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The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study
Condition: Relapsing Remitting Multiple Sclerosis · Sponsor: SetPoint Medical Corporation
About this study
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.
This description comes directly from the study's public registry record.
Talk to the study team
Amy Derosier · aderosier@setpointmedical.com
Paula Timm · ptimm@setpointmedical.com
Always discuss trial participation with your own doctor first.
Locations (9)
| University of California Irvine Center for Clinical Research | Irvine, California, United States | Recruiting |
| Shepherd Center | Atlanta, Georgia, United States | Recruiting |
| Johns Hopkins School of Medicine | Baltimore, Maryland, United States | Recruiting |
| Minnesota Center for Multiple Sclerosis | Plymouth, Minnesota, United States | Recruiting |
| The University of Texas at Austin | Austin, Texas, United States | Recruiting |
| The University of Texas Health Science Center at Houston | Houston, Texas, United States | Recruiting |
| UW Medicine Multiple Sclerosis Center-Northwest | Seattle, Washington, United States | Recruiting |
| West Virginia University | Morgantown, West Virginia, United States | Recruiting |
| Medical College of Wisconsin | Milwaukee, Wisconsin, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06796504