Early Randomized Surgical Epilepsy Trial

早期随机癫痫手术试验

• 批准号: 6652067
• 负责人: JEROME NONE ENGEL
• 金额: $ 111.03万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6652067
• 关键词: adolescence (12-20); adult human (21+); atrophy; brain metabolism; carbamazepine; chemotherapy; clinical research; clinical trials; cooperative study; drug screening /evaluation; epilepsy; hippocampus; human morbidity; human subject; interview; longitudinal human study; neuropsychological tests; neurosurgery; outcomes research; partial seizure; patient oriented research; phenytoin; quality of life; questionnaires

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.

描述（由申请人提供）：这项早期随机癫痫手术试验 (ERSET) 的拨款申请最初是在规划拨款 R21 NS37897 的帮助下准备的，该拨款是为了表彰内侧颞叶癫痫 (MTLE) 是一种可通过手术治愈的疾病这一事实。综合征，这种疾病的手术治疗未得到充分利用，并且关于手术与继续治疗的相对益处存在真正的平衡 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) 的修订提案，以比较 MTLE 的早期手术干预与持续最佳药物治疗的疗效。主要结果指标是无致残性癫痫发作（复杂部分性癫痫发作和继发性全身性癫痫发作，以及观察者明显的简单部分性癫痫发作）。 12岁患者 患有疑似 MTLE 的 1 岁及以上疑似 MTLE 患者将成为招募候选者，如果出现致残性癫痫发作：1）对两种或多种抗癫痫药物没有反应，其中一种必须是 Dilantin、Tegretol 或 Carbatrol，并且 2）没有持续存在，根据定义标准，两年以上。全国均匀分布的15家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（跨中心标准化），然后 200 名手术候选者将被随机分配接受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）手术治疗在降低癫痫发作的频率和严重程度方面比药物治疗更有效； 2）手术治疗将比药物治疗更有效地改善生活质量； 3）手术治疗在改善心理和社会功能方面会比药物治疗更有效； 4）与手术治疗相关的发病率和死亡率不会高于与药物治疗相关的发病率和死亡率 治疗; 5) 进行性海马萎缩和内侧颞叶代谢减退仅发生在持续频繁发生复杂部分性和全身强直阵挛发作的患者中。