Early Randomized Surgical Epilepsy Trial

早期随机癫痫手术试验

• 批准号: 6479154
• 负责人: JEROME NONE ENGEL
• 金额: $ 714.25万
• 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/6479154
• 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）：该赠款申请提前一项早期的随机手术癫痫试验（ERSET）是在计划授予的授予R21 NS37897的帮助下准备的，该授予最初是为了确认米西亚颞叶癫痫（Mtle）的事实，即在外科手术上是可补救的综合症，该综合症是针对该疾病的相对效果，并且是在此疾病的效果，并且是依次的，并且是在此方面的效率，并且是同时发生的。与继续治疗 在疾病过程的早期，新的抗癫痫药。现在，我们提交了一项修订后的多中心随机对照试验（RCT）的建议，以将早期手术干预对MTLE的疗效与持续的最佳药物疗法进行比较。主要结局指标将是免于禁用癫痫发作（复杂的部分和次要的癫痫发作，以及对观察者显而易见的简单局部癫痫发作）。 12岁的患者 如果禁用癫痫发作，则具有可疑MTLE的年龄较大，将是招募的候选者：1）未对两种或更多的抗癫痫药做出反应，其中一种必须是Dilantin，Tegretol或carbatrol，而2）尚未持续下来，根据定义的标准，尚未持久。在全国各地均匀分布的15个癫痫手术中心将积极招募 符合这些标准的患者。这些患者将进行僵化的预性评估方案，该方案跨中心标准化，然后将200名外科手术候选者随机分配给内部临时切除术或两年的其他药物治疗。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将比医学治疗更有效； 2）手术治疗将比医疗改善生活质量更有效； 3）手术治疗将比医疗改善心理和社会功能更有效； 4）与手术治疗相关的发病率和死亡率将不超过与医学相关的发病率和死亡率 治疗; 5）仅在继续经常患有复杂的部分和广义的强调持续性癫痫发作的患者中，才会发生渐进式海马的萎缩和介体时间低代谢。