跳至主要内容
临床试验/NCT04642573
NCT04642573招募中不适用

The Metabolic Characteristics in Sublobar Areas of Pharmacoresistant Epilepsy Based on FDG-PET Study

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年11月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
hypometabolic patterns for each patient group comparing with control group

研究概览

简要总结

Epilepsy is a chronic brain disease that is caused by various factors and characterized by recurrent, episodic and temporary central nervous system dysfunction. In the past few decades, despite the continuous development of antiepileptic drugs, there are still 20%-30% patients with epilepsy progressing to pharmacoresistant epilepsy (PRE), which leads to a significant increase in the morbidity and mortality of epilepsy. For those fraction of PRE, surgical treatment may be the only possible way to cure epilepsy. Accurate presurgical evaluation play an important role in making surgery decision and defining surgical extent and achieve better surgical outcome. Imaging, especially interictal fluorine-18-fluorodeoxyglucose-positron emission tomography (FDG-PET) is widely used in preoperative evaluation, which is of great significance in the detection of epileptogenic foci. Previous studies on FDG-PET have found that FDG-PET has a wide range of hypometabolism inpatients of PRE varying from different epileptic origins. Therefore, exploring the characteristics of glucose metabolism originating in different brain areas of resistant epilepsy can help to better interpret the results of FDG-PET and guide the preoperative localization of such patiens and better understand the potential mechanism of seizure propagation in PRE.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
3 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • (a) Pharmacoresistant Epilepsy may be defined by International League Against Epilepsy (ILAE)as failure of adequate trials of two tolerated and appropriately chosen and used AED schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom (judged by two epileptologists); (b) conventional MRI negative or nonspecific abnormalities; and (c) detailed information of long-term video-EEG, FDG-PET, high resolution MRI (HR-MRI) and neuropsychological assessment were acquired, (d) focal epilepsy defined by combining clinical, electrophysical and neuroimaging.

排除标准

  • (a) generalized or multifocal epilepsy or the patient's electroclinical features were inconsistent with pharmacoresistant epilepsy; (b) idiopathic focal epilepsy; and (c) unsatisfactory imaging quality.

结局指标

主要结局

hypometabolic patterns for each patient group comparing with control group

时间窗: 1-3months

Due to the different epileptogenic zones in each group, the hypometabolic patterns should be different

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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