RADIOSURGICAL TREATMENT OF TEMPORAL LOBE EPILEPSY

描述（申请人摘要）：本研究的目的是确定 伽玛刀放射外科是否能有效地减少或消除 颞叶癫痫患者的癫痫发作。主要假设为 内侧颞叶结构的放射外科治疗，包括 杏仁核和海马体，将导致癫痫发作的显着减少， 患有医学难治性内侧颞叶癫痫的患者， 患者的发病率。 药物治疗难治性患者（20%癫痫患者） 可能需要进行手术治疗。其中约有一半被发现 手术切除癫痫病灶，最常见的是 颞叶切除术开放性外科手术具有固有风险，包括 大脑损伤出血和感染 放射外科是一种聚焦伽马辐射的技术（201个源） 使用立体定位引导进入大脑的精确控制区域。的 该手术的主要风险是对附近重要部位的辐射损伤。 结构和放射性坏死。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 非常少的案例。最佳辐射剂量，最低有效治疗 量，以及这种方法的真正发病率尚未确定。 该方案定义了一组同质的内侧颞叶患者， 癫痫患者中，开放手术的结果已经确定。它将 比较两种针对内侧颞叶的放射外科剂量， 标准的药物治疗放射外科治疗将全面标准化 使用伽玛刀特有的中心间数据传输的治疗中心 仪器癫痫发作频率的随访数据（包括无癫痫发作） 结果）、神经心理学测试、MRI（包括灌注和弥散 加权研究），MRS结果和EEG变化将收集三个 放射外科治疗后3年。由此获得的试点数据 协议将导致更好地定义安全和有效的辐射 用于未来方案的剂量，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，避免发病率 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.