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RECRUITING

NCT06816004

Noninvasive Vagal Nerve Stimulation

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

25 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-08-20

Completion Date

2026-05-05

Last Updated

2025-08-26

Healthy Volunteers

Conditions

Multiple Sclerosis

Interventions

DEVICE

Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS)

tDCS is a noninvasive brain stimulation device that modulates brain activity delivering a low-intensity electrical current.

DEVICE

Remotely Supervised Transcutaneous Auricular Vagus Nerve Stimulation (RS - taVNS)

taVNS is a noninvasive peripheral nerve stimulation device that modulates vagus nerve activity delivering a low-intensity electrical current (\< 5mA) through hydrogel electrodes to the left auricular branch of the vagus nerve.

DEVICE

Remotely Supervised Transcutaneous Cervical Vagus Nerve Stimulation (RS - tcVNS)

tcVNS is a noninvasive peripheral nerve stimulation device that modulates vagus nerve activity delivering a low-intensity electrical current (\< 5mA) through cervical hydrogel electrodes to the left cervical branch of the vagus nerve.

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

Locations (1)

NYU Langone Health

New York, New York, United States

Clinical Research Directory

Noninvasive Vagal Nerve Stimulation

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)