An interventional study of Implant Procedure and Disease-Modifying Therapies (DMTs) in Relapsing Remitting Multiple Sclerosis, sponsored by SetPoint Medical Corporation. Recruiting at 9 sites in United States. Open to participants aged 22 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by SetPoint Medical Corporation · Not applicable, Interventional, and Treatment
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.
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 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.
618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →SetPoint Medical Corporation is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active stimulation for 1 minute once per day
Procedure: Implant Procedure · Drug: Disease-Modifying Therapies (DMTs) · Device: Active stimulation
Non-active stimulation for 1 minute once per day
Procedure: Implant Procedure · Drug: Disease-Modifying Therapies (DMTs) · Device: Non-active stimulation
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.
All subjects will continue treatment with standard of care disease-modifying therapies for the duration of the study.
Active stimulation for 1 minute once per day
Non-active stimulation for 1 minute once per day
Incidence of adverse events
All adverse events from Screening through Week 96 (end of study) will be tabulated.
Time frame: Informed consent through Week 96
Reduction in VEP latency
Change from baseline full-field VEP P100 latency at Week 48.
Time frame: Baseline (Screening) through Week 48
Change in lesion size as detected on MRI
New T2 and/or contrast enhancing lesions Change in T2 lesion volume Change in phase (paramagnetic) rim lesions (PRL) Difference in the occurrence and volume of slowly expanding lesions
Time frame: Baseline (Screening) through Week 48
Change in number of letters accurately read
Change from baseline in LCLA and HCVA at Week 48.
Time frame: Baseline (Screening) through Week 48
Change in the NEI-VFQ-25 score
Change from baseline in NEI-VFQ-25 at Week 48
Time frame: Baseline (Screening) through Week 48
Change in EDSS scores
Change from baseline in EDSS at Week 48
Time frame: Baseline (Screening) through Week 48
Change in Modified MSFC scores
Change from baseline in modified MSFC at Week 48 for both composite score and each individual assessment (25-foot timed walk, 9-hole peg, and Symbol Digit Modalities Test)
Time frame: Baseline (Screening) through Week 48
Change in MFIS score
Change from baseline in MFIS at Week 48
Time frame: Baseline (Screening) through Week 48
Change in magnetization transfer ratios (MTR) in brain lesions
MTR is a surrogate to detect remyelination of lesions in the brain.
Time frame: Baseline (Screening) through Week 48
Plan to share: No
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Multiple Sclerosis, Relapsing-Remitting →
SetPoint Medical Corporation