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

We will study safety and efficacy of a vagus nerve stimulator to repair nerves damaged by MS.

Principal Investigator
Stage
Recruiting
Topics
Multiple Sclerosis, Neurosurgery, Pharma & Device
Funding Source
SetPoint Medical, Inc.
Study Number
1081

Study details

Researchers are evaluating the SetPoint System, which includes a stimulator that is surgically implanted on the left vagus nerve. The study will evaluate the safety of the device and its potential to help in remyelination of damaged nerves. Remyelination is the process of creating new myelin (fatty material that helps carry electrical impulses) around nerves damaged by MS. Participants in the study will remain on their current disease modifying therapy during the research.

Eligibility

To participate in this study, you must:

  • Be between 22 and 50 years of age
  • Have a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS)
  • Have had RRMS for 10 years or less
  • Have been on the same DMT for at least 12 months without a relapse

Who does not qualify

You cannot participate in this study if you:

  • Have an additional primary neurologic diagnosis
  • Have uncontrolled diabetes
  • Have a body mass index (BMI) > 35 kg/m2
  • Have a history of previous neck surgery
  • Are legally blind
  • Are pregnant or breastfeeding
  • Have a significant cardiovascular history