The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study
Public ClinicalTrials.gov record NCT06796504. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06796504
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Interventions
- Implant Procedure Procedure
- Disease-Modifying Therapies (DMTs) Drug
- Active stimulation Device
- Non-active stimulation Device
Procedure · Drug · Device
Eligibility (public fields only)
- Age range
- 22 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 16, 2026
- Primary completion
- Dec 30, 2027
- Completion
- Sep 29, 2030
- Last update posted
- Sep 1, 2026
2026 – 2030
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California Irvine Center for Clinical Research | Irvine | California | 92617 | Recruiting |
| Shepherd Center | Atlanta | Georgia | 30309 | Recruiting |
| Johns Hopkins School of Medicine | Baltimore | Maryland | 21287 | Recruiting |
| Minnesota Center for Multiple Sclerosis | Plymouth | Minnesota | 55446 | Recruiting |
| The University of Texas at Austin | Austin | Texas | 78712 | Recruiting |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | Recruiting |
| UW Medicine Multiple Sclerosis Center-Northwest | Seattle | Washington | 98133 | Recruiting |
| West Virginia University | Morgantown | West Virginia | 26506 | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06796504, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 1, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06796504 live on ClinicalTrials.gov.