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

Exploring SetPoint System for MS treatment in a small study.

Recruiting
22-50 years
All
Phase N/A

This study is testing a device called the SetPoint System for people with relapsing-remitting multiple sclerosis (RRMS). RRMS is a condition where the immune system attacks the protective covering of nerves, causing symptoms like muscle weakness and vision problems. The SetPoint System is a small device that gets implanted in the neck and gives tiny electrical signals to a nerve called the vagus nerve. This study will see if this helps repair the nerve covering, called myelin.

Key Points:

  • Length and Visits: The study lasts about two years, with visits for surgery and follow-ups.
  • Treatment Groups: Two-thirds of participants get the real device, and one-third get a non-active device initially.
  • Risks: Surgery under general anesthesia is needed. There may be risks from the surgery and the device.

Participants must be between 22-50 years old and already on stable medication for RRMS. This study involves surgery and regular check-ups to monitor safety and effects. Participants should not have other eye problems or use nicotine products regularly.

Study details
    Relapsing Remitting Multiple Sclerosis

NCT06796504

SetPoint Medical Corporation

28 March 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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