NCT06796504 - The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

March 30, 2027

Study Completion Date

September 30, 2030

Conditions

Relapsing Remitting Multiple Sclerosis

Interventions

PROCEDURE

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.

DRUG

Disease-Modifying Therapies (DMTs)

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

DEVICE

Device: Active stimulation

Active stimulation for 1 minute once per day

DEVICE

Device: Non-active stimulation

Non-active stimulation for 1 minute once per day

All Listed Sponsors

lead

SetPoint Medical Corporation

INDUSTRY