RADIOSURGICAL TREATMENT OF TEMPORAL LOBE EPILEPSY

描述(申请人摘要)：这项研究的目的是确定 伽玛刀放射外科治疗是否有效减少或消除 颞叶癫痫患者的癫痫发作。主要的假设是 内侧颞叶结构的放射外科治疗，包括 杏仁核和海马区，将导致癫痫发作的显著减少 药物难治性内侧颞叶癫痫患者 对患者的发病率。 难治的患者(占癫痫患者的20%) 可能会转诊为外科治疗。大约有一半的人被发现 作为手术切除癫痫灶的候选人，最常见的是 通过颞叶切除术。开放的外科手术有固有的风险，包括 脑部受损，出血和感染。 放射外科是一种聚焦伽马辐射的技术(201个放射源) 使用立体定向引导进入精确控制的大脑区域。这个 这一手术的主要风险是对附近重要部位的辐射损伤。 结构，以及放射性坏死。有初步证据表明 高剂量辐射可减少癫痫发作，但长期结果可在 很少有案例。最佳辐射剂量，最低有效治疗 这一方法的真正发病率尚未确定。 这个方案定义了一组同质的内侧颞叶患者 开腹手术的结果已经确定的癫痫。会的 比较两种针对内侧颞叶的放射外科剂量 标准的医疗疗法。放射外科治疗将全面标准化 使用伽玛刀独有的中心间数据传输的治疗中心 乐器。关于癫痫发作频率(包括无癫痫发作)的随访数据 结果)、神经心理测试、MRI(包括灌注和弥散 加权研究)，MRS结果和脑电变化将收集三个 在放射外科治疗后的几年里。从这个项目获得的试点数据 议定书将导致对安全和有效辐射的更好定义 未来方案中使用的剂量，包括放射外科与 颞叶切除术。如果放射外科手术可以减少或消除 难治性颞叶癫痫患者的癫痫发作 可以提供这种微创技术，避免 开颅手术。

DESCRIPTION (Applicant's Abstract): The purpose of this study is to determine whether gamma knife radiosurgery is effective in reducing or eliminating seizures in patients with temporal lobe epilepsy. The primary hypothesis is that radiosurgical treatment of mesial temporal lobe structures, including the amygdala and hippocampus, will result in a significant reduction in seizures in patients with medically refractory medial temporal lobe epilepsy with minimal morbidity to patients. Patients who are refractory to medical management (20% of epilepsy patients) may be referred for surgical management. Approximately half of them are found to be candidates for surgical resection of their seizure focus, most commonly by temporal lobectomy. Open surgical procedures have inherent risks including damage to the brain, bleeding, and infection. Radiosurgery is a technique whereby gamma radiation is focused (201 sources) using stereotaxic guidance into precisely controlled regions of the brain. The main risks of this procedure are radiation injury to important nearby structures, and radiation necrosis. There is preliminary evidence that high-dose radiation reduces seizures, but long-term outcome is available in very few cases. The optimal radiation dose, the minimum effective treatment volume, and the true morbidity of this approach have not been established. This protocol defines a homogeneous group of patients with mesial temporal lobe epilepsy in whom the outcome from open surgery is well established. It will compare two radiosurgical doses directed at the medial temporal lobe to standard medical therapy. Radiosurgical treatment will be standardized over all Treatment Centers using inter-center data transfer unique to the Gamma Knife instrument. Follow-up data on seizure frequency (including seizure-free outcome), neuropsychological testing, MRI (including Perfusion and Diffusion weighted studies), MRS findings and EEG changes will be collected for three years following radiosurgical treatment. The pilot data obtained from this protocol will result in a better definition of the safe and effective radiation dose for use in future protocols including a comparison of radiosurgery to temporal lobectomy. If radiosurgery can be shown to reduce or eliminate seizures in patients with medically refractory temporal lobe epilepsy, patients could be offered this minimally invasive technique, avoiding the morbidity of open cranial surgery.