BACKGROUND External trigeminal nerve stimulation (ETNS) is an emergent, non-invasive neurostimulation therapy delivered bilaterally with adhesive skin electrodes. In previous studies, ETNS was associated to a decrease in seizure frequency in patients with focal drug-resistant epilepsy (DRE). OBJECTIVE To determine the long-term efficacy and tolerability of ETNS in patients with focal DRE. Moreover, to explore whether its efficacy depends on the epileptogenic zone (frontal or temporal), and its impact on mood, cognitive function, quality of life, and trigeminal nerve excitability. METHODS Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery, were randomized to ETNS or usual medical treatment. Participants were evaluated at 3, 6 and 12 months for efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability. RESULTS Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs. At 12 months, percentage of responders was 50% in ETNS group and 0% in control group. Seizure frequency in ETNS group decreased by -43.5% from baseline. Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively). Median stimulation intensity was 6.2 mA. ETNS improved quality of life, but not anxiety or depression. Long-term ETNS affected neither neuropsychological function, nor trigeminal nerve excitability. No relevant adverse events were observed. CONCLUSIONS ETNS is an effective and well-tolerated therapy for focal DRE. Patients with temporal epilepsy showed a better response than those with frontal epilepsy. Future studies with larger populations may define its role compared to other neurostimulation techniques. CLASSIFICATION OF EVIDENCE This study provides Class II evidence that ETNS reduces seizure frequency in patients with focal DRE.

中文翻译：

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三叉神经外刺激治疗耐药性癫痫：一项随机对照试验

背景外部三叉神经刺激(ETNS) 是一种紧急的、非侵入性的神经刺激疗法，通过粘性皮肤电极进行双侧递送。在之前的研究中，ETNS 与局灶性耐药性癫痫 (DRE) 患者的癫痫发作频率降低有关。目的 确定 ETNS 对局灶性 DRE 患者的长期疗效和耐受性。此外，探讨其疗效是否取决于致痫区（额叶或颞叶），及其对情绪、认知功能、生活质量和三叉神经兴奋性的影响。方法 40 名不适合手术的连续额叶或颞叶 DRE 患者随机接受 ETNS 或常规药物治疗。参与者在 3、6 和 12 个月时接受了疗效、副作用、情绪量表、神经心理学测试和三叉神经兴奋性。结果 受试者每月癫痫发作的中位数为 15 次，并尝试了 12.5 种抗癫痫药物的中位数。在 12 个月时，ETNS 组的应答者百分比为 50%，对照组为 0%。ETNS 组的癫痫发作频率比基线下降了 -43.5%。颞叶癫痫亚组的反应优于额叶癫痫亚组（分别为 55.56% 和 45.45%）。中位刺激强度为 6.2 mA。ETNS 改善了生活质量，但没有改善焦虑或抑郁。长期 ETNS 既不影响神经心理功能，也不影响三叉神经兴奋性。没有观察到相关的不良事件。结论 ETNS 是治疗局灶性 DRE 的一种有效且耐受良好的疗法。颞叶癫痫患者比额叶癫痫患者表现出更好的反应。与其他神经刺激技术相比，未来对更大人群的研究可能会定义其作用。证据分类 本研究提供了 ETNS 降低局灶性 DRE 患者癫痫发作频率的 II 类证据。