Multiple Sclerosis (MS) - Relapsing-remittingNCT06641271
Study to Investigate Vagus Nerve Stimulation Paired With Motor Task for Remyelination and Functional Recovery
A study testing Closed Loop Trans-Auricular Vagus Nerve Stimulation System in people with Multiple Sclerosis (MS) - Relapsing-remitting and Multiple Sclerosis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if stimulating the vagus nerve in combination with a motor task in people with multiple sclerosis can improve motor function. The main questions it aims to answer are: Is stimulating the vagus nerve safe and feasible after demyelinating episodes? Does a paired motor task… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis
- What is being tested?
- Closed Loop Trans-Auricular Vagus Nerve Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2025to Jul 2031
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants ages 18-70 with diagnosis of multiple sclerosis at least 30 days from last relapse
- Baseline grooved peg test time greater than or equal to 91 seconds for completion of the task (2 standard deviation above mean multiple sclerosis score).
- Ability to sign informed consent
- Expanded disability status scale score (or estimated) of 2.5 or greater OR a clinical report of upper extremity dysfunction in their dominant hand
Who cannot join
- Current uncontrolled and/or clinically significant medical condition.
- History of seizures or epilepsy.
- Other central nervous system disease or significant brain trauma.
- Bacterial or viral infection within the prior 30 days.
- Prior treatment with total body irradiation, clemastine, bexarotene, or other experimental remyelinating agent.
- Recent suicide attempt or continued expressed suicidal ideation.
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- Implanted devices, such as pacemakers, cochlear prosthesis, neuro-stimulators.
- Abnormal ear anatomy or ear infection.
- Pregnancy, lactation, or lack of use of contraception.
- Unable to walk 25 feet continuously
- Other significant disease or disorder that might impair study participation. Participants will be allowed to initiate or maintain background disease modifying therapy to reduce the risk of multiple sclerosis relapse and optimize recruitment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Clinical Translational Research Center at CU Anschutz
Aurora, Colorado, 80010
About this study
Official title: Vagus Nerve Stimulation to Promote Remyelination in Multiple Sclerosis
The goal of this clinical trial is to learn if stimulating the vagus nerve in combination with a motor task in people with multiple sclerosis can improve motor function. The main questions it aims to answer are:
- Is stimulating the vagus nerve safe and feasible after demyelinating episodes?
- Does a paired motor task with vagus nerve stimulation improve motor function with someone who has multiple sclerosis?
Read more
Researchers will compare active vagus nerve stimulation to a sham stimulation to see if the paired vagus nerve stimulation can improve motor control.
Participants will:
- Come in for study visits over a six month period. Study visits are three times weekly for the first month, then single follow up visits at two, three, and six months.
- During study visits, participants will complete 30 minutes of the paired vagus nerve stimulation with a motor task, specifically the grooved peg test.
- At various timepoints throughout the study, motor, disability, and neurophysiological assessments will be administered, including the Timed 25-Foot Walk Test, Expanded Disability Status Scale (EDSS), Upper Extremity portion of the Fugl-Meyer Assessment, Dellon-Modified Moberg Pick-Up Test, Multiple Sclerosis Impact Scale-29 (MSIS-29), motor evoked potentials (MEPs), and visual evoked potentials (VEPs). MRI assessments will also be performed to evaluate exploratory imaging metrics of potential remyelinative efficacy.
- Being tested
- Closed Loop Trans-Auricular Vagus Nerve Stimulation System, Placebo
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed Loop Trans-Auricular Vagus Nerve Stimulation SystemDevice
A closed loop system that delivers stimulation to the vagus nerve via the ear non-invasively following a trigger event.
