Vagus Nerve Stimulation for Systemic Lupus Erythematous

NACompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

August 24, 2022

Primary Completion Date

August 23, 2023

Study Completion Date

August 23, 2023

Conditions
Systemic Lupus ErythematosusAutonomic DysfunctionAutonomic NeuropathyFatigue
Interventions
DEVICE

Non-invasive transcutaneous vagus nerve stimulation (tVNS)

tVNS delivers an electrical current to the cervical branch of the vagus nerve. Four minutes of bilateral stimulation 4 times per day for 7 days (period 1) and 2 times per day for 8 weeks (period 2) are performed. The two periods are separated by a 2 weeks wash-out period.

DEVICE

Sham vagus nerve stimulation

"The sham device produces a slight vibrating sound, but does not produce an electical current and hence, does not activate the vagus nerve.~Four minutes of bilateral stimulation 4 times per day for 7 days (period 1) and 2 times per day for 8 weeks (period 2). The two periods are separated by a 2 weeks wash-out period."

Trial Locations (1)

2100

Rigshospitalet, Copenhagen

All Listed Sponsors
collaborator

Aalborg University Hospital

OTHER

lead

Rigshospitalet, Denmark

OTHER