Early Randomized Surgical Epilepsy Trial

描述(由申请人提供)：这项早期随机外科癫痫试验(ERSET)的拨款申请最初是在计划拨款R21 NS37897的帮助下准备的，该拨款是为了承认这样一个事实，即内侧颞叶癫痫(MTLE)是一种可手术补救的综合征，这种疾病的外科治疗没有得到充分利用，而且在手术和继续治疗的相对好处方面存在真正的平衡。 新的抗癫痫药物，在疾病的早期。我们现在提交一项多中心随机对照试验(RCT)的修订方案，以比较MTLE早期手术干预和持续最佳药物治疗的疗效。主要结果衡量标准将是使癫痫患者免于癫痫发作(复杂的部分性和继发性全身性发作，以及观察者明显的简单部分性发作)。12岁的病人 1)对两种或两种以上的抗癫痫药物没有反应，其中一种必须是苯妥英钠、替格列托或卡巴特罗，2)根据定义的标准，没有持续两年以上。分布在全国各地的15家癫痫手术中心将积极招聘 符合这些标准的患者。这些患者将接受严格的、跨中心标准化的术前评估方案，然后200名外科候选人将被随机分为前内侧颞叶切除术或两年的额外药物治疗。研究将检验五个假设：1)手术治疗将比内科治疗更有效地减少癫痫发作的频率和严重程度；2)手术治疗将比内科治疗更有效地改善生活质量；3)手术治疗将比内科治疗更有效地改善心理和社会功能；4)与手术治疗相关的发病率和死亡率不会高于与内科治疗相关的发病率和死亡率 治疗；以及5)进行性海马区萎缩和近侧颞叶代谢不足只会发生在持续频繁的复杂部分性和全身性强直-阵挛发作的患者。

DESCRIPTION (provided by applicant): This grant application for an early randomized surgical epilepsy trial (ERSET) was originally prepared with the help of planning grant R21 NS37897, awarded in recognition of the fact that mesial temporal lobe epilepsy (MTLE) is a surgically remediable syndrome, that surgical treatment for this disorder is underutilized, and that true equipoise exists concerning the relative benefits of surgery vs. continued treatment with new antiepileptic drugs, early in the course of the disorder. We now submit a revised proposal for a multicenter randomized controlled trial (RCT) to compare the efficacy of early surgical intervention for MTLE with continued optimal pharmacotherapy. The primary outcome measure will be freedom from disabling epileptic seizures (complex partial and secondarily generalized seizures, and simple partial seizures that are apparent to an observer). Patients aged 12 years and older with suspected MTLE will be candidates for recruitment if disabling seizures: 1) have not responded to two or more antiepileptic drugs, one of which must be either Dilantin, Tegretol, or Carbatrol, and 2) have not persisted, according to defined criteria, for more than two years. Fifteen epilepsy surgery centers spaced evenly across the country will actively recruit patients meeting these criteria. These patients will undergo a rigid presurgical evaluation protocol, standardized across centers, and 200 surgical candidates will then be randomized to either anteromesial temporal resection or two years of additional pharmacotherapy. Studies will test five hypotheses: 1) Surgical treatment will be more effective than medical treatment in reducingthe frequency and severity of epileptic seizures; 2) Surgical treatment will be more effective than medical treatment in improving quality of life; 3) Surgical treatment will be more effective than medical treatment in improving psychological and social function; 4) Morbidity and mortality associated with surgical treatment will be no greater than that associated with medical treatment; and 5) Progressive hippocampal atrophy and mesial temporal hypometabolism will occur only in patients who continue to have frequent complex partial and generalized tonic-clonic seizures.