PlaceboDevice
A closed-loop vagus nerve stimulation device that can deliver sham stimulation to the ear to simulate stimulation of the vagus nerve.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - Active Stimulation | Experimental | Participants in this arm will receive active stimulation during the paired motor task. Receives: Device: Closed Loop Trans-Auricular Vagus Nerve Stimulation System |
| Control - Sham Stimulation | Sham comparator | Participants in this arm will receive sham stimulation during the paired motor task to create a control to the experimental group. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events in response to paired-taVNS treatment
The frequency of adverse events (AEs) or serious adverse events (SAEs) will be monitored during the 6-month paired-taVNS treatment to measure the safety and tolerance of the intervention.
Measured: End of Study (6 months)
Secondary outcomes (9)
Change from baseline in time to complete the grooved peg test
The participant will complete the grooved peg test with their dominant hand and will be timed while doing so. The change in time to completion will be tracked over the study.
Measured: End of Study (6 months)
Change from baseline of score of the upper extremity portion of the Fugl-Meyer Assessment
The upper extremity portion of the Fugl-Meyer assessment evaluates movements of the upper limbs with score ranging from 0 - 66. A higher score indicates more function.
Measured: End of Study (6 months)
Change from baseline score of the Expanded Disability Status Scale
The expanded disability status scale scores range from 0 - 10, where 10 indicates full function.
Measured: End of Study (6 months)
Change in time from baseline to complete the timed 25 foot walk test
The timed 25 foot walk test is a performance measure where the participants walks 25 feet unassisted and the time to completion is recorded.
Measured: End of Study (6 months)
Change from baseline in composite disability metric
The fraction of participants in each intervention group at 6 months with improvement in disability will be determined by a composite disability metric composed of three elements: expanded disability status scale, timed 25 foot walk, and grooved peg test time. The metric will be deemed positive if there is a significant change in one or more of the measures as determined as follows: 1) decrease in expanded disability status scale score of 1 point (baseline expanded disability status scale score ≤5.5) or 0.5 point (baseline expanded disability status scale score of >5.5); 2) 20% decrease in timed 25 foot walk test; or 3) 25% decrease in grooved peg test time. The composite disability metric will be quantified by a trained study personnel.
Measured: End of Study (6 months)
Change in Dellon-Modified Moberg Pick-Up Test
Dellon-Modified Moberg Pick-Up Test (DMMPUT) is a test requiring the pickup of small objects commonly used in everyday life. The change in time for completion will be tracked for the duration of the study.
Measured: End of Study (6 months)
Change from baseline in patient reported outcomes from the multiple sclerosis impact scale 29
The Multiple Sclerosis Impact Scale - 29 is a 29-item patient-reported measure of the physical and psychological impacts of multiple sclerosis. Participants are asked to rate how much their functioning and well-being has been impacted over the past 14 days on a 4-point scale. Higher scores indicate a greater disease impact.
Measured: End of Study (6 months)
Motor Evoked Potential
The Motor Evoked Potential will evaluate conduction through the corticospinal pathways.
Measured: End of Study (6 months)
Visual Evoked Potential
The Visual Evoked Potential will evaluate conduction through the visual pathways.
Measured: End of Study (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start21 Jan 2025
- Primary completionJul 2031 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS) - Relapsing-remittingStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Bennett, MD, Principal investigator, Anschutz Campus - School of Medicine - Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641271
- Sponsor's protocol ID
- 22-1451
- Status last verified
- Jul 2026
- First submitted
- 11 Oct 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagus Nerve Stimulation to Promote Remyelination in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06641271
- Acronym / sponsor ID
- 22-1451
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- Jul 2031 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 15 Oct 2024 (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.
The goal of this clinical trial is to learn if stimulating the vagus nerve in combination with a motor task in people with multiple sclerosis can improve motor function. The main questions it aims to answer are:
- Is stimulating the vagus nerve safe and feasible after demyelinating episodes?
- Does a paired motor task with vagus nerve stimulation improve motor function with someone who has multiple sclerosis?
Researchers will compare active vagus nerve stimulation to a sham stimulation to see if the paired vagus nerve stimulation can improve motor control.
