The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Implant Procedure: The SetPoint System (study device)contains a miniaturized stimulator (implant) 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.
Disease-Modifying Therapies (DMTs): All subjects will continue treatment with standard of care disease-modifying therapies for the duration of the study.
Active stimulation: Active stimulation for 1 minute once per day
Non-active stimulation: Non-active stimulation for 1 minute once per day
Study summary
The MS pilot study will assess the safety and investigate the remyelinating effects of the SetPoint System (study device) in adult 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.
Eligibility
Primary outcome measure(s)
- Incidence of adverse events — Informed consent through Week 96
All adverse events from Screening through Week 96 (end of study) will be tabulated.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California Irvine Center for Clinical Research | Irvine | California | Recruiting |
| Shepherd Center | Atlanta | Georgia | Recruiting |
| Johns Hopkins School of Medicine | Baltimore | Maryland | Recruiting |
| Minnesota Center for Multiple Sclerosis | Plymouth | Minnesota | Recruiting |
| The University of Texas at Austin | Austin | Texas | Recruiting |
| The University of Texas Health Science Center at Houston | Houston | Texas | Recruiting |
| UW Medicine Multiple Sclerosis Center-Northwest | Seattle | Washington | Recruiting |
| West Virginia University | Morgantown | West Virginia | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | Recruiting |
More SetPoint Medical Corporation trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06796504 on ClinicalTrials.gov ↗ ← All trials in the USA