Système SetPoint pour la remyélinisation dans la sclérose en plaques récurrente-rémittente

Date de début de l'étude : 31 décembre 2025

Inclusion Criteria: * Age 22-50 years at informed consent. * Diagnosis of RRMS by revised 2017 McDonald criteria. * Latency delay \>118 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. * 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. If intermediate-potency DMT, the DMT must have been started and maintained for at least two years prior to consent. If high-potency DMT, the DMT must have been started and maintained at least one year prior to consent. * Score of 2.5 to 6.0 by Expanded Disability Status Scale (EDSS) at baseline, with at least of 2 on the functional systems pyramidal function. 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. * Documented optic neuritis in the qualifying eye greater than 5 years before screening. * Steroid treatment for MS symptoms in the 30 days prior to consent * 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.