INTRACTABLE EPILEPSY--PRESURGICAL STRATEGY AND OUTCOME

手术越来越多地被用作治疗医学上难以治愈的疾病的方法。 癫痫，前颞叶切除术（ATL）是最常见的手术 procedure. 然而，很少有对照或前瞻性研究 用于定位可切除的致癫痫区域的测试或 ATL的全面成果。 本研究的长期目标是 制定一项战略，通过非侵入性测试， 难治性癫痫患者的可能数量， ATL成功治疗并确定ATL的综合结局 使用多种措施。 预期结果将减少 需要长期颅内脑电图（EEG）的患者 并将提供关键信息，以便进行更全面的 和适当的术前知情同意程序。 的具体目标 该研究将：21）确定一种准确、有效和成本效益 非侵入性测试算法，选择大多数患者， 难治性癫痫谁可以成功地治疗ATL，2）确定 ATL使用多种功能、生活质量 和癫痫发作; 3）确定ATL的发病率和死亡率。 的 研究是一项前瞻性、非随机对照试验，分为两部分 阶段;第一阶段测试非侵入性算法，第二阶段确定 全面的成果。 算法中的预测变量基于 分析发作间期EEG、电图和临床癫痫发作， 视频/EEG监测，神经系统检查，发热史 惊厥，磁共振成像（MRI）显示海马异常， 以及MR上肌酸/N-乙酰天冬氨酸比值的增加 谱 加权测试标准的组合将确定 不需要颅内监测确认的ATL候选资格 癫痫区 第一阶段的成果计量已经完成 停止癫痫发作。 第二阶段的预测变量是ATL。 的 第二阶段的结果指标是癫痫发作停止，生活质量， 神经心理功能，精神状况，职业和教育 成就感和患者满意度。 生活质量，神经心理学 功能和精神状态将由先前的 标准化和有效的测试。 将重复所有结局指标 每例受试者每年一次，直至研究结束;入组期 将为4年，以便所有患者至少有1年的时间 随访 75%的受试者将接受两次以上的随访 年 对照组为经以下方法确诊的颞叶癫痫患者： 推迟手术或最终不是候选者算法 切除手术（即，双颞癫痫发作），并随访 最少1年。 I期的统计分析将包括逻辑分析 回归分析，至首次癫痫发作时间的比例风险模型， 和一个逐步的过程。 第二阶段统计分析将包括， 适当的分类格式（卡方或Fisher精确检验）， 重复测量分析，交互作用评估和ANOVA， 协方差调整

Surgery is being used increasingly as a treatment for medically intractable epilepsy, and anterior temporal lobectomy (ATL) is the most common surgical procedure. However, there are very few controlled or prospective studies of the tests employed to localize a resectable epileptogenic region or of comprehensive outcome from ATL. The long-term objectives of this study are to develop a strategy that will identify by noninvasive tests the largest possible number of patients with intractable epilepsy who can be successfully treated with ATL and determine comprehensive outcome from ATL using multiple measures. The expected results will decrease the number of patients who require long-term intracranial electroencephalography (EEG) prior to surgery and will provide critical information for a more complete and appropriate presurgical informed consent process. The specific aims of the study are to; 21) determine an accurate, efficient, and cost-effective algorithm of noninvasive tests that selects a majority of patients with intractable epilepsy who can be treated successfully by ATL, 2) determine the outcome from ATL using multiple measures of function, quality of life, and seizures, and 3) determine the morbidity and mortality from ATL. The study is a prospective, nonrandomized controlled trail divided into two phases; phase I tests the noninvasive algorithm and phase II determines comprehensive outcome. The predictor variables in the algorithm are based on interictal EEG, electrographic and clinical seizures analyzed by video/EEG monitoring, neurological examination, history of febrile convulsions, hippocampal abnormality on magnetic resonance imaging (MRI), and an increased temporal creatine/N-acetyl aspartate ration on MR spectroscopy. Combinations of weighted test criteria will determine candidacy for ATL without requiring intracranial monitoring conformation of the epileptogenic zone. The outcome measure for phase I is complete cessation of seizures. The predictor variable for phase II is ATL. The outcome measures for phase II are seizure cessation, quality of life, neuropsychological function, psychiatric status, vocational and educational achievement, and patient satisfaction. Quality of life, neuropsychological function, and psychiatric status will be assessed by previously standardized and validated tests. All outcome measures will be repeated yearly on each subject until the end of the study; the enrollment period will be four years so that all patients will have a minimum of 1 year follow-up. Seventy-five percent of subjects will be followed for more two years. Controls will be patients with temporal lobe epilepsy confirmed by the algorithm who defer surgery or are ultimately not candidates for resective surgery (i.e., bitemporal seizure onset) and are followed for a minimum of 1 year. Statistical analysis of phase I will include logistic regression analysis, proportional hazards model for time to first seizure, and a step-wise procedure. Phase II statistical analysis will include as appropriate a categorical format (chi square or Fisher's Exact test), repeated measures analysis, interaction assessment, and ANOVA with covariance adjustment.