Recruiting

SetPoint System

Sponsor:

SetPoint Medical Corporation

Code:

NCT06796504

Conditions

Relapsing Remitting Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 22 - 60

Healthy Volunteers: Not accepted

Interventions

Implant Procedure

Disease-Modifying Therapies (DMTs)

Active stimulation

Non-active stimulation

Study Details

Brief 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.

Conditions

Relapsing Remitting Multiple Sclerosis

Study ID

NCT06796504

Start date

Apr 17, 2026

Status verified date

Aug, 2026

Completion date

Sep 30, 2030

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Active stimulation for 1 minute once per day

sham comparator: Control

Non-active stimulation for 1 minute once per day

Interventions

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

Primary outcome measure

  • Incidence of adverse events [ Time Frame: Informed consent through Week 96 ]

Central Contacts and Locations

Central contacts

Amy Derosier

aderosier@setpointmedical.com

Paula Timm

ptimm@setpointmedical.com

Locations

University of California Irvine Center for Clinical Research

Recruiting

Irvine, California, United States, 92617

Contacts

Veronica Martin

vero@hs.uci.edu

Principal Investigator:

Michael Sy, MD

Shepherd Center

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Michelle Tidwell

404-367-1317Michelle.Tidwell@shepherd.org

Cathy Furbish

404-350-7591Cathy.Furbish@shepherd.org

Principal Investigator:

Jacqueline Rosenthal, MD

Johns Hopkins School of Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Adam Didouchevski

443-818-1451adidouc1@jh.edu

Principal Investigator:

Bardia Nourbakhsh, MD

Minnesota Center for Multiple Sclerosis

Recruiting

Plymouth, Minnesota, United States, 55446

Contacts

Halie Kaufman

763-243-8180HKaufman@vivoinfusion.com

Principal Investigator:

Richard Neiman, MD

The University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

Contacts

Melissa Ward

512-324-7865melissa.ward@austin.utexas.edu

Principal Investigator:

Leorah Freeman, MD

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Tanya Khan

713-704-0823Tanya.S.Khan@uth.tmc.edu

Principal Investigator:

John Lincoln, MD

UW Medicine Multiple Sclerosis Center-Northwest

Recruiting

Seattle, Washington, United States, 98133

Contacts

Elisa McGee

206-598-9260emcgee@uw.edu

Principal Investigator:

Yujie Wang, MD

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Lauren Chase

304-598-4000lauren.chase@wvumedicine.org

Principal Investigator:

Melanie Ward, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Alexis Micale

414-955-0737amicale@mcw.edu

Principal Investigator:

Ahmed Obeidat, MD

More Information

Sponsor

SetPoint Medical Corporation

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by SetPoint Medical Corporation on 2026-09-02.