Clinical trial for Relapsing Remitting Multiple Sclerosis
Official title The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study
ClinicalTrials.gov ID: NCT06796504
What this study is testing
What is SetPoint System?
An investigational implantable device being studied as a potential adjunctive treatment for relapsing‑remitting multiple sclerosis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether the SetPoint System can safely help the brain repair nerve damage in people with relapsing‑remitting multiple sclerosis.
- Who it's for
- You may be able to join if you are an adult with relapsing‑remitting multiple sclerosis and can travel to one of the study sites.
- What's involved
- You will have a tiny device implanted under your skin near the vagus nerve. After the surgery you will receive either real or pretend electrical stimulation. If you get the pretend version, you will later switch to real stimulation. You will have check‑ins and tests during the study.
- Time commitment
- The study lasts about 48 weeks, with visits for surgery, regular check‑ins, and a final follow‑up after the last stimulation.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 60
You may be able to join if
- 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.
- Peri-papillary retinal nerve fiber layer (pRNFL) \> 70 microns on Optical Coherence Topography (OCT) in the VEP-qualifying eye (sufficient axons).
You likely can't join if
- Confounding ophthalmologic disease or impairments/conditions that could interfere with visual testing (e.g., cataracts, disc hemorrhage, macular...
- 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
See the full eligibility 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.
- 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).
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Irvine, California, United States
- Atlanta, Georgia, United States
- Baltimore, Maryland, United States
- Plymouth, Minnesota, United States
- Austin, Texas, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Morgantown, West Virginia, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Irvine, California, United States; Atlanta, Georgia, United States; Baltimore, Maryland, United States; Plymouth, Minnesota, United States; Austin, Texas, United States; Houston, Texas, United States and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.