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The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study

Exploring a new therapy for relapsing-remitting multiple sclerosis.

Recruiting
22-60 years
All
Phase N/A
**The SetPoint System Study for RRMS** This study is for people aged 22-60 with relapsing-remitting multiple sclerosis (RRMS). It will test the safety and effects of the SetPoint System, a small device placed in the neck to help nerve repair. The device sends tiny electrical signals to the vagus nerve, which is a major nerve in the body. Participants will have surgery to put the device in place and will be split into two groups—some will get active signals (treatment), while others won't (control). After 48 weeks, everyone will receive active signals for another 48 weeks to check long-term safety. **Key Points:** - The study lasts for 96 weeks with regular check-ups. - Participants must undergo surgery under general anesthesia. - Some risks exist, such as surgery-related complications. Eligible candidates should have had RRMS for less than 15 years and meet specific eye and vision criteria. They should not have had a recent RRMS relapse, use nicotine, or have certain eye or neurological conditions.
Study details
    Relapsing Remitting Multiple Sclerosis

NCT06796504

SetPoint Medical Corporation

17 October 2026

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