Noninvasive Vagal Nerve Stimulation

NCT06816004 | Recruiting DMC FDA Device

• 1 other identifier: 24-01628
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

VNS; tDCS; Vagus Nerve Stimulation; Neuromodulation; Multiple Sclerosis; Home-Based

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants who Complete Home-Based taVNS or tcVNS Sessions

  Assessed among participants in the taVNS or tcVNS arms only.

  Up to Week 4 (End of Intervention)

Secondary Outcomes (12)

• Change in SymptoMScreen Score

  Baseline, Week 4 (End of Intervention)

• Change in Multiple Sclerosis Impact Scale (MSIS-29) Score

  Baseline, Week 4 (End of Intervention)

• Change in Memorial Symptom Assessment Scale (MSAS) Score

  Baseline, Week 4 (End of Intervention)

• Change in Kessler Psychological Distress Scale (K10) Score

  Baseline, Week 4 (End of Intervention)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score

  Baseline, Week 4 (End of Intervention)

Study Arms (3)

Active DLPFC tDCS

ACTIVE COMPARATOR

20 daily 20-minute sessions of active tDCS.

Device: Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS)

Active taVNS

EXPERIMENTAL

20 daily 60-minute sessions of active taVNS.

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

Active tcVNS

EXPERIMENTAL

20 daily 20-minute sessions of active tcVNS.

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

Interventions

Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS) DEVICE

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

Active DLPFC tDCS

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

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.

Active taVNS

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

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.

Active tcVNS

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10017, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Leigh Charvet, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shayna Pehel

CONTACT

929-455-5104; Shayna.Pehel@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: August 20, 2025
• Primary Completion: February 5, 2026
• Study Completion: May 5, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)