SetPoint implant to promote remyelination in relapsing-remitting MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized 2:1, double-blind, sham-controlled pilot enrolling up to 60 adults with relapsing-remitting MS at multiple U.S. centers. All participants receive a surgical implant on the left vagus nerve and continue their usual disease-modifying therapy; two-thirds get daily active stimulation and one-third get non-active (sham) stimulation for 48 weeks. Stimulation is delivered for 1 minute once per day, with blinded Week 48 evaluations followed by a one-way crossover of controls to active stimulation and a 48-week open-label safety follow-up. Eligibility targets adults 22–50 years old with specific visual pathway biomarkers (delayed VEP and preserved retinal nerve fiber layer) and stable MRI and clinical status prior to enrollment.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of California Irvine Center for Clinical Research
  Irvine, California, United States Recruiting
• Shepherd Center
  Atlanta, Georgia, United States Recruiting
• Johns Hopkins School of Medicine
  Baltimore, Maryland, United States Recruiting
• Minnesota Center for Multiple Sclerosis
  Plymouth, Minnesota, United States Recruiting
• The University of Texas at Austin
  Austin, Texas, United States Recruiting
• The University of Texas Health Science Center at Houston
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Amy Derosier
• Email: aderosier@setpointmedical.com

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.