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Noninvasive Vagal Nerve Stimulation

NCT06816004 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Leigh Charvet, PhD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2026-02-05
Completion
2026-05-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06816004 on ClinicalTrials.gov