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

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.

Description

Eligibility

Age range

22–50 years

Sex

All

Healthy volunteers

No

Interventions

• Procedure
  Procedure/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.

• Drug
  Disease-Modifying Therapies (DMTs)

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

• Device
  Device: Active stimulation

  Active stimulation for 1 minute once per day

• Device
  Device: Non-active stimulation

  Non-active stimulation for 1 minute once per day

Locations (5)