Early Randomized Surgical Epilepsy Trial

描述（申请人提供）：这项早期随机手术癫痫试验（ERSET）的拨款申请最初是在计划拨款R21 NS 37897的帮助下准备的，该计划拨款是为了表彰内侧颞叶癫痫（MTLE）是一种可手术治疗的综合征，这种疾病的手术治疗未得到充分利用，关于手术与继续治疗的相对获益， 新的抗癫痫药物，在疾病的早期。我们现在提交了一个多中心随机对照试验（RCT）的修订建议，以比较早期手术干预与持续最佳药物治疗MTLE的疗效。主要结局指标是无致残性癫痫发作（复杂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岁患者 如果以下情况导致癫痫发作：1）对两种或两种以上抗癫痫药物无反应，其中一种必须是苯妥英钠、Tegretol或Carbatrol; 2）根据规定的标准，持续时间不超过两年，则年龄≥ 15岁的疑似MTLE患者将成为招募的候选人。全国均匀分布的15个癫痫手术中心将积极招募 符合这些标准的患者。这些患者将接受严格的术前评估方案，标准化的中心，200名手术候选人将被随机分配到前内侧颞叶切除术或两年的额外药物治疗。本研究将检验五个假设：1）手术治疗在降低癫痫发作频率和严重程度方面比药物治疗更有效; 2）手术治疗在改善生活质量方面比药物治疗更有效; 3）手术治疗在改善心理和社会功能方面比药物治疗更有效; 4）与手术治疗相关的发病率和死亡率将不大于与药物治疗相关的发病率和死亡率。 治疗;进行性海马萎缩和内侧颞叶代谢减退仅发生在持续频繁复杂部分性和全身强直阵挛性癫痫发作的患者中。

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.