ReVita: home-based transcutaneous auricular vagus nerve stimulation for reducing pathological fatigue in chronic neurological and post-infectious conditions-study protocol for a randomized, double-blind, sham-controlled trial
Abstract
Background: Pathological fatigue is one of the most prevalent and disabling symptoms across chronic neurological, post-infectious, and inflammatory diseases, yet effective treatments remain limited. Transcutaneous auricular vagus nerve stimulation (taVNS) is a safe, non-invasive neuromodulatory intervention that targets neuroimmune and autonomic pathways implicated in the development and persistence of fatigue. This randomized controlled trial investigates whether home-based taVNS can reduce fatigue severity in a transdiagnostic population.
Methods: This study is a randomized, double-blind, sham-controlled, parallel-group clinical trial conducted at the University Hospital Magdeburg. Eligible adult participants (≥ 18 years) with clinically significant chronic fatigue from two diagnostic clusters (neurological disorders and post-infectious syndromes) will be enrolled and randomized (1:1) to receive either active taVNS or sham stimulation for 4 weeks. Stimulation is self-administered at home twice daily for 30 min. The primary outcome is change in fatigue severity from baseline to the end of the intervention, assessed using the Modified Fatigue Impact Scale (MFIS). Secondary outcomes include quality of life (WHOQOL-BREF), depressive symptoms (BDI-II), daytime sleepiness (ESS), cognitive performance (SDMT and TAP subtest alertness), neurophysiological markers (resting-state EEG and P50 sensory gating) and HRV indices (Garmin Vivosmart 5). Blinding integrity will be assessed at…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
Read the paper
Related studies
- Calcium Ions in the Physiology and Pathology of the Central Nervous System
- AI-powered in silico twins: redefining precision medicine through simulation, personalization, and predictive healthcare
- In silico functional, structural and pathogenicity analysis of missense single nucleotide polymorphisms in human MCM6 gene
- In Silico drug repurposing pipeline using deep learning and structure based approaches in epilepsy
- Targeting serotonin receptors with phytochemicals – an in-silico study
- In silico exploration of anti-prostate cancer compounds from differential expressed genes
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.