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

Rigshospitalet, Denmark1 site in 1 country75 target enrollmentAugust 24, 2022

ConditionsSystemic Lupus Erythematosus Autonomic Dysfunction Autonomic Neuropathy Fatigue

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Systemic Lupus Erythematosus
Sponsor: Rigshospitalet, Denmark
Enrollment: 75
Locations: 1
Primary Endpoint: Fatigue (changes during period 1 and 2)
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 24, 2022

End Date

August 23, 2023

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rigshospitalet, Denmark

Responsible Party

Principal Investigator

Søren Jacobsen

Professor, MD, DMSc

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Fatigue (changes during period 1 and 2)

Time Frame: During period 1: At baseline, daily (day 2-6) until- and at follow-up (day 7). During period 2: At baseline, at day 7-visit, weekly (week 3-7) until- and at follow-up (week 8).

The FACIT-Fatigue Scale is a short, 13-item, tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point scale for each item. The theoretical maximum value is 52 (maximal fatigue) and minimum 0 (no fatigue).

Secondary Outcomes

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)