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

New vagus nerve stimulator tested for relapsing MS

NCT: NCT06796504 · Status: RECRUITING · Phase: N/A · Sponsor: SetPoint Medical Corporation · Started: 2026-03-31 · Est. Completion: 2030-09-30

Plain English Summary

The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study is a Not Applicable clinical trial sponsored by SetPoint Medical Corporation studying Relapsing Remitting Multiple Sclerosis. This study tests a new implantable device called the SetPoint System to see if it can help repair nerve damage in people with relapsing-remitting multiple sclerosis (RRMS). It is for adults aged 22-50 diagnosed with RRMS who have specific visual and nerve function test results. Participation involves a surgical procedure to implant a small device on the vagus nerve, followed by daily stimulation, either active or inactive, for a period. Current treatments for RRMS focus on managing the immune system to prevent new attacks; this study explores a new approach to potentially repair existing damage. The trial aims to enroll 60 participants.

Official Summary

The MS pilot study will assess the safety and investigate the remyelinating effects of the SetPoint System (study device) in adult patients with 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are between 22 and 50 years old and have been diagnosed with RRMS. You must have specific results on vision tests (VEP and OCT) and nerve function tests (EDSS). You cannot join if you have other eye conditions, severe nearsightedness, other neurological disorders, or have had optic neuritis recently. You must be stable on your current MS medication for a specified period and not have had a relapse or new MRI lesions in the past year. This trial is studying Relapsing Remitting Multiple Sclerosis, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures the safety of the device by tracking any side effects, ensuring the treatment is well-tolerated by patients. The specific primary outcome measures are: Incidence of adverse events (Informed consent through Week 96). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it investigates a novel approach to potentially repair nerve damage in MS, addressing a significant unmet need beyond current immune-suppressing therapies. This research targets Relapsing Remitting Multiple Sclerosis, where improved treatment options are needed.

Investor Insight

This pilot study by SetPoint Medical Corporation explores a new device for MS, a large market with significant unmet needs, suggesting potential for a novel therapeutic category if successful.

Is This Trial Right for Me?

Ask your doctor about the surgical risks, the daily stimulation process, and how this device might interact with your current MS medications. Participation involves surgery to implant the device, followed by daily use of the stimulator for a year, with regular check-ups and tests. You will be randomly assigned to receive either active stimulation or a placebo stimulation for the first year, after which all participants will receive active stimulation. This trial is currently recruiting participants. The trial is being conducted at 4 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Full Eligibility 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.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06796504?

NCT06796504 is a Not Applicable INTERVENTIONAL study titled "The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study." It is currently recruiting and is sponsored by SetPoint Medical Corporation. The trial targets enrollment of 60 participants.

What conditions does NCT06796504 study?

This trial investigates treatments for Relapsing Remitting Multiple Sclerosis. The primary condition under study is Relapsing Remitting Multiple Sclerosis.

What treatments are being tested in NCT06796504?

The interventions being studied include: Procedure/Surgery: Implant Procedure (PROCEDURE), Disease-Modifying Therapies (DMTs) (DRUG), Device: Active stimulation (DEVICE), Device: Non-active stimulation (DEVICE). The SetPoint System (study device)contains a miniaturized stimulator (implnat) 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.

What does Not Applicable mean for NCT06796504?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT06796504?

This trial is currently "Recruiting." It started on 2026-03-31. The estimated completion date is 2030-09-30.

Who is sponsoring NCT06796504?

NCT06796504 is sponsored by SetPoint Medical Corporation. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06796504?

The trial aims to enroll 60 participants. The trial is currently recruiting and accepting new participants.

How is NCT06796504 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT06796504?

The primary outcome measures are: Incidence of adverse events (Informed consent through Week 96). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06796504 being conducted?

This trial is being conducted at 4 sites, including Atlanta, Georgia; Plymouth, Minnesota; Seattle, Washington; Morgantown, West Virginia (United States).

Where can I find official information about NCT06796504?

The official record for NCT06796504 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06796504. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06796504 testing in simple terms?

This study tests a new implantable device called the SetPoint System to see if it can help repair nerve damage in people with relapsing-remitting multiple sclerosis (RRMS). It is for adults aged 22-50 diagnosed with RRMS who have specific visual and nerve function test results.

Why is this trial significant?

This trial matters because it investigates a novel approach to potentially repair nerve damage in MS, addressing a significant unmet need beyond current immune-suppressing therapies.

What are the potential risks of participating in NCT06796504?

The main risks involve the surgical procedure itself, including infection or bleeding. Potential side effects from the device or stimulation could include pain at the implant site, changes in heart rate or blood pressure, or nerve-related issues. As with any implanted device, there's a risk of device malfunction or the need for removal. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06796504?

Ask your doctor about the surgical risks, the daily stimulation process, and how this device might interact with your current MS medications. Participation involves surgery to implant the device, followed by daily use of the stimulator for a year, with regular check-ups and tests. You will be randomly assigned to receive either active stimulation or a placebo stimulation for the first year, after which all participants will receive active stimulation. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06796504 signal from an investment perspective?

This pilot study by SetPoint Medical Corporation explores a new device for MS, a large market with significant unmet needs, suggesting potential for a novel therapeutic category if successful. This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves a surgical procedure to implant a small device on the vagus nerve, followed by daily stimulation, either active or inactive, for a period. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.