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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2030-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS

NCT00813969

Relapsing-Remitting Multiple Sclerosis Secondary Progressive Multiple Sclerosis Progressive Relapsing Multiple Sclerosis

COMPLETED PHASE1

Epidural Stimulation in Multiple Sclerosis

NCT06019611

Multiple Sclerosis Demyelinating Disorder Autoimmune Diseases

COMPLETED NA

Wireless, Implantable Tibial Nerve Stimulator System for the Treatment of Refractory Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis

NCT04567264

Multiple Sclerosis, Relapsing-Remitting

COMPLETED NA

A Study to Evaluate the Safety of Administering Ocrelizumab Per a Shorter Infusion Protocol in Participants With Primary Progressive Multiple Sclerosis (PPMS) and Relapsing Multiple Sclerosis (RMS)

NCT03606460

Multiple Sclerosis

COMPLETED PHASE3

A Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis

NCT00087529

Multiple Sclerosis

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The MS pilot study is a 2:1 randomized, double-blind, sham-controlled, multi-center pivotal study enrolling up to 60 subjects at up to 10 study centers across the U.S. The 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 implanted inside the left side of the neck on the vagus nerve (implant procedure). The implant delivers a small amount of electricity (stimulation) to the nerve. All eligible subjects will undergo the surgery under general anesthesia. Two-thirds of the subjects will receive active stimulation (the treatment group) and the other one-third will receive non-active stimulation (the control group). Stimulation will be delivered for 1 min once per day for 48 weeks. 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. Blinding will be maintained for each individual participant until that participant has completed their Week 48 assessments.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Relapsing Remitting Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

Active stimulation for 1 minute once per day

Group Type EXPERIMENTAL

Procedure/Surgery: Implant Procedure

Intervention Type PROCEDURE

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.

Disease-Modifying Therapies (DMTs)

Intervention Type DRUG

All subjects will continue treatment with standard of care disease-modifying therapies for he duration of the study.

Device: Active stimulation

Intervention Type DEVICE

Active stimulation for 1 minute once per day

Control

Non-active stimulation for 1 minute once per day

Group Type SHAM_COMPARATOR

Procedure/Surgery: Implant Procedure

Intervention Type PROCEDURE

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.

Disease-Modifying Therapies (DMTs)

Intervention Type DRUG

All subjects will continue treatment with standard of care disease-modifying therapies for he duration of the study.

Device: Non-active stimulation

Intervention Type DEVICE

Non-active stimulation for 1 minute once per day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Procedure/Surgery: Implant Procedure

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.

Intervention Type PROCEDURE

Disease-Modifying Therapies (DMTs)

All subjects will continue treatment with standard of care disease-modifying therapies for he duration of the study.

Intervention Type DRUG

Device: Active stimulation

Active stimulation for 1 minute once per day

Intervention Type DEVICE

Device: Non-active stimulation

Non-active stimulation for 1 minute once per day

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 22-50 years at informed consent.
* Diagnosis of RRMS by revised 2017 McDonald 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.

Minimum Eligible Age

22 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No