TY - T1的随机对照试验的三叉神经刺激耐药性癫痫JF -神经学乔-神经病学SP - 786 LP - 791 - 10.1212 / WNL。首页0 b013e318285c11a六世- 80 - 9 AU -克里斯托弗·m·DeGiorgio盟盟杰森·索斯-伊恩·a·库克AU -丹妮拉·马尔科维奇盟Jeffrey Gornbein盟戴安娜穆雷AU -桑德拉·奥维耶多盟史蒂文·戈登AU -瓜达卢佩Corralle-Leyva AU -科林·p·Kealey厚颜盟克里斯蒂n见鬼Y1 - 2013/02/26 UR - //www.ez-admanager.com/content/80/9/786.abstract N2 -目的:探索外部刺激三叉神经的安全性和有效性(eTNS)耐药性癫痫患者(DRE)使用一个双盲随机对照试验设计和试验首页的治疗和控制参数的适用性为三期多中心临床试验做准备。方法:这是一个双盲随机主动控制试验DRE。五十每月科目和2个或更多的部分性发作(复杂的部分或tonic-clonic)为期6个月的进入了一个基线时期中,然后评估在6、12日和18周期间急性治疗期。受试者被随机分配到治疗(eTNS 120 Hz)或控制(eTNS 2 Hz)参数。结果:在条目,受试者高度耐药,平均每月8.7癫痫(治疗组)和4.8每月发作(主动控制)。平均而言,受试者没有3.35抗癫痫药物在入学之前,癫痫的平均持续时间为21.5年(治疗组)和23.7年(主动控制集团),分别。eTNS耐受良好。副作用包括焦虑(4%)、头痛(4%),和皮肤过敏(14%)。应答率,定义为在癫痫发作频率减少50%,治疗组为30.2% vs 21.1%为主动控制集团18-week治疗期(不显著,p = 0.31,广义估计方程(GEE)模型)。治疗组经历了一个显著的类内提高应答率18-week治疗期间(从17.8%在18周6周的40.5%,p = 0.01,哇)。 Subjects in the treatment group were more likely to respond than patients randomized to control (odds ratio 1.73, confidence interval 0.59–0.51). eTNS was associated with reductions in seizure frequency as measured by the response ratio (p = 0.04, analysis of variance [ANOVA]), and improvements in mood on the Beck Depression Inventory (p = 0.02, ANOVA).Conclusions: This study provides preliminary evidence that eTNS is safe and may be effective in subjects with DRE. Side effects were primarily limited to anxiety, headache, and skin irritation. These results will serve as a basis to inform and power a larger multicenter phase III clinical trial.Classification of evidence: This phase II study provides Class II evidence that trigeminal nerve stimulation may be safe and effective in reducing seizures in people with DRE.AED=antiepileptic drug; ANOVA=analysis of variance; BDI=Beck Depression Inventory; DRE=drug-resistant epilepsy; eTNS=external trigeminal nerve stimulation; GEE=generalized estimating equation; GTC=generalized tonic-clonic seizure; HR=heart rate; IRB=institutional review board; OR=odds ratio; TNS=trigeminal nerve stimulation; VNS=vagus nerve stimulation ER -