Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS) for Treatment of Drug-Resistant Epilepsy: A Randomized, Double-Blind Clinical Trial.

This study explored the efficacy and safety of transcutaneous auricular vagus nerve stimulation (ta-VNS) in patients with epilepsy. A total of 150 patients were randomly divided into active stimulation group and control group. At baseline and 4, 12, and 20 weeks of stimulation, demographic information, seizure frequency, and adverse events were recorded; at 20 weeks, the patients underwent assessment of quality of life, Hamilton Anxiety and Depression scale, MINI suicide scale, and MoCA scale. Seizure frequency was determined according to the patient's seizure diary. Seizure frequency reduction > 50% was considered effective. During our study, the antiepileptic drugs were maintained at a constant level in all subjects. At 20 weeks, the responder rate was significantly higher in active group than in control group. The relative reduction of seizure frequency in the active group was significantly higher than that in the control group at 20 weeks. Additionally, no significant differences were shown in QOL, HAMA, HAMD, MINI, and MoCA score at 20 weeks. The main adverse events were pain, sleep disturbance, flu-like symptoms, and local skin discomfort. No severe adverse events were reported in active and control group. There were no significant differences in adverse events and severe adverse events between the two groups. The present study showed that ta-VNS is an effective and safe therapy for epilepsy. Furthermore, the benefit in QOL, mood, and cognitive state of ta-VNS needs further validation in the future study although no significant improvement was shown in this study.