SetPoint System for Multiple Sclerosis
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- SetPoint System
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Active stimulation for 1 minute once per day
Non-active stimulation for 1 minute once per day
Find a Clinic Near You
Who Is Running the Clinical Trial?
SetPoint Medical Corporation
Lead Sponsor
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