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The SetPoint System for Relapsing-Remitting Multiple Sclerosis

This study is testing the SetPoint System, a small device that is surgically placed on a nerve in your neck (vagus nerve), for people with relapsing-remitting multiple sclerosis (RRMS). The device delivers a small amount of electricity. The goal is to see if it's safe and if it can help with remyelination, which is the repair of the protective covering around nerve fibers. You would continue your current MS medications. The study plans to enroll up to 60 participants between 22 and 50 years old who have RRMS and a specific vision test result (latency delay >118 milliseconds on a visual evoked potential test). The main goal is to track any side effects. The current recruitment status is unclear.

Study design
This is a randomized, double-blind (meaning neither you nor your doctor will know if you're getting active or non-active stimulation), sham-controlled study involving up to 60 participants. Two-thirds of participants will receive active stimulation, and one-third will receive non-active stimulation.
What's involved
All participants will undergo a surgical procedure to implant the SetPoint System under general anesthesia. You will receive stimulation for 1 minute once per day for 48 weeks and continue your standard MS medications.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored from the time you give informed consent through Week 96. After 48 weeks, participants who received non-active stimulation will switch to active stimulation for another 48 weeks of follow-up.

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NCT06796504

The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study

Recruiting
NAAges 22–60InterventionalTreatment
SetPoint Medical Corporation
~60 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Procedure/Surgery: Implant ProcedureDisease-Modifying Therapies (DMTs)Device: Active stimulationDevice: Non-active stimulation

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Informed consent through Week 96

Conditions

Relapsing Remitting Multiple Sclerosis

Explore related trials

Multiple Sclerosis

Where it's being run

9 sites across 8 states
Texas2
California1
Georgia1
Maryland1
Minnesota1
Washington1
West Virginia1
Wisconsin1

Who to contact

Amy Derosier
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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.

What this trial measures

  • Incidence of adverse eventsInformed consent through Week 96

    All adverse events from Screening through Week 96 (end of study) will be tabulated.