definite diagnosis of multiple sclerosis (MS) or related demyelinating disorders (e.g., Neuromyelitis Optica or NMO)
    4. 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
    5. Stable high efficacy disease modifying therapy (DMT) ≥ 6 months prior to enrollment and throughout the trial
    6. Ability to use mobile devices

You may not be eligible for this study if the following are true:

    1. 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)
    2. Diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS)
    3. History of vagus nerve surgery/vagotomy
    4. History of diagnosed cardiovascular disease, a heart transplant, presence of permanent pacemaker implant or Left Ventricular Assist Device
    5. Use of certain medications that can affect heart rate variability, such as beta-blockers, calcium channel blockers, and cardiac glycosides
    6. Use of SP1 inhibitor medications such as Fingolimod, Siponimod, Ozanimod, and Ponesimod
    7. Nicotine use in the past 6 months (smoking/vaping)
    8. Pregnant or planning pregnancy during the study period or breastfeeding
    9. Seizure disorder or recent (<5 years) seizure history
    10. Active ear infections or ear pathology
    11. Current presence of implanted vagus nerve stimulator or any other active implanted electronic devices (e.g., pacemaker, defibrillators, cochlear implants, DBS, iVNS, etc.)
    12. Presence of metal objects in the head/neck
    13. Any skin disorder or skin sensitive area near stimulation locations
    14. BMI ≥ 35



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