The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study
NCT06796504
This study is recruiting at 9 US sites in 8 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Relapsing Remitting Multiple Sclerosis
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Not applicable
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- SetPoint Medical Corporation
- Last updated on ClinicalTrials.gov
- September 2, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 1
- University of California Irvine Center for Clinical Research · Irvine, CA
Georgia · 1
- Shepherd Center · Atlanta, GA
Maryland · 1
- Johns Hopkins School of Medicine · Baltimore, MD
Minnesota · 1
- Minnesota Center for Multiple Sclerosis · Plymouth, MN
Texas · 2
- The University of Texas at Austin · Austin, TX
- The University of Texas Health Science Center at Houston · Houston, TX
Washington · 1
- UW Medicine Multiple Sclerosis Center-Northwest · Seattle, WA
West Virginia · 1
- West Virginia University · Morgantown, WV
Wisconsin · 1
- Medical College of Wisconsin · Milwaukee, WI
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.