Xu Zheng Yan Ran, Fang Jia Jia, Fan Xiao Qin, Xu Long Long, Jin Gui Fang, Lei Mei Hua, Wang Yu Fei, Liu Jun Biao, Dong Fang, Jiang Lu Rong, Guo Yi
Department of Neurology, Epilepsy Center, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
Department of Neurology, The Fourth Affiliated Hospital, International Institutes of Medicine, Zhejiang University School of Medicine, Yiwu, China.
Epilepsy Behav. 2025 Feb;163:110226. doi: 10.1016/j.yebeh.2024.110226. Epub 2024 Dec 14.
OBJECTIVE: Our study aimed to evaluate the effectiveness and safety of transcutaneous auricular vagus nerve stimulation (taVNS) for treating mild to moderate depression in patients with epilepsy (PWE). METHODS: A single-arm, prospective, multi-center, pre-post controlled study was conducted in Eastern China. After a four-week baseline period, PWE with mild to moderate depression began treatment with taVNS, administered for 30 min, three times daily, over a 12-week period. The primary outcome measure was the change in 24-item Hamilton Depression Rating Scale (HAMD) scores from baseline to week 12. Secondary outcomes included the response and remission rates for depression at week 12, as well as changes in the 14-item Hamilton Anxiety Rating Scale (HAMA), the Pittsburgh Sleep Quality Index (PSQI), and the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) scores, and seizure frequency at weeks 4 and 12 compared to baseline. Adverse events (AEs) were recorded to assess the safety of taVNS. Both modified Intention-To-Treat (mITT) and Per-Protocol (PP) analyses were employed. RESULTS: Sixty-nine participants were enrolled in this study. Of these, 61 (88.4 %) completed the 4-week treatment phase, and 50 (72.5 %) finished the 12-week treatment phase. In the mITT analysis, HAMD scores significantly decreased by 4.54 ± 7.44 (p < 0.001) from baseline to week 12, with clinical response in 16 (26.2 %) and remission in 15 (24.6 %) patients. HAMA scores also decreased significantly by week 4 (3.23 ± 5.18, p < 0.001) and week 12 (4.95 ± 6.78, p < 0.001). PSQI scores and seizure frequency showed non-significant changes at week 4, but seizure frequency decreased significantly by week 12 (0.03 ± 10.47, p = 0.038). In the PP analysis, similar improvements were observed. After 12 weeks of taVNS compared to baseline, HAMD scores decreased significantly by 5.32 ± 8.98 (p < 0.001), with 32 % of patients achieving a clinical response and 24 % achieving clinical remission. And HAMA scores also decreased by 5.66 ± 7.54 (p < 0.001), seizure frequency by 0.14 ± 11.03 (p = 0.018), and PSQI scores by 1.06 ± 4.14 (p = 0.076).There was a significant increase in QOLIE-31 scores by 5.17 ± 14.71 (p = 0.020). Ten (14.5 %) patients experienced non-serious adverse events, the most common of which was ear pain (n = 4); one patient withdrew due to tinnitus enhancement; all resolved after reducing the stimulation intensity or stopping the treatment. CONCLUSION: Our study suggests that taVNS may effectively improve depressive symptoms in PWE. This may be an efficacious and safe treatment for mild to moderate depression in PWE.
目的：本研究旨在评估经皮耳迷走神经刺激（taVNS）治疗癫痫患者（PWE）轻至中度抑郁的有效性和安全性。 方法：在中国东部开展了一项单臂、前瞻性、多中心、前后对照研究。在为期四周的基线期后，患有轻至中度抑郁的PWE开始接受taVNS治疗，每天三次，每次30分钟，为期12周。主要结局指标是从基线到第12周24项汉密尔顿抑郁量表（HAMD）评分的变化。次要结局包括第12周时抑郁的缓解率和治愈率，以及14项汉密尔顿焦虑量表（HAMA）、匹兹堡睡眠质量指数（PSQI）、癫痫患者生活质量量表-31（QOLIE-31）评分的变化，以及与基线相比第4周和第12周的癫痫发作频率。记录不良事件（AE）以评估taVNS的安全性。采用改良意向性治疗（mITT）和符合方案（PP）分析。 结果：本研究共纳入69名参与者。其中，61名（88.4%）完成了4周治疗阶段，50名（72.5%）完成了12周治疗阶段。在mITT分析中，从基线到第12周，HAMD评分显著降低4.54±7.44（p<0.001），16名（26.2%）患者有临床反应，15名（24.6%）患者达到缓解。到第4周（3.23±5.18，p<0.001）和第12周（4.95±6.78，p<0.001）时，HAMA评分也显著降低。PSQI评分和癫痫发作频率在第4周时无显著变化，但到第12周时癫痫发作频率显著降低（0.03±10.47，p=0.038）。在PP分析中，观察到类似的改善。与基线相比，taVNS治疗12周后，HAMD评分显著降低5.32±8.98（p<0.001），32%的患者有临床反应，24%的患者达到临床缓解。HAMA评分也降低了5.66±7.54（p<0.001），癫痫发作频率降低了0.14±11.03（p=0.018），PSQI评分降低了1.06±4.14（p=0.076）。QOLIE-31评分显著增加5.17±14.71（p=0.020）。10名（14.5%）患者经历了非严重不良事件，最常见的是耳痛（n=4）；1名患者因耳鸣加重退出；所有症状在降低刺激强度或停止治疗后均得到缓解。 结论：我们的研究表明，taVNS可能有效改善PWE的抑郁症状。这可能是一种治疗PWE轻至中度抑郁的有效且安全的方法。
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