No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
22 – 60
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
SetPoint Medical Corporation · Industry
Who this trial is looking for
This trial is looking for adults with relapsing-remitting multiple sclerosis (RRMS) to test a new device. Participants will have a small device placed under their skin in a procedure to see if it helps with their condition.
Are You a Good Fit for This Trial?
Must be takingDisease-modifying therapy
You may be able to join if
I am between 22 and 60 years old.
I have been diagnosed with relapsing-remitting multiple sclerosis.
I have had MS for no more than 15 years.
I have certain vision test results that meet the trial's requirements.
I have not had a relapse in the past year.
I am currently on stable MS treatment.
I have a disability score of 2.5 to 6.5.
You may not be able to join if
I have other eye diseases that may affect my vision tests.
I have severe nearsightedness (myopia).
I have other serious neurological disorders.
I had optic neuritis in the last 6 months.
I received steroid treatment for MS symptoms in the last month.
My body mass index (BMI) is over 40.
I am allergic to MRI contrast agents or cannot have an MRI.
I am not a candidate for surgery.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 anest…
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.
Trial Locations
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Eligibility Criteria
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 reversa…
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.
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