RECRUITING

Noninvasive Vagal Nerve Stimulation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-05
Study Completion:2026-05-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06816004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * Age 25-65 years (inclusive)
  3. * Definite diagnosis of MS or related demyelinating disorders (e.g., Neuromyelitis Optica or NMO)
  4. * Stable high efficacy DMT ≥ 6 months before enrollment and throughout the trial
  5. * PDDS score ≤ 6 (established to be able to complete procedures)
  6. * SymptoMScreen Score ≥12
  7. * WRAT-5 ≥85
  8. * SDMT z-score \> -3.0
  9. * K10 \< 35
  10. * 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
  11. * Ability to use mobile devices
  1. * 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)
  2. * Diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS)
  3. * History of vagus nerve surgery/vagotomy
  4. * History of diagnosed cardiovascular disease, a heart transplant, presence of permanent pacemaker implant or Left Ventricular Assist Device
  5. * Use of certain medications that can affect heart rate variability, such as beta-blockers, calcium channel blockers, and cardiac glycosides
  6. * Use of SP1 inhibitor medications such as Fingolimod, Siponimod, Ozanimod, and Ponesimod
  7. * Nicotine use in the past 6 months (smoking/vaping)
  8. * Pregnant or planning pregnancy during the study period or breastfeeding
  9. * Seizure disorder or recent (\<5 years) seizure history
  10. * Active ear infections or ear pathology
  11. * Current presence of implanted vagus nerve stimulator or any other active implanted electronic devices (e.g., pacemaker, defibrillators, cochlear implants, DBS, iVNS, etc.)
  12. * Presence of metal objects in the head/neck
  13. * Any skin disorder or skin sensitive area near stimulation locations
  14. * BMI ≥ 35

Contacts and Locations

Study Contact

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

Principal Investigator

Leigh Charvet, PhD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10017
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Leigh Charvet, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-05
Study Completion Date2026-05-05

Study Record Updates

Study Start Date2025-02-05
Study Completion Date2026-05-05

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Multiple Sclerosis