Study rationale and clinical trial design.
A. Immunomodulation neural pathways associated with vagus nerve stimulation include cholinergic anti-inflammatory pathway, sympathetic nervous system, and hypothalamic-pituitary-adrenal (HPA) axis. Immunogenic stimuli activate vagal afferents terminating primarily in the dorsal vagal complex. Ascending projections from the dorsal vagal complex reach the paraventricular nucleus (PVN) and rostral ventromedial medulla (RVM), activating the hypothalamic-pituitary-adrenal (HPA) axis and sympathetic system, respectively, to regulate the immune response. taVNS can affect cardiovascular function through the sympathetic system or efferent vagus nerve. B-C. Clinical trial structure and treatment protocol. Patients in the taVNS group received electrical stimulation (0.4 mA, 250 µs pulse width, 20 Hz) for 20 minutes twice daily. Sham group patients wore the ear clip on the earlobe for the same duration. D. Ear clip application for taVNS treatment.