To evaluate the clinical efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) in treating post-stroke insomnia (PSI) and to elucidate its underlying central nervous system mechanisms.
Approach:
Study Design: A single-blind randomized controlled trial enrolling 48 patients with PSI, assigned to either a taVNS group or a sham-taVNS group.
Intervention: Both groups will receive their assigned intervention once daily, five days per week, for four weeks, alongside standard post-stroke treatment.
Outcomes: Primary outcomes include multimodal MRI indicators and secondary outcomes include clinical efficacy scales assessed at baseline, week 2, and week 4.
Data Analysis: Between- and within-group differences will be analyzed using t-tests and repeated-measures ANOVA, with correlation analyses relating neuroimaging changes to clinical improvement.
Key Findings:
PSI affects over 50% of stroke survivors and is linked to increased risk of stroke recurrence and secondary anxiety and depressive disorders.
Current treatments for PSI, such as sedative-hypnotics and cognitive behavioral therapy, have significant limitations, including risks of tolerance, dependence, and cognitive side effects.
taVNS has shown potential in treating primary insomnia and post-stroke depression, but evidence for its efficacy in PSI is limited to a few isolated case reports.
Interpretation:
The study aims to evaluate the clinical efficacy of taVNS for PSI and to elucidate its underlying central nervous system mechanisms.
Limitations:
Relatively small sample size.
Single-blind design may limit generalizability and introduce implementation bias.
Conclusion:
The findings will provide evidence-based support for the clinical application of taVNS in PSI.
