JMIR Publications

ABSTRACT

Background:

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 identify the biomarkers and physiological signals related to lupus activity in order to understand how they change with different non-invasive vagus nerve stimulation frequency parameters. Finally, it is proposed to build a decision support system with integrated non-invasive wearable technologies for continuous cardiovascular and peripheral physiological sensing for adaptive, patient-specific optimisation of the non-invasive vagus nerve stimulation frequency parameters in real time.

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:

The protocol was designed to evaluate the efficacy and safety of trans auricular vagus nerve stimulation in patients with systemic lupus erythematosus. This multicentre, national, randomised, randomised, double-blind, parallel-group, placebo-controlled, randomised study will recruit a minimum of 18 patients diagnosed with this disease. Evaluation and treatment of patients will be conducted in an outpatient clinic and will include 12 visits. Visit 1 consists of a screening session. Subsequent visits up to visit 6 involve mixing treatment and evaluation sessions. Finally, the remaining visits correspond to early and late post-treatment follow-ups.

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 6 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; https://clinicaltrials.gov/study/NCT05704153.