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

Launched by SETPOINT MEDICAL CORPORATION · Jan 22, 2025

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ClinConnect Summary

This clinical trial is testing a new device called the SetPoint System to see if it can help repair nerve damage in adults with a type of multiple sclerosis known as relapsing-remitting multiple sclerosis (RRMS). The device is a small stimulator that will be surgically placed under the skin on the neck. The study will involve up to 60 participants who meet specific criteria, such as being between 22 and 55 years old and having a confirmed diagnosis of RRMS. Participants will be divided into two groups: one will receive active stimulation from the device, while the other will receive a non-active version for comparison. After 24 weeks, those in the non-active group will switch to the active stimulation.

Participants can expect to undergo a minor surgical procedure and will be monitored for safety and effectiveness over the course of the study, which includes follow-ups lasting up to 72 weeks. It’s important to note that participants should not have had any recent relapses or significant changes in their treatment for at least one year, and they cannot have other eye or neurological conditions that could affect the study results. This study aims to explore a new approach to managing RRMS and could potentially lead to new treatment options in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 22-55 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 visual acuity (HCVA) better than LogMAR 1.0 by ETDRS (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 and/or no sign of MRI activity (1 or more gadolinium enhancing lesions or new T2 lesion developments) for at least 12 months prior to study enrollment while on a stable regimen of high potency disease-modifying therapy (DMT) prior to informed consent: if low-potency DMT, the DMT must have been started and maintained for at least two years prior to consent. If high-potency DMT, 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, etc.).
• • 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.
• • Change in DMT within 1 year (High-potency DMT) or 2 years (Low-potency DMT) before consent.
• • Glucocorticoid use within 30 days before 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.