Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-08-20
2026-05-05
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Active DLPFC tDCS
20 daily 20-minute sessions of active tDCS.
Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS)
tDCS is a noninvasive brain stimulation device that modulates brain activity delivering a low-intensity electrical current.
Active taVNS
20 daily 60-minute sessions of active taVNS.
Remotely 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.
Active tcVNS
20 daily 20-minute sessions of active tcVNS.
Remotely 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.
Interventions
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Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS)
tDCS is a noninvasive brain stimulation device that modulates brain activity delivering a low-intensity electrical current.
Remotely 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.
Remotely 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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
25 Years
65 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Leigh Charvet, PhD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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24-01628
Identifier Type: -
Identifier Source: org_study_id
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