The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study
1 other identifier
interventional
60
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2026
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2025
CompletedFirst Posted
Study publicly available on registry
January 28, 2025
CompletedStudy Start
First participant enrolled
March 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2030
April 20, 2026
March 1, 2026
1.8 years
January 22, 2025
April 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events
All adverse events from Screening through Week 96 (end of study) will be tabulated.
Informed consent through Week 96
Other Outcomes (8)
Reduction in VEP latency
Baseline (Screening) through Week 48
Change in lesion size as detected on MRI
Baseline (Screening) through Week 48
Change in number of letters accurately read
Baseline (Screening) through Week 48
- +5 more other outcomes
Study Arms (2)
Treatment
EXPERIMENTALActive stimulation for 1 minute once per day
Control
SHAM COMPARATORNon-active stimulation for 1 minute once per day
Interventions
All subjects will continue treatment with standard of care disease-modifying therapies for he duration of the study.
The SetPoint System (study device)contains a miniaturized stimulator (implnat) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings.
Eligibility Criteria
You may qualify if:
- Age 22-50 years at informed consent.
- Diagnosis of RRMS by revised 2017 McDonald 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Shepherd Center
Atlanta, Georgia, 30309, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287, United States
Minnesota Center for Multiple Sclerosis
Plymouth, Minnesota, 55446, United States
UW Medicine Multiple Sclerosis Center-Northwest
Seattle, Washington, 98133, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Vice President of Clinical Affairs at SetPoint Medical
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2025
First Posted
January 28, 2025
Study Start
March 31, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
September 30, 2030
Last Updated
April 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share