NCT06816004
Noninvasive Vagal Nerve Stimulation
Active, Not Recruiting
NAAges 25–65InterventionalNYU Langone HealthInvestigator-initiated
~30 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS)Remotely Supervised Transcutaneous Auricular Vagus Nerve Stimulation (RS - taVNS)Remotely Supervised Transcutaneous Cervical Vagus Nerve Stimulation (RS - tcVNS)
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants who Complete Home-Based taVNS or tcVNS Sessions
Measured over Up to Week 4 (End of Intervention)
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Leigh Charvet, PhD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Exclusion
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
What this trial measures
- Percentage of Participants who Complete Home-Based taVNS or tcVNS SessionsUp to Week 4 (End of Intervention)
Assessed among participants in the taVNS or tcVNS arms only.