NCT06816004

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-20
• Primary completion: 2026-02-05
• Completion: 2026-05-05
• First posted: 2025-02-10
• Last updated: 2025-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study