Participants will:
- Come in for study visits over a six month period. Study visits are three times weekly for the first month, then single follow up visits at two, three, and six months.
- During study visits, participants will complete 30 minutes of the paired vagus nerve stimulation with a motor task, specifically the grooved peg test.
- At various timepoints throughout the study, motor, disability, and neurophysiological assessments will be administered, including the Timed 25-Foot Walk Test, Expanded Disability Status Scale (EDSS), Upper Extremity portion of the Fugl-Meyer Assessment, Dellon-Modified Moberg Pick-Up Test, Multiple Sclerosis Impact Scale-29 (MSIS-29), motor evoked potentials (MEPs), and visual evoked potentials (VEPs). MRI assessments will also be performed to evaluate exploratory imaging metrics of potential remyelinative efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental - Active Stimulation | Experimental | Device: Closed Loop Trans-Auricular Vagus Nerve Stimulation SystemParticipants in this arm will receive active stimulation during the paired motor task. |
| Control - Sham Stimulation | Sham comparator | Device: PlaceboParticipants in this arm will receive sham stimulation during the paired motor task to create a control to the experimental group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All participants ages 18-70 with diagnosis of multiple sclerosis at least 30 days from last relapse
- Baseline grooved peg test time greater than or equal to 91 seconds for completion of the task (2 standard deviation above mean multiple sclerosis score).
- Ability to sign informed consent
- Expanded disability status scale score (or estimated) of 2.5 or greater OR a clinical report of upper extremity dysfunction in their dominant hand
Key exclusion criteria (11 listed)
- Current uncontrolled and/or clinically significant medical condition.
- History of seizures or epilepsy.
- Other central nervous system disease or significant brain trauma.
- Bacterial or viral infection within the prior 30 days.
- Prior treatment with total body irradiation, clemastine, bexarotene, or other experimental remyelinating agent.
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 |
|---|---|---|
| Closed Loop Trans-Auricular Vagus Nerve Stimulation SystemA closed loop system that delivers stimulation to the vagus nerve via the ear non-invasively following a trigger event. | Device | Experimental - Active Stimulation |
| PlaceboA closed-loop vagus nerve stimulation device that can deliver sham stimulation to the ear to simulate stimulation of the vagus nerve. | Device | Control - Sham Stimulation |
Primary outcome
Frequency of adverse events in response to paired-taVNS treatment
Time frame: End of Study (6 months)
The frequency of adverse events (AEs) or serious adverse events (SAEs) will be monitored during the 6-month paired-taVNS treatment to measure the safety and tolerance of the intervention.
9 secondary outcomes
Change from baseline in time to complete the grooved peg test
Time frame: End of Study (6 months)
Change from baseline of score of the upper extremity portion of the Fugl-Meyer Assessment
Time frame: End of Study (6 months)
Change from baseline score of the Expanded Disability Status Scale
Time frame: End of Study (6 months)
Change in time from baseline to complete the timed 25 foot walk test
Time frame: End of Study (6 months)
Change from baseline in composite disability metric
Time frame: End of Study (6 months)
Change in Dellon-Modified Moberg Pick-Up Test
Time frame: End of Study (6 months)
Change from baseline in patient reported outcomes from the multiple sclerosis impact scale 29
Time frame: End of Study (6 months)
Motor Evoked Potential
Time frame: End of Study (6 months)
Visual Evoked Potential
Time frame: End of Study (6 months)
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 6 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Jeffrey Bennett, MD principal investigator
Anschutz Campus - School of Medicine - Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed Loop Trans-Auricular Vagus Nerve Stimulation System in people with Multiple Sclerosis (MS) - Relapsing-remitting and Multiple Sclerosis, run by University of Colorado, Denver 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 4 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 6 Jul 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. Some participants in this study may receive a placebo. 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?
Frequency of adverse events in response to paired-taVNS treatment (time frame: End of Study (6 months)). 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 6 Jul 2026.