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

简要总结

主要结局

次要结局

• Questionnaire on SLE disease activity: Patient Global Assessment (PtGA)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit, weekly (week 3-7) until- and at follow-up (week 8).)
• Questionnaire on SLE disease activity: Systemic Lupus Activity Questionnaire (SLAQ)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit, and at follow-up (week 8).)
• Questionnaire on quality of life: Short form-12 (SF-12)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit, and at follow-up (week 8).)
• Questionnaire on autonomic symptoms: Composite Autonomic Symptoms Score 31 (COMPASS-31)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• Questionnaire on pain: Visual analog rating scale (VAS)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit, weekly (week 3-7) until- and at follow-up (week 8).)
• SLE disease activity: SLE Disease Activity Index 2000 (SLEDAI-2K)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• SLE disease activity: SLEDAI Responder Index 50% (SRI-50)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• SLE disease activity: SLE Disease Activity Score (SLE-DAS)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• SLE disease activity: Physician Global Assessment (PGA)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• SLE disease activity: Painful and swollen joints(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• Autonomic function: Resting heart rate variability (HRV)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• Autonomic function: Resting Cardiac Vagal Tone (CVT)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• Autonomic function: Cardiovascular autonomic reflex tests - heart rate response(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• Autonomic function: Cardiovascular autonomic reflex tests - blood pressure response(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• Autonomic function: Continuous heart rate and HRV monitoring(During period 1: From baseline to follow-up (day 7). During period 2: From baseline to day 7-visit.)
• Autonomic function: Sweat secretion(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• Cardiac function(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• Pain tolerability: Cold pressor test(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• Pain tolerability: Conditioned pain modulation (CMP)(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• Vascular function: Microvascular function(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• SLE routine status(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• SLE inflammatory status - Multiplex plasma cytokine analysis(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• SLE inflammatory status - Interferon-regulated gene expression(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• SLE inflammatory status - Functional immune cell stimulation(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• Kidney function(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• Metabolic control(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• SLE inflammatory status - Immune cell population distribution in whole blood(During period 1: At baseline and follow-up (day 7). During period 2: At baseline, at day 7-visit and at follow-up (week 8).)
• Medication usage(Medication status is reported at all visits (period 1: baseline and follow-up (day 7); period 2: baseline, day 7 and follow-up (week 8)) and three months after completing the study)