SetPoint implant to promote remyelination in relapsing-remitting MS
The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study
This study will try a small implanted vagus-nerve stimulator alongside standard MS treatments to promote remyelination in adults with relapsing-remitting MS.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 22 Years to 50 Years |
| Sex | All |
| Sponsor | SetPoint Medical Corporation Industry-sponsored |
| Locations | 5 sites (Atlanta, Georgia and 4 other locations) |
| Trial ID | NCT06796504 on ClinicalTrials.gov |
What this trial studies
This is a randomized 2:1, double-blind, sham-controlled pilot enrolling up to 60 adults with relapsing-remitting MS at multiple U.S. centers. All participants receive a surgical implant on the left vagus nerve and continue their usual disease-modifying therapy; two-thirds get daily active stimulation and one-third get non-active (sham) stimulation for 48 weeks. Stimulation is delivered for 1 minute once per day, with blinded Week 48 evaluations followed by a one-way crossover of controls to active stimulation and a 48-week open-label safety follow-up. Eligibility targets adults 22–50 years old with specific visual pathway biomarkers (delayed VEP and preserved retinal nerve fiber layer) and stable MRI and clinical status prior to enrollment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22–50 with relapsing-remitting MS who have prolonged visual evoked potential latency (>118 ms) with sufficient retinal nerve fiber layer thickness (>70 µm), reduced low-contrast visual acuity, no relapse for ≥12 months, and no new or enlarging brain MRI lesions within the past year.
Not a fit: People with progressive MS, recent relapses or new MRI activity, very thin retinal nerve fiber layer (insufficient axons), outside the 22–50 age range, or who cannot undergo implant surgery are unlikely to benefit from this study intervention.
Why it matters
Potential benefit: If successful, the implant could promote remyelination and improve or stabilize visual pathway function in selected people with relapsing-remitting MS.
How similar studies have performed: Neuromodulation and vagus nerve stimulation have shown immunomodulatory effects in early research, but clinical evidence for promoting remyelination in MS is limited, making this a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 22-50 years at informed consent. * Diagnosis of RRMS by revised 2017 McDonald criteria. * Latency delay \>118 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. * 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. If intermediate-potency DMT, the DMT must have been started and maintained for at least two years prior to consent. If high-potency DMT, the DMT must have been started and maintained at least one year prior to consent. * Score of 2.5 to 6.0 by Expanded Disability Status Scale (EDSS) at baseline, with at least of 2 on the functional systems pyramidal function. 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. * Documented optic neuritis in the qualifying eye greater than 5 years before screening. * Steroid treatment for MS symptoms in the 30 days prior to consent * 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.
Where this trial is running
Atlanta, Georgia and 4 other locations
- Shepherd Center — Atlanta, Georgia, United States (Recruiting)
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States (Recruiting)
- Minnesota Center for Multiple Sclerosis — Plymouth, Minnesota, United States (Recruiting)
- UW Medicine Multiple Sclerosis Center-Northwest — Seattle, Washington, United States (Recruiting)
- West Virginia University — Morgantown, West Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Vice President of Clinical Affairs at SetPoint Medical
- Email: aderosier@setpointmedical.com
- Phone: 661-750-6140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.