External trigeminal nerve stimulation for drug resistant epilepsy: A randomized controlled trial
External trigeminal nerve stimulation for drug resistant epilepsy: A randomized controlled trial
复制标题
DOI：
10.1016/j.brs.2020.06.005
复制
发表时间：
2020-09-01
影响因子：
7.7
通讯作者：
Carreno, Mar
中科院分区：
文献类型：
--
作者：
Gil-Lopez, Francisco;Boget, Teresa;Carreno, Mar
背景资料：外部三叉神经刺激（ETNS）是一种紧急的、非侵入性的神经刺激治疗，通过粘附性皮肤电极双侧输送。在先前的研究中，ETNS与局灶性耐药癫痫（DRE）患者的癫痫发作频率降低相关。目的：确定ETNS治疗局灶性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），以及其对情绪，认知功能，生活质量和三叉神经兴奋性的影响。方法：40例不适合手术治疗的额颞部DRE患者随机接受ETNS或常规药物治疗。在3个月、6个月和12个月时对参与者进行疗效、副作用、情绪量表、神经心理学测试和三叉神经兴奋性评估。结果：受试者每月平均癫痫发作15次，平均使用12.5种抗癫痫药物。12个月时，ETNS组的应答者百分比为50%，对照组为0%。ETNS组的癫痫发作频率较基线降低了-43.5%。颞叶癫痫亚组有效率优于额叶癫痫亚组（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。结论：ETNS是治疗局灶性DRE的一种有效且耐受性良好的治疗方法。颞叶癫痫患者比额叶癫痫患者表现出更好的反应。未来的研究与更大的人口可能会定义其作用相比，其他neurostimulationtechniques.Classification的证据：这项研究提供了II类证据，ETNS减少癫痫发作的频率与局灶性DRE患者。(C)2020作者（S）爱思唯尔公司出版。
Background: External trigeminal nerve stimulation (ETNS) is an emergent, non-invasive neuro-stimulation 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. (C) 2020 The Author(s). Published by Elsevier Inc.