Relapsing Remitting Multiple SclerosisNCT06796504
The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study
A study testing Implant Procedure, Disease-Modifying Therapies (DMTs) and Active stimulation in people with Relapsing Remitting Multiple Sclerosis, run by SetPoint Medical Corporation at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 60 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Implant Procedure, Disease-Modifying Therapies (DMTs) and Active stimulation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 9 sitesUnited States
- Study dates
- 17 Apr 2026to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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 and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Amy Derosier contact
Paula Timm contact
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Shepherd Center
Atlanta, Georgia, 30309
Michelle Tidwell, 404-367-1317, Michelle.Tidwell@shepherd.org
Cathy Furbish, 404-350-7591, Cathy.Furbish@shepherd.org
- Recruiting
The University of Texas at Austin
Austin, Texas, 78712
Melissa Ward, 512-324-7865, melissa.ward@austin.utexas.edu
Leorah Freeman, MD
- Recruiting
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
Adam Didouchevski, 443-818-1451, adidouc1@jh.edu
Bardia Nourbakhsh, MD
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Tanya Khan, 713-704-0823, Tanya.S.Khan@uth.tmc.edu
John Lincoln, MD
- Recruiting
University of California Irvine Center for Clinical Research
Irvine, California, 92617
Veronica Martin, vero@hs.uci.edu
Michael Sy, MD
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Alexis Micale, 414-955-0737, amicale@mcw.edu
Ahmed Obeidat, MD
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
Lauren Chase, 304-598-4000 ext. 179418, lauren.chase@wvumedicine.org
Melanie Ward, MD
- Recruiting
Minnesota Center for Multiple Sclerosis
Plymouth, Minnesota, 55446
Halie Kaufman, 763-243-8180, HKaufman@vivoinfusion.com
Richard Neiman, MD
- Recruiting
UW Medicine Multiple Sclerosis Center-Northwest
Seattle, Washington, 98133
Elisa McGee, 206-598-9260, emcgee@uw.edu
Yujie Wang, MD
About this study
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.
Read the detailed description
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.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Implant Procedure, Disease-Modifying Therapies (DMTs), Active stimulation, Non-active stimulation
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant ProcedureProcedure or surgery
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)Drug
All subjects will continue treatment with standard of care disease-modifying therapies for the duration of the study.
Active stimulationDevice
Active stimulation for 1 minute once per day
Non-active stimulationDevice
Non-active stimulation for 1 minute once per day
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Active stimulation for 1 minute once per day Receives: Procedure: Implant Procedure; Drug: Disease-Modifying Therapies (DMTs); Device: Active stimulation |
| Control | Sham comparator | Non-active stimulation for 1 minute once per day Receives: Procedure: Implant Procedure; Drug: Disease-Modifying Therapies (DMTs); Device: Non-active stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
All adverse events from Screening through Week 96 (end of study) will be tabulated.
Measured: Informed consent through Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start17 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SetPoint Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796504
- Sponsor's protocol ID
- SPM-040
- Status last verified
- Aug 2026
- First submitted
- 22 Jan 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT06796504
- Acronym / sponsor ID
- SPM-040
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SetPoint Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: Implant Procedure, Drug: Disease-Modifying Therapies (DMTs), Device: Active stimulationActive stimulation for 1 minute once per day |
| Control | Sham comparator | Procedure: Implant Procedure, Drug: Disease-Modifying Therapies (DMTs), Device: Non-active stimulationNon-active stimulation for 1 minute once per day |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant ProcedureThe 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. | Procedure or surgery | Control, Treatment |
| Disease-Modifying Therapies (DMTs)All subjects will continue treatment with standard of care disease-modifying therapies for the duration of the study. | Drug | Control, Treatment |
| Active stimulationActive stimulation for 1 minute once per day | Device | Treatment |
| Non-active stimulationNon-active stimulation for 1 minute once per day | Device | Control |
Primary outcome
Incidence of adverse events
Time frame: Informed consent through Week 96
All adverse events from Screening through Week 96 (end of study) will be tabulated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Derosier contact
Paula Timm contact
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant Procedure, Disease-Modifying Therapies (DMTs) and Active stimulation in people with Relapsing Remitting Multiple Sclerosis, run by SetPoint Medical Corporation at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Derosier (aderosier@setpointmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Informed consent through Week 96). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.