Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 21, 2023
Date Accepted: Sep 8, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Optimising non-invasive vagus nerve stimulation for systemic lupus erythematosus: A multicentre, national, randomised, double-blind, parallel-group, placebo-controlled, outpatient clinical trial
ABSTRACT
Background:
Systemic lupus erythematosus is a chronic, multisystem, inflammatory disease of autoimmune aetiology, occurring predominantly in women. A major hurdle to the diagnosis, treatment, and therapeutic advancement of this disease is its heterogeneous nature, which presents a wide range of symptoms with varying severity, such as fatigue, fever, musculoskeletal involvement, neuropsychiatric disorders, and cardiovascular involvement. The current therapeutic approach to this disease includes the administration of immunomodulatory drugs that may produce unfavourable secondary effects.
Objective:
This study explores the known relationship between the autonomic nervous system and inflammatory pathways to improve patient outcomes by treating autonomic nervous system dysregulation in patients via non-invasive vagus nerve stimulation. In this study, data including biomarkers, physiological signals, patient outcomes, and patient quality of life is being collected and analysed. After the completion of the clinical trial, a computer model will be developed to optimise and personalise non-invasive vagus nerve stimulation in real time for the treatment of systemic lupus erythematosus.
Methods:
A multicentre, national, randomised, double-blind, parallel-group, placebo-controlled, outpatient study was designed to evaluate the efficacy and safety of trans auricular vagus nerve stimulation in patients with systemic lupus erythematosus.
Results:
On November 2022, data collection was initiated. Ten participants were scheduled for their initial appointment, of which, 8 have met the inclusion criteria and 7 have successfully completed the entire protocol. Patient enrolment and data collection is currently underway and is expected to be completed in December 2023.
Conclusions:
The results of this study will advance patient-tailored vagus nerve stimulation therapies, providing an adjunctive treatment solution for systemic lupus erythematosus that will fostering adoption of technology and, thus, widening the population with systemic lupus erythematosus can benefit from improvement of autonomic dysregulation, translating into a reduction of costs and better quality of life. Clinical Trial: ClinicalTrials.gov NCT05704153
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