Plymouth, MNNCT06796504Now EnrollingIRB Ready

Relapsing Remitting Multiple Sclerosis Clinical Trial in Plymouth, MN

Access cutting-edge relapsing remitting multiple sclerosis treatment through this clinical trial at a research site in Plymouth. Study-provided care at no cost to qualified participants.

Sponsored by SetPoint Medical Corporation

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Expert Care in Plymouth

Access relapsing remitting multiple sclerosis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related relapsing remitting multiple sclerosis treatment provided free

Apply for This Plymouth Location

Check if you qualify for this relapsing remitting multiple sclerosis clinical trial in Plymouth, MN

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Why Participate?

  • No-Cost Study Care

  • Local to Plymouth

    Convenient for MN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Plymouth site if eligible
  4. 4Begin participation

About This Relapsing Remitting Multiple Sclerosis Study in Plymouth

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.

Sponsor: SetPoint Medical Corporation

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Plymouth?

Yes, this clinical trial (NCT06796504) has an active research site in Plymouth, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Relapsing Remitting Multiple Sclerosis Treatment Options in Plymouth, MN

If you're searching for relapsing remitting multiple sclerosis treatment options in Plymouth, MN, this clinical trial (NCT06796504) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Plymouth research site is actively enrolling participants for this clinical trial. You'll receive care from experienced relapsing remitting multiple sclerosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all relapsing remitting multiple sclerosis clinical trials near you to find additional studies recruiting in your area.

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