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
NYU Langone Health
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
- Age range
- 25–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Crite…
Interventions
- DeviceRemotely Supervised Transcranial Direct Current Stimulation (RS - tDCS)
tDCS is a noninvasive brain stimulation device that modulates brain activity delivering a low-intensity electrical current.
- DeviceRemotely Supervised Transcutaneous Auricular Vagus Nerve Stimulation (RS - taVNS)
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.
- DeviceRemotely Supervised Transcutaneous Cervical Vagus Nerve Stimulation (RS - tcVNS)
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.
Location
- NYU Langone HealthNew York, New York