The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study (NCT06796504)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California Irvine Center for Clinical Research — Irvine, California
Age range: 22 Years to 60 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- University of California Irvine Center for Clinical Research — Irvine, California
- Shepherd Center — Atlanta, Georgia
- Johns Hopkins School of Medicine — Baltimore, Maryland
- Minnesota Center for Multiple Sclerosis — Plymouth, Minnesota
- The University of Texas at Austin — Austin, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas
- UW Medicine Multiple Sclerosis Center-Northwest — Seattle, Washington
- West Virginia University — Morgantown, West Virginia
- Medical College of Wisconsin — Milwaukee, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Relapsing Remitting Multiple Sclerosis
- Functional Outcomes From Diets in Multiple Sclerosis — Birmingham, Alabama
Explore by condition: All Relapsing Remitting Multiple Sclerosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.