Transcutaneous Vagus Nerve Stimulation in SLE

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

May 15, 2025

Primary Completion Date

November 30, 2026

Study Completion Date

May 31, 2027

Conditions
Systemic Lupus Erythematosus
Interventions
DEVICE

Active vagus nerve stimulation

Patients will receive transcutaneous stimulation of the vagus nerve for 5 minutes daily for 28 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes will be placed on the skin for stimulation. The electrical pulse generator is turned on and the amplitude of stimulation increased to the greatest amount tolerated. Patients will be followed through day 57 to assess durability of the intervention.

DEVICE

Sham vagus nerve stimulation

Patients will receive transcutaneous stimulation of the vagus nerve for 5 minutes daily for 28 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes will be placed on the skin for stimulation. The electrical pulse generator is turned on and the amplitude of stimulation increased to the greatest amount tolerated, however, the vagus nerve will not be stimulated. Patients will be followed through day 57 to assess durability of the intervention.

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Lupus Research Alliance

OTHER

lead

Northwell Health

OTHER

NCT06987565 - Transcutaneous Vagus Nerve Stimulation in SLE | Biotech Hunter | Biotech Hunter