Could a tiny neck implant help repair MS-damaged nerves?
NCT ID NCT06796504
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 7 times
Summary
This study tests a small device implanted on the vagus nerve in the neck to see if it can help repair myelin (the protective coating around nerves) in people with relapsing-remitting multiple sclerosis. About 60 adults aged 22–50 will take part. Two-thirds will receive active stimulation, and one-third will receive no stimulation at first, then switch to active after 48 weeks. The main goal is to check safety and any signs of nerve repair.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 22-60 years at informed consent. * Diagnosis of RRMS by revised 2017 McDonald criteria. * MS disease duration does not exceed 15 years from date of diagnosis at the time of informed consent * Latency delay \>116 milliseconds on baseline full-field transient pattern reversal visual evoked potential (VEP) in at least one eye. Both eyes can be included if they meet all inclusion criteria.Patients who do not meet the absolute P100 latency threshold of 116 ms in either eye will qualify if they have an inter-eye difference in P100 latency of \>6 ms * Peri-papillary retinal nerve fiber layer (pRNFL) \> 70 microns on Optical Coherence Topography (OCT) in the VEP-qualifying eye (sufficient axons). * Best corrected high-contrast (HCVA) better than 20/200 Snellen equivalent or letter score of 35 * Best corrected low-contrast letter acuity (LCLA) by Sloan chart (2.5% black on white) of no better than 40 letters in the VEP-qualifying eye (Snellen equivalent of 20/40). (Best corrected LCLA must be worse than best corrected HCVA.) * Absence of clinical relapse for at least 12 months prior to informed consent * No new lesions or increase in existing lesion volume on most recent clinic brain MRI (must be within 1 year of consent) * Taking a stable regimen of disease-modifying therapy (DMT) prior to informed consent. The DMT must have been started and maintained at least one year prior to consent. * Score of 2.5 to 6.5 by Expanded Disability Status Scale (EDSS) at baseline. Exclusion Criteria: * Confounding ophthalmologic disease or impairments/conditions that could interfere with visual testing (e.g., cataracts, disc hemorrhage, macular star, cotton wool spots, macular degeneration, glaucoma, diabetic and/or hypertensive retinopathy, history of detached retina, etc.) * Severe myopia defined as a refractive error of -6.00 diopters or more * Concurrent neurological disorders, including known moderate or severe cervical myelopathy. * Clinical optic neuritis within 6 months before screening. * Steroid treatment for MS symptoms in the 30 days prior to consent * Body Mass Index \>40 kg/m2 * Hypersensitivity/allergy to MRI contrast agents and/or unable to perform MRI (e.g., claustrophobia). * Regular use of or dependency on nicotine products within the past year. * Not a surgical candidate.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins School of Medicine
RECRUITINGBaltimore, Maryland, 21287, United States
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Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Minnesota Center for Multiple Sclerosis
RECRUITINGPlymouth, Minnesota, 55446, United States
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Shepherd Center
RECRUITINGAtlanta, Georgia, 30309, United States
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The University of Texas Health Science Center at Houston
RECRUITINGHouston, Texas, 77030, United States
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The University of Texas at Austin
RECRUITINGAustin, Texas, 78712, United States
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UW Medicine Multiple Sclerosis Center-Northwest
RECRUITINGSeattle, Washington, 98133, United States
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University of California Irvine Center for Clinical Research
RECRUITINGIrvine, California, 92617, United States
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West Virginia University
RECRUITINGMorgantown, West Virginia, 26506, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a common antihistamine boost multiple sclerosis treatment?
- Can Real-World data show how well multiple sclerosis patients stick with ofatumumab?
- Targeting hidden balance issues: a new therapy for early MS
- Can reading emotions explain social struggles in MS?
- Unlocking the Brain's role in relearning movement for MS patients