RecruitingNot ApplicableNCT06796504

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

Sponsor

SetPoint Medical Corporation

Enrollment

60 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

Relapsing Remitting Multiple Sclerosis

Summary

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.

Eligibility

Min Age: 22 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This pilot study tests whether a device called the SetPoint System — which uses mild electrical stimulation of a nerve in the neck (vagus nerve stimulation) — can help the nervous system rebuild the protective coating (myelin) around damaged nerve fibers in people with relapsing-remitting multiple sclerosis (RRMS). The study focuses on improving visual function as a measurable marker of nerve repair. **You may be eligible if...** - You are between 22 and 50 years old - You have been diagnosed with relapsing-remitting MS (RRMS) - You have a specific type of delayed visual signal (on a visual evoked potential test) in at least one eye, suggesting prior optic nerve damage - Your optic nerve still has enough remaining fibers (measured by an eye scan called OCT) - Your vision is reduced but not severely impaired in the affected eye **You may NOT be eligible if...** - You do not meet the specific visual measurement thresholds - You have a form of MS other than RRMS - You have another eye condition affecting vision independently of MS Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREProcedure/Surgery: Implant Procedure

The SetPoint System (study device)contains a miniaturized stimulator (implnat) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings.

DRUGDisease-Modifying Therapies (DMTs)

All subjects will continue treatment with standard of care disease-modifying therapies for he duration of the study.

DEVICEDevice: Active stimulation

Active stimulation for 1 minute once per day

DEVICEDevice: Non-active stimulation

Non-active stimulation for 1 minute once per day