Implant Procedure: The SetPoint System (study device)contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings.
Disease-Modifying Therapies (DMTs): All subjects will continue treatment with standard of care disease-modifying therapies for the duration of the study.
Active stimulation: Active stimulation for 1 minute once per day
Non-active stimulation: Non-active stimulation for 1 minute once per day
Study summary
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.
Eligibility
Sex
ALL
Min age
22 Years
Max age
60 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of adverse events — Informed consent through Week 96 All adverse events from Screening through Week 96 (end of study) will be tabulated.
Trial sites (9)
Facility
City
Region
Status
University of California Irvine Center for Clinical Research
Irvine
California
Recruiting
Shepherd Center
Atlanta
Georgia
Recruiting
Johns Hopkins School of Medicine
Baltimore
Maryland
Recruiting
Minnesota Center for Multiple Sclerosis
Plymouth
Minnesota
Recruiting
The University of Texas at Austin
Austin
Texas
Recruiting
The University of Texas Health Science Center at Houston
Houston
Texas
Recruiting
UW Medicine Multiple Sclerosis Center-Northwest
Seattle
Washington
Recruiting
West Virginia University
Morgantown
West Virginia
Recruiting
Medical College of Wisconsin
Milwaukee
Wisconsin
Recruiting
More SetPoint Medical Corporation trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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