Noninvasive Vagal Nerve Stimulation

Last updated: February 7, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Memory Loss

Neurologic Disorders

Treatment

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

Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS)

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

Clinical Study ID

NCT06816004
24-01628
  • Ages 25-65
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female

  • Age 25-65 years (inclusive)

  • Definite diagnosis of MS or related demyelinating disorders (e.g., NeuromyelitisOptica 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 relapseor confirmed radiologic disease activity, or more than 1 month after steroidtreatment

  • Ability to use mobile devices

Exclusion

Exclusion Criteria:

  • Primary neurologic disorder other than MS and related demyelinating disorders likeNMO (e.g., stroke, Parkinson's disease, spinal cord injury, intracranial mass,traumatic brain injury (TBI), epilepsy, mild cognitive impairment (MCI), ordementia), psychiatric disorders or major medical disorders (e.g., history ofmyocardial 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 ofpermanent pacemaker implant or Left Ventricular Assist Device

  • Use of certain medications that can affect heart rate variability, such asbeta-blockers, calcium channel blockers, and cardiac glycosides

  • Use of SP1 inhibitor medications such as Fingolimod, Siponimod, Ozanimod, andPonesimod

  • 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 implantedelectronic 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

Study Design

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Remotely Supervised Transcutaneous Auricular Vagus Nerve Stimulation (RS - taVNS)
Phase:
Study Start date:
February 05, 2025
Estimated Completion Date:
May 05, 2026

Connect with a study center

  • NYU Langone Health

    New York, New York 10017
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.