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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 48 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Stimulation will be delivered for 1 min once per day for 48 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the SetPoint System is safe and helps repair the protective coating around nerves in adults with relapsing-remitting multiple sclerosis (RRMS). A small device is placed on a nerve in the neck during surgery and used along with standard MS treatment. All participants get the device, but some receive no active stimulation for the first 48 weeks.

The MS pilot study will assess the safety and investigate the remyelinating effects of the SetPoint System (study device) in adult 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 22 to 60 years old and have RRMS diagnosed using the study’s required standards, no more than 15 years ago.
  • Have a vision nerve test showing slow signals: over 116 milliseconds in at least one eye, or a difference of over 6 milliseconds between eyes.
  • Have a scan showing that the nerve fiber layer at the back of the qualifying eye is thicker than 70 microns.
  • With glasses or contacts if needed, have clear-letter vision better than 20/200 or a letter score of 35.
  • In the qualifying eye, read no more than 40 faint letters on the required chart. Faint-letter vision must be worse than clear-letter vision.
  • Have had no MS flare-up for at least 12 months. The latest brain MRI, taken within the past year, must show no new or growing areas of damage.
  • Have been on a stable plan of medicine that changes the course of MS for at least one year.
  • Have a score of 2.5 to 6.5 on the EDSS, a scale that measures disability from MS.

Who can't join

  • Have an eye disease or other problem that could affect vision testing, or severe nearsightedness of -6.00 diopters or more.
  • Have another nervous system disorder, including known moderate or severe spinal cord problems in the neck.
  • Have had swelling of the nerve that carries vision signals within 6 months before screening.
  • Have used steroids for MS symptoms within 30 days before consent.
  • Have a body mass index (BMI), a measure based on height and weight, over 40.
  • Are allergic to MRI contrast dye or cannot have an MRI scan.
  • Have regularly used or depended on nicotine products within the past year.
  • Cannot safely have the surgery.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age 22-60 years at informed consent. * Diagnosis of RRMS by revised 2017 McDonald criteria. * MS disease duration does not exceed 15 years from date of diagnosis at the time of informed consent * Latency delay \>116 milliseconds on baseline full-field transient pattern reversal visual evoked potential (VEP) in at least one eye. Both eyes can be included if they meet all inclusion criteria.Patients who do not meet the absolute P100 latency threshold of 116 ms in either eye will qualify if they have an inter-eye difference in P100 latency of \>6 ms * Peri-papillary retinal nerve fiber layer (pRNFL) \> 70 microns on Optical Coherence Topography (OCT) in the VEP-qualifying eye (sufficient axons). * Best corrected high-contrast (HCVA) better than 20/200 Snellen equivalent or letter score of 35 * Best corrected low-contrast letter acuity (LCLA) by Sloan chart (2.5% black on white) of no better than 40 letters in the VEP-qualifying eye (Snellen equivalent of 20/40). (Best corrected LCLA must be worse than best corrected HCVA.) * Absence of clinical relapse for at least 12 months prior to informed consent * No new lesions or increase in existing lesion volume on most recent clinic brain MRI (must be within 1 year of consent) * Taking a stable regimen of disease-modifying therapy (DMT) prior to informed consent. The DMT must have been started and maintained at least one year prior to consent. * Score of 2.5 to 6.5 by Expanded Disability Status Scale (EDSS) at baseline. Exclusion Criteria: * Confounding ophthalmologic disease or impairments/conditions that could interfere with visual testing (e.g., cataracts, disc hemorrhage, macular star, cotton wool spots, macular degeneration, glaucoma, diabetic and/or hypertensive retinopathy, history of detached retina, etc.) * Severe myopia defined as a refractive error of -6.00 diopters or more * Concurrent neurological disorders, including known moderate or severe cervical myelopathy. * Clinical optic neuritis within 6 months before screening. * Steroid treatment for MS symptoms in the 30 days prior to consent * Body Mass Index \>40 kg/m2 * Hypersensitivity/allergy to MRI contrast agents and/or unable to perform MRI (e.g., claustrophobia). * Regular use of or dependency on nicotine products within the past year. * Not a surgical candidate.

Study sites (9)

CA

  • University of California Irvine Center for Clinical Research · Irvine, CA 92617Veronica Martin · Study contact · vero@hs.uci.eduMichael Sy, MD · Principal investigatorMore trials in Irvine

GA

MD

MN

TX

WA

WI

WV