跳至主要内容
临床试验/NCT04451278
NCT04451278招募中不适用

RESting-state Functional MRI for Prediction of Post-surgical Prognosis In Pediatric Drug-Resistant Epilepsy

Fondation Ophtalmologique Adolphe de Rothschild2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Determine the prognostic value of topological parameters measured on local r-fMRI on the surgical success at one year of patients operated for drug-resistant epilepsy.

研究概览

简要总结

Resting-state functional MRI (r-fMRI) has emerged in recent years to analyze resting networks. It allows, without active participation of the patients, to identify and analyze the different functional brain networks. The analysis of r-fMRI