Actively Recruiting
Noninvasive Vagal Nerve Stimulation
Led by NYU Langone Health · Updated on 2025-08-26
30
Participants Needed
1
Research Sites
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Noninvasive Vagal Nerve Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Age 25 to 65 years (inclusive)
- Definite diagnosis of multiple sclerosis or related demyelinating disorders such as Neuromyelitis Optica
- Stable high efficacy disease-modifying therapy for at least 6 months before enrollment and throughout the trial
- PDDS score of 6 or lower indicating ability to complete procedures
- SymptoMScreen score of 12 or higher
- WRAT-5 score of 85 or higher
- SDMT z-score greater than -3.0
- K10 score less than 35
- Stable disease activity, defined as more than 1 month after clinical relapse, confirmed radiologic activity, or steroid treatment
- Ability to use mobile devices
You will not qualify if you...
- Primary neurologic disorders other than MS or related demyelinating disorders (e.g., stroke, Parkinson's disease, spinal cord injury, intracranial mass, traumatic brain injury, epilepsy, mild cognitive impairment, or dementia)
- Psychiatric disorders or major medical disorders such as history of myocardial infarction, diabetes, thyroid disease, arrhythmia, or atrial fibrillation
- Diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS)
- History of vagus nerve surgery or vagotomy
- History of cardiovascular disease, heart transplant, permanent pacemaker, or Left Ventricular Assist Device
- Use of medications affecting heart rate variability like beta-blockers, calcium channel blockers, and cardiac glycosides
- Use of SP1 inhibitor medications such as Fingolimod, Siponimod, Ozanimod, and Ponesimod
- Nicotine use (smoking or vaping) in the past 6 months
- Pregnant, planning pregnancy during the study, or breastfeeding
- Seizure disorder or seizure history within the past 5 years
- Active ear infections or ear pathology
- Presence of implanted vagus nerve stimulator or other implanted electronic devices (e.g., pacemaker, defibrillator, cochlear implant, DBS, iVNS)
- Presence of metal objects in the head or neck
- Skin disorders or sensitive skin near stimulation sites
- Body mass index (BMI) of 35 or higher
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10017
Actively Recruiting
Research Team
S
Shayna Pehel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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