NCT05315739

Vagus Nerve Stimulation for Systemic Lupus Erythematous

Vagus Nerve Stimulation as a Novel Treatment for Systemic Lupus Erythematous: A Double Blinded Randomized Controlled Trail

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial uses a double blinded, randomized 1:1 (active:sham) placebo controlled, parallel group design, investigating the effects of transcutaneous vagus nerve stimulation (tVNS) in patients with systemic lupus erythematosus (SLE). The main objective is to evaluate whether adjuvant treatment with tVNS in SLE patients with signs of autonomic dysfunction and fatigue improves patient perceived levels of fatigue. Secondary outcomes include tVNS induced changes to: patient reported outcomes, autonomic nervous system function, SLE disease activity, immunologic profile, tolerability of pain and organ (cardiac, vascular and kidney) functions. Participants are randomized to received either active non-invasive transcutaneous vagus nerve stimulation (tVNS) or inactive sham stimulation. The study period is divided in two periods. The first period investigates the effects of short-term, high-intensity tVNS treatment. The second phase investigates the effects of long-term, middle-intensity tVNS treatment.

Conditions

• Systemic Lupus Erythematosus
• Autonomic Dysfunction
• Autonomic Neuropathy
• Fatigue

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-24
• Primary completion: 2023-08-23
• Completion: 2023-08-23
• First posted: 2022-04-07
• Last updated: 2025-09-26

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated device study