Effects of transcutaneous auricular vagus nerve stimulation on functional brain activity in patients with prolonged disorders of consciousness: a randomized controlled trial protocol using functional near-infrared spectroscopy and electroencephalography
Randomized trial evaluates brain function changes in prolonged disorders of consciousness using vagus nerve stimulation, suggesting potential therapeutic pathways.
Key Points
This study aims to investigate how transcutaneous auricular vagus nerve stimulation affects brain function and autonomic activity in patients with prolonged disorders of consciousness.
Randomized controlled trial with 60 patients allocated to taVNS, sham, or control groups (20 per group) for 4 weeks.
Primary outcome: changes in Coma Recovery Scale-Revised scores over treatment weeks 1, 2, and 4.
Secondary outcomes include functional brain activity assessed by EEG and fNIRS, and autonomic modulation indexed by heart rate variability.
Expected to characterize taVNS effects on brain networks and consciousness recovery in pDOC.
Findings will elucidate neurobiological mechanisms of taVNS, potentially guiding clinical application.
Assessment includes continuous monitoring and documentation of adverse events throughout the trial.