SetPoint System for Remyelination in Relapsing-Remitting Multiple Sclerosis
Procedure/Surgery: Implant Procedure
+ Disease-Modifying Therapies (DMTs)
+ Device: Non-active stimulation
Autoimmune Diseases+5
+ Demyelinating Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: December 31, 2025
Actual date on which the first participant was enrolled.This study aims to explore a new treatment method for people with relapsing-remitting multiple sclerosis (RRMS), a condition where the immune system mistakenly attacks the protective covering of nerves. The focus is on a device called the SetPoint System, which might help repair this nerve damage. The study involves up to 60 adult participants in the United States who will continue their usual treatments for RRMS while trying this new approach. By understanding if the SetPoint System can safely and effectively promote nerve repair, this research could offer a new hope for better managing MS symptoms. Participants in the study will undergo surgery to implant a tiny device on the vagus nerve in the neck. This device will deliver mild electrical stimulation once a day for 24 weeks. Participants are split into two groups: one receiving active stimulation and the other receiving no stimulation. After 24 weeks, those in the non-active group will also start receiving active treatment in an open-label phase lasting 72 weeks. This design helps determine both immediate and long-term safety and effects. The study is conducted under strict controls to ensure accurate results and participant safety.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 22 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ShamGroup II
Experimental