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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
SetPoint Medical Corporation
Study ID
NCT06796504
Status
Recruiting
Apply to this trial

Conditions

  • Relapsing Remitting Multiple Sclerosis

Eligibility Criteria

Sex
ALL
Age
22 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Procedure/Surgery: Implant Procedure — 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) — DRUG
    All subjects will continue treatment with standard of care disease-modifying therapies for he duration of the study.
  • Device: Active stimulation — DEVICE
    Active stimulation for 1 minute once per day
  • Device: Non-active stimulation — DEVICE
    Non-active stimulation for 1 minute once per day

Study Details

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.

Key Dates

Start date
Apr 17, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Sep 30, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Active stimulation for 1 minute once per day
  • Sham Comparator: Control
    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

Locations (6)

FacilityCityStateZIPSite coordinators
Shepherd CenterAtlantaGeorgia30309
Michelle Tidwell
[email protected]
404-367-1317
Cathy Furbish
[email protected]
404-350-7591
Jacqueline Rosenthal, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins School of MedicineBaltimoreMaryland21287
Adam Didouchevski
[email protected]
443-818-1451
Bardia Nourbakhsh, MD (PRINCIPAL_INVESTIGATOR)
Minnesota Center for Multiple SclerosisPlymouthMinnesota55446
Halie Kaufman
[email protected]
763-243-8180
Jonathan Calkwood, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas Health Science Center at HoustonHoustonTexas77030
Tanya Khan
[email protected]
713-704-0823
John Lincoln, MD (PRINCIPAL_INVESTIGATOR)
UW Medicine Multiple Sclerosis Center-NorthwestSeattleWashington98133
Elisa McGee
[email protected]
206-598-9260
Yujie Wang, MD (PRINCIPAL_INVESTIGATOR)
West Virginia UniversityMorgantownWest Virginia26506
Lauren Chase
[email protected]
304-598-4000
Melanie Ward, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Shepherd Center· Atlanta, GAJohns Hopkins School of Medicine· Baltimore, MDMinnesota Center for Multiple Sclerosis· Plymouth, MNThe University of Texas Health Science Center at Houston· Houston, TXUW Medicine Multiple Sclerosis Center-Northwest· Seattle, WAWest Virginia University· Morgantown, WV

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