Pilot Study Evaluating the SetPoint Vagus Nerve Stimulator Implant for Myelin Repair in Adults with Relapsing-Remitting Multiple Sclerosis

What this Trial Is About

Researchers are evaluating the safety and remyelinating effects of the SetPoint System, a miniaturized nerve stimulator implanted in the neck, in adults with relapsing-remitting multiple sclerosis RRMS. This pilot study involves up to 60 participants who continue their standard disease-modifying therapies while using the device. The study aims to understand how this device, used alongside standard care, might support myelin repair in RRMS patients. Participants will undergo surgery to implant the device on the left vagus nerve under general anesthesia. They will be randomly assigned so that two-thirds receive active stimulation and one-third receive non-active sham stimulation daily for one minute over 48 weeks. After the first 48 weeks, control group participants will crossover to active stimulation, and all participants will be followed openly for an additional 48 weeks to observe long-term safety. During the study, participants will be monitored for adverse events from consent through 96 weeks. They will have regular assessments during the treatment and follow-up periods to evaluate safety and device effects. The study includes evaluations such as visual evoked potentials, retinal imaging, and neurological disability scoring to track disease status and response to the intervention.

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