RT Journal Article T1 Non-Invasive Transcutaneous Vagus Nerve Stimulation for the Treatment of Fibromyalgia Symptoms: A Study Protocol A1 Molero Chamizo, Andrés A1 Nitsche, Michael A. A1 Bolz, Armin A1 Andújar Barroso, Rafael Tomás A1 Alameda Bailén, José Ramón A1 García Palomeque, Jesús Carlos A1 Nathzidy Rivera-Urbina, Guadalupe AB Stimulation of the vagus nerve, a parasympathetic nerve that controls the neuro-digestive,vascular, and immune systems, induces pain relief, particularly in clinical conditions such as headacheand rheumatoid arthritis. Transmission through vagal afferents towards the nucleus of the solitarytract (NST), the central relay nucleus of the vagus nerve, has been proposed as the main physiologicalmechanism that reduces pain intensity after vagal stimulation. Chronic pain symptoms of fibromyalgia patients might benefit from stimulation of the vagus nerve via normalization of altered autonomicand immune systems causing their respective symptoms. However, multi-session non-invasive vagalstimulation effects on fibromyalgia have not been evaluated in randomized clinical trials. We proposea parallel group, sham-controlled, randomized study to modulate the sympathetic–vagal balance andpain intensity in fibromyalgia patients by application of non-invasive transcutaneous vagus nervestimulation (tVNS) over the vagal auricular and cervical branches. We will recruit 136 fibromyalgiapatients with chronic moderate to high pain intensity. The primary outcome measure will be painintensity, and secondary measures will be fatigue, health-related quality of life, sleep disorders, anddepression. Heart rate variability and pro-inflammatory cytokine levels will be obtained as secondaryphysiological measures. We hypothesize that multiple tVNS sessions (five per week, for 4 weeks) willreduce pain intensity and improve quality of life as a result of normalization of the vagal control ofnociception and immune–autonomic functions. Since both vagal branches project to the NST, we donot predict significantly different results between the two stimulation protocols PB MDPI SN 2076-3425 (electrónico) YR 2022 FD 2022 LK http://hdl.handle.net/10272/20754 UL http://hdl.handle.net/10272/20754 LA eng NO Molero-Chamizo, A., Nitsche, M. A., Bolz, A., Andújar Barroso, R. T., Alameda Bailén, J. R., García Palomeque, J. C., & Rivera-Urbina, G. N. (2022). Non-Invasive Transcutaneous Vagus Nerve Stimulation for the Treatment of Fibromyalgia Symptoms: A Study Protocol. In Brain Sciences (Vol. 12, Issue 1, p. 95). MDPI AG. https://doi.org/10.3390/brainsci12010095 DS Repositorio Institucional de la Universidad de Huelva RD 1 jun 2026