Efficacy and safety of transcutaneous auricular vagus nerve stimulation in drug-resistant epilepsy: a single-center prospective real-world study.

Background: Drug-resistant epilepsy (DRE) imposes a heavy disease burden and urgently requires new, effective, and safe treatment options. Objective: To evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (ta-VNS) in patients with DRE. Design: Ongoing, single-center, prospective real-world study. Data sources and methods: Patients diagnosed with DRE and undergoing ta-VNS treatment at Beijing Tiantan Hospital, affiliated with Capital Medical University, were prospectively enrolled in this study between January 2023 and December 2024. The follow-up period lasted 1-2 years. The frequency of seizure reduction was assessed using seizure diaries, with a 50% decrease in seizure frequency deemed indicative of efficacy. Adverse reactions and comorbidities were recorded concurrently. All patients were maintained on stable anti-seizure medications during this study. Results: Ninety-nine patients were enrolled, among whom 16 were lost to follow-up and 18 refused follow-up. Ultimately, 65 patients were successfully followed up for analysis. The overall efficacy rate was 61.54%. Specifically, 15 patients experienced seizure reductions >90%, 8 achieved a reduction between 75% and 90%, 17 demonstrated a reduction ranging from 50% to 75%, and 1 exhibited a reduction of <50%. There were no severe adverse events, although 10 patients reported mild side effects (e.g., ear tingling and tinnitus). The efficacy rate was found to be independent of variables such as age, sex, treatment frequency, and type of epilepsy. However, it demonstrated an association with baseline seizure frequency prior to treatment and the etiology of epilepsy. Patients exhibiting a higher baseline frequency of seizures (>30 episodes per month) demonstrated significantly improved response rates, with an efficacy rate of 90.9%. Etiologies, including posttumor surgery, congenital brain dysplasia, and genetic mutations, demonstrated efficacy rates >90%. Conclusion: The efficacy of ta-VNS was 61.54% in patients with DRE. Patients with high baseline seizure frequency or identifiable etiologies tended to experience greater therapeutic benefits. Owing to its noninvasive nature and favorable safety profile, it presents a promising alternative for the management of DRE.