Optimizing Noninvasive Vagus Nerve Stimulation for Systemic Lupus Erythematosus: Protocol for a Multicenter...

Area of Science:

• Immunology
• Neuroscience
• Medical Technology

Background:

• Systemic lupus erythematosus (SLE) is a chronic, multisystem autoimmune disease with heterogeneous symptoms and limited treatment options.
• Current therapies for SLE involve immunomodulatory drugs with potential adverse effects.
• Autonomic nervous system (ANS) dysregulation is implicated in SLE pathogenesis and inflammation.

Purpose of the Study:

• To explore the relationship between the ANS and inflammatory pathways in SLE.
• To evaluate the efficacy of noninvasive vagus nerve stimulation (nVNS) in treating ANS dysregulation in SLE patients.
• To develop a computer model for identifying SLE biomarkers and optimizing nVNS parameters.

Main Methods:

• A multicenter, randomized, double-blind, placebo-controlled study evaluating transauricular vagus nerve stimulation in SLE patients.
• Recruitment of at least 18 SLE patients for a 12-visit outpatient protocol.
• Collection and analysis of biomarkers, physiological signals, patient outcomes, and quality of life data.

Main Results:

• Data collection initiated in November 2022, with enrollment and data collection ongoing.
• Six out of 8 eligible participants have successfully completed the protocol.
• Full enrollment and data collection are anticipated by December 2023.

Conclusions:

• This study aims to advance personalized vagus nerve stimulation therapies for SLE.
• The findings are expected to support technology adoption for improved autonomic dysregulation management in SLE.
• Successful outcomes may lead to reduced healthcare costs and enhanced patient quality of life.