Multiple SclerosisVANISH-MSNCT06816004
Noninvasive Vagal Nerve Stimulation
A study testing Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS), Remotely Supervised Transcutaneous Auricular Vagus Nerve Stimulation (RS - taVNS) and Remotely Supervised Transcutaneous Cervical Vagus Nerve Stimulation (RS - tcVNS) in people with Multiple Sclerosis, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS), Remotely Supervised Transcutaneous Auricular Vagus Nerve Stimulation (RS - taVNS) and Remotely Supervised Transcutaneous Cervical Vagus Nerve Stimulation (RS - tcVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2025to 5 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Multiple Sclerosis
- Being 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)
- Keywords
- VNS, tDCS, Vagus Nerve Stimulation, Neuromodulation, Multiple Sclerosis, Home-Based
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS)Device
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)Device
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)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Active DLPFC tDCS | Active comparator | 20 daily 20-minute sessions of active tDCS. Receives: Device: Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS) |
| Active taVNS | Experimental | 20 daily 60-minute sessions of active taVNS. Receives: Device: Remotely Supervised Transcutaneous Auricular Vagus Nerve Stimulation (RS - taVNS) |
| Active tcVNS | Experimental | 20 daily 20-minute sessions of active tcVNS. Receives: Device: Remotely Supervised Transcutaneous Cervical Vagus Nerve Stimulation (RS - tcVNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who Complete Home-Based taVNS or tcVNS Sessions
Assessed among participants in the taVNS or tcVNS arms only.
Measured: Up to Week 4 (End of Intervention)
Secondary outcomes (12)
Change in SymptoMScreen Score
SymptoMScreen is a self-report tool to assess overall symptom burden.
Measured: Baseline, Week 4 (End of Intervention)
Change in Multiple Sclerosis Impact Scale (MSIS-29) Score
12-item self-report scale to assess symptom burden regarding neurological domains and the psychological impact of MS. Each item is rated on a 7-point Likert scale from 0 to 6. The item responses are summed to calculate a total score ranging from 0 to 72, with a higher score indicating more severe symptom limitations
Measured: Baseline, Week 4 (End of Intervention)
Change in Memorial Symptom Assessment Scale (MSAS) Score
32-item symptom self-report rating scale to better understand the symptom severity, symptom frequency, and distress from common symptoms. The total MSAS score is the average of the symptom scores for all 32 symptoms and ranges from 0 to 4. Higher scores indicate greater impact from symptoms.
Measured: Baseline, Week 4 (End of Intervention)
Change in Kessler Psychological Distress Scale (K10) Score
10-item questionnaire to assess psychological distress over a recent period of the past 4 weeks focusing on anxiety and depressive symptoms. Each item is rated on a 5-point Likert scale from 1-5. The total score is the sum of responses and ranges from 10-50; higher scores indicate more severe mental disorder.
Measured: Baseline, Week 4 (End of Intervention)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score
8-item qualitative self-report questionnaire regarding functions of sleep and wakefulness such as perceived sleep quality, sleep depth, and restfulness after sleep in the past 7 days. Each item is rated on a scale from 1-5. The total score is the sum of responses and ranges from 8-40; a higher score indicates more severe sleep disturbances.
Measured: Baseline, Week 4 (End of Intervention)
Change in PROMIS Fatigue - Short Form 7a Score
7-item self-report tool assessing fatigue severity and impact. Each item is rated on a scale from 1-5. The total score is the sum of responses and ranges from 7-35; higher scores indicate greater fatigue.
Measured: Baseline, Week 4 (End of Intervention)
Change in PROMIS Pain Intensity - Short Form 3a Score
3-item tool to evaluate quantitative participant experiences of pain intensity both over the past 7 days and at the time of completing the self-report assessment. Each item is rated on a scale from 1-5. The total score is the sum of responses and ranges from 3-15; higher scores indicate greater pain intensity.
Measured: Baseline, Week 4 (End of Intervention)
Change in General Anxiety Disorder (GAD-7) Score
7-item self-report questionnaire to screen for generalized anxiety in addition to assessing severity of anxiety symptoms. Each item is rated on a scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-21; higher scores indicate more prevalent symptoms of anxiety.
Measured: Baseline, Week 4 (End of Intervention)
Change in Composite Autonomic Symptom Score-31 (COMPASS-31) Score
31-item scale measuring autonomic symptoms in six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor functions. A total score from 0-100 is generated from the item responses; higher scores indicate more severe autonomic dysfunction.
Measured: Baseline, Week 4 (End of Intervention)
Change in Patient Health Questionnaire (PHQ-9) Score
9-item self-report questionnaire to screen for depressive disorder and furthermore, severity. Each item is rated on a scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-27; higher scores indicate greater severity of depressive symptoms.
Measured: Baseline, Week 4 (End of Intervention)
Change in Nine-Hole Peg Test (9HPT) Score
Assessment of manual dexterity and fine motor coordination in people with MS, using both dominant and non-dominant hands. The score is measured by the number of seconds it takes for a person to place and remove nine pegs from a pegboard, with a lower score (in seconds) indicating better dexterity and faster completion time.
Measured: Baseline, Week 4 (End of Intervention)
Change in Heart Rate Variability (HRV)
Assessed using the Chest Strap Polar H10 HR sensor.
Measured: Baseline, Week 4 (End of Intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start20 Aug 2025
- Primary completion5 Feb 2027 (estimated)
- Study completion5 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh Charvet, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816004
- Sponsor's protocol ID
- 24-01628
- Acronym
- VANISH-MS
- Status last verified
- May 2026
- First submitted
- 4 Feb 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06816004
- Acronym / sponsor ID
- VANISH-MS / 24-01628
- Conditions
- Multiple Sclerosis
- Keywords
- VNS, tDCS, Vagus Nerve Stimulation, Neuromodulation, Multiple Sclerosis, Home-Based
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 5 May 2027 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active DLPFC tDCS | Active comparator | Device: Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS)20 daily 20-minute sessions of active tDCS. |
| Active taVNS | Experimental | Device: Remotely Supervised Transcutaneous Auricular Vagus Nerve Stimulation (RS - taVNS)20 daily 60-minute sessions of active taVNS. |
| Active tcVNS | Experimental | Device: Remotely Supervised Transcutaneous Cervical Vagus Nerve Stimulation (RS - tcVNS)20 daily 20-minute sessions of active tcVNS. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Active DLPFC tDCS |
| 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. | Device | Active taVNS |
| 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. | Device | Active tcVNS |
Primary outcome
Percentage of Participants who Complete Home-Based taVNS or tcVNS Sessions
Time frame: Up to Week 4 (End of Intervention)
Assessed among participants in the taVNS or tcVNS arms only.
12 secondary outcomes
Change in SymptoMScreen Score
Time frame: Baseline, Week 4 (End of Intervention)
Change in Multiple Sclerosis Impact Scale (MSIS-29) Score
Time frame: Baseline, Week 4 (End of Intervention)
Change in Memorial Symptom Assessment Scale (MSAS) Score
Time frame: Baseline, Week 4 (End of Intervention)
Change in Kessler Psychological Distress Scale (K10) Score
Time frame: Baseline, Week 4 (End of Intervention)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score
Time frame: Baseline, Week 4 (End of Intervention)
Change in PROMIS Fatigue - Short Form 7a Score
Time frame: Baseline, Week 4 (End of Intervention)
Change in PROMIS Pain Intensity - Short Form 3a Score
Time frame: Baseline, Week 4 (End of Intervention)
Change in General Anxiety Disorder (GAD-7) Score
Time frame: Baseline, Week 4 (End of Intervention)
Change in Composite Autonomic Symptom Score-31 (COMPASS-31) Score
Time frame: Baseline, Week 4 (End of Intervention)
Change in Patient Health Questionnaire (PHQ-9) Score
Time frame: Baseline, Week 4 (End of Intervention)
Change in Nine-Hole Peg Test (9HPT) Score
Time frame: Baseline, Week 4 (End of Intervention)
Change in Heart Rate Variability (HRV)
Time frame: Baseline, Week 4 (End of Intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No. No plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leigh Charvet, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS), Remotely Supervised Transcutaneous Auricular Vagus Nerve Stimulation (RS - taVNS) and Remotely Supervised Transcutaneous Cervical Vagus Nerve Stimulation (RS - tcVNS) in people with Multiple Sclerosis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who Complete Home-Based taVNS or tcVNS Sessions (time frame: Up to Week 4 (End of Intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.