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RecruitingNot ApplicableNCT06816004

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

Sponsor

NYU Langone Health

Enrollment

30 participants

Start Date

Aug 20, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis

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.

Eligibility

Min Age: 25 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a non-invasive vagus nerve stimulation device in women with multiple sclerosis (MS) or a related nerve condition (like neuromyelitis optica). The vagus nerve runs from the brain through the body and plays a role in regulating many body functions. Researchers want to see if gentle electrical stimulation of this nerve through the ear can help reduce MS symptoms such as fatigue and cognitive difficulties. **You may be eligible if...** - You are female, between 25 and 65 years old - You have a confirmed diagnosis of MS or a related demyelinating disorder - You have been on a stable high-efficacy MS disease-modifying treatment for at least 6 months - You are experiencing significant MS symptoms (based on symptom scores) - You can use a mobile device **You may NOT be eligible if...** - You have another primary neurological disorder (e.g., stroke, Parkinson's, spinal cord injury) - Your MS has been recently active (relapse or new lesions within the past month) - You have severe depression or significant cognitive impairment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERemotely Supervised Transcranial Direct Current Stimulation (RS - tDCS)

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

DEVICERemotely 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.

DEVICERemotely 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.

Locations(1)

NYU Langone Health

New York, New York, United States

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NCT06816004

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