Noninvasive vagal nerve stimulation for managing multiple sclerosis symptoms
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
This study is testing if noninvasive vagal nerve stimulation can help reduce symptoms in people with multiple sclerosis compared to a standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06816004 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effectiveness of noninvasive vagal nerve stimulation (VNS) techniques, specifically transcutaneous auricular and cervical VNS, compared to a standard intervention of transcranial direct current stimulation (tDCS) in patients with multiple sclerosis. The primary focus is on assessing feasibility and gathering preliminary efficacy data related to symptom reduction. Participants will be monitored for changes in heart rate variability as a biomarker for VNS response. The findings aim to inform the design of a larger randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates are females aged 25-65 with a confirmed diagnosis of multiple sclerosis or related demyelinating disorders who are stable on high-efficacy disease-modifying therapies.
Not a fit: Patients with primary neurologic disorders other than MS, significant psychiatric disorders, or major medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly alleviate the symptom burden associated with multiple sclerosis, enhancing patients' overall well-being.
How similar studies have performed: Other studies have shown promise with vagal nerve stimulation approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Leigh Charvet, PhD — NYU Langone Health
- Study coordinator: Shayna Pehel
- Email: Shayna.Pehel@nyulangone.org
- Phone: 929-455-5104
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.