NCT06816004Active, not recruiting
Noninvasive Vagal Nerve Stimulation
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
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
Growing evidence suggests that vagal nerve stimulation (VNS) may be novel and effective in the management of the symptom burden of multiple sclerosis (MS) potentially by reducing inflammation and emotional distress, therefore improving overall well-being. We will complete a pilot study comparing transcutaneous auricular vagus nerve stimulation (taVNS) and transcutaneous cervical vagus nerve stimulation (tcVNS) to a standard intervention of dorsolateral prefrontal cortex (DLPFC) transcranial direct current stimulation (tDCS) as an active control. The primary outcome will be feasibility and the preliminary efficacy data concerning self-reported symptom reduction to inform the design of an intervention, and estimated power needed to complete a larger sham-controlled RCT. We will also measure heart rate variability (HRV), an easily obtained biomarker of vagus nerve stimulation (VNS), in correspondence to intervention response.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 4 Feb 2025
- Start date
- 20 Aug 2025
- Primary completion date
- 5 Feb 2027
- Lead sponsor
- NYU Langone Health
- Diseases
- Multiple sclerosis
- NCT number
- NCT06816004
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 20 Aug 2025 to the primary completion date, 5 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of SP1 inhibitor medications such as Fingolimod, Siponimod, Ozanimod, and Ponesimod
- Current presence of implanted vagus nerve stimulator or any other active implanted electronic devices (e.g., pacemaker, defibrillators, cochlear implants, DBS, iVNS, etc.)
Other illness
- 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
- Active ear infections or ear pathology
- Any skin disorder or skin sensitive area near stimulation locations
Lab values
- Use of certain medications that can affect heart rate variability, such as beta-blockers, calcium channel blockers, and cardiac glycosides
Age
- Seizure disorder or recent (\<5 years) seizure history
Other
- Nicotine use in the past 6 months (smoking/vaping)
- Pregnant or planning pregnancy during the study period or breastfeeding
- Presence of metal objects in the head/neck
- BMI ≥ 35
Who the study is looking for
- 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
Age in the registry: 25 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.