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 2026-04-20
60
Participants Needed
5
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The MS pilot study will assess the safety and investigate the remyelinating effects of the SetPoint System (study device) in adult patients with patients diagnosed with relapsing-remitting multiple sclerosis (RRMS). The SetPoint System is intended for adjunctive use with standard of care therapy for RRMS. The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll up to 60 participants at up to 10 sites. All eligible participants will undergo the implant procedure. Two-thirds of the participants will receive active stimulation (treatment) and the one-third will receive non-active stimulation (control). Following treatment evaluations at Week 48, there will be a one-way crossover of control subjects to active stimulation and a 48-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.
CONDITIONS
Official 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
- Diagnosed with relapsing-remitting multiple sclerosis (RRMS) by 2017 McDonald criteria
- Latency delay greater than 118 milliseconds on baseline visual evoked potential (VEP) in at least one eye
- Peri-papillary retinal nerve fiber layer (pRNFL) thickness over 70 microns in the qualifying eye
- Best corrected high-contrast vision better than 20/200 Snellen equivalent
- Best corrected low-contrast letter acuity no better than 40 letters in the qualifying eye
- No clinical relapse in the 12 months before consent
- No new or increased lesion volume on brain MRI within 1 year of consent
- Stable disease-modifying therapy (DMT) regimen before consent with specific duration based on DMT potency
- Expanded Disability Status Scale (EDSS) score between 2.5 and 6.0 with pyramidal function score at least 2
You will not qualify if you...
- Eye diseases or conditions interfering with visual testing (e.g., cataracts, macular degeneration, glaucoma, diabetic retinopathy)
- Severe myopia with refractive error of -6.00 diopters or more
- Other neurological disorders including moderate or severe cervical myelopathy
- Optic neuritis within 6 months prior to screening
- History of optic neuritis in qualifying eye over 5 years before screening
- Steroid treatment for MS symptoms within 30 days prior to consent
- Allergy to MRI contrast agents or inability to undergo MRI
- Regular use or dependence on nicotine products in the past year
- Not suitable candidate for surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 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
UW Medicine Multiple Sclerosis Center-Northwest
Seattle, Washington, United States, 98133
Actively Recruiting
5
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
V
Vice President of Clinical Affairs at SetPoint Medical
CONTACT
P
Paula Timm
CONTACT
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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