jRCTs031180191已完成不适用
The clinical trial to evaluate the efficacy of [11C]K-2 in refractory epilepsy patients undergoing anterior temporal lobectomy
未提供0 个研究点目标入组 8 人开始时间: 2017年3月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •1.refractory epilepsy patients(mesial temporal lobe epilepsy)
- •2.patinets for anterior temporal lobectomy(ATL)
- •3.patients who are without cerebral surgery on the same side of ATL
- •4.patients who are 20 years or older
- •5.patients who can consent to this study by oneself
排除标准
- •1.patients who have significant abnormalities insides the brains
- •2.patients who have experienced the electric stimulation therapy
- •3.patients who undergo artificial dialysis
- •4.patients who have severe liver dysfunction
- •5.patients who have tatoo
- •6.claustrophobic patients
- •7.breast-feeding mothers, expecting mothers, females who desire to be a mother
- •8.patients who desire to bear a child within this study period
- •9.patients who take Fycompa
- •10.patients who underwent nuclear medicine examination within one-week before this registarion
- •11.patients who underwent other clinical trials using unapproved nuclear medicine examination within six month before this registarion
- •12.patients who underwent other clinical trials within 12 weeks before this registarion
- •13.patients whom study doctors consider unappropriate
结局指标
主要结局
-
The correlation of the AMPA receptors densities examined by biochemical study and [11C]K-2 PET study
次要结局
- Engel classification and ILAE classification
- Density of AMPA receptors and FDG-PET values
- Cognitive function scores (IQ, MQ)
- Prescribed anti-epileptic drugs
- Adverse events(7 days after PET scan)
研究者
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