Actively Recruiting
The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study
Led by SetPoint Medical Corporation · Updated on 2026-05-20
60
Participants Needed
6
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and potential remyelinating effects of the SetPoint System, a miniaturized stimulator implanted on the vagus nerve, in adults diagnosed with relapsing-remitting multiple sclerosis (RRMS). This pilot study involves up to 60 participants and is designed as a randomized, double-blind, sham-controlled trial to assess this device's adjunctive use with standard disease-modifying therapies for RRMS. All participants will undergo surgery under general anesthesia to implant the device on the left side of the neck. The study includes two groups: about two-thirds will receive active daily stimulation for 1 minute, while one-third will receive non-active stimulation for the same duration. After 48 weeks of treatment and evaluation, control group participants will switch to active stimulation, followed by a 48-week open-label phase where all participants receive active treatment to monitor long-term safety. Participants will be involved in regular assessments up to Week 96, including safety monitoring through adverse event tracking. The study measures safety primarily by recording any adverse events from consent through Week 96. Participants will continue their standard disease-modifying therapies throughout the study, and researchers will evaluate responses to the stimulation device alongside ongoing clinical care.
CONDITIONS
Brief Title
The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22-50 years at informed consent.
- Diagnosis of relapsing-remitting multiple sclerosis by revised 2017 McDonald criteria.
- Latency delay greater than 118 milliseconds on baseline full-field transient pattern reversal visual evoked potential in at least one eye.
- Peri-papillary retinal nerve fiber layer greater than 70 microns on Optical Coherence Tomography in the qualifying eye.
- Best corrected high-contrast visual acuity better than 20/200 Snellen equivalent or letter score of 35.
- Best corrected low-contrast letter acuity no better than 40 letters in the qualifying eye.
- Absence of clinical relapse for at least 12 months prior to informed consent.
- No new or increased lesions on brain MRI within 1 year of consent.
- Stable regimen of disease-modifying therapy for at least 1 to 2 years prior to consent.
- Expanded Disability Status Scale score of 2.5 to 6.0 with at least 2 on pyramidal function at baseline.
You will not qualify if you...
- Ophthalmologic diseases or impairments that could interfere with visual testing (e.g., cataracts, macular degeneration, glaucoma).
- Severe myopia with refractive error of -6.00 diopters or more.
- Other neurological disorders including moderate or severe cervical myelopathy.
- Clinical optic neuritis within 6 months prior to screening.
- Optic neuritis in the qualifying eye more than 5 years before screening.
- Steroid treatment for MS symptoms within 30 days prior to consent.
- Allergy or inability to undergo MRI contrast imaging.
- Regular use or dependency on nicotine products within the past year.
- Not eligible for surgery under general anesthesia.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo surgery to have the SetPoint System device implanted on the vagus nerve under general anesthesia in an outpatient setting.
1 visit (in-person surgery day)
Duration - 48 weeks
Participants receive daily stimulation from the implanted device for 1 minute once per day for 48 weeks. Two-thirds of participants receive active stimulation, and one-third receive non-active stimulation (sham control). All continue standard disease-modifying therapies during this period.
Regular visits per study schedule (visit frequency not specified)
Duration - 48 weeks
After the initial 48-week treatment, control participants cross over to active stimulation. All participants receive active stimulation for an additional 48 weeks to evaluate long-term safety.
Regular visits per study schedule (visit frequency not specified)
Trial Site Locations
Total: 6 locations
1
Shepherd Center
Atlanta, Georgia, United States, 30309
Actively Recruiting
2
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
3
Minnesota Center for Multiple Sclerosis
Plymouth, Minnesota, United States, 55446
Actively Recruiting
4
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
5
UW Medicine Multiple Sclerosis Center-Northwest
Seattle, Washington, United States, 98133
Actively Recruiting
6
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
A
Amy Derosier
P
Paula Timm
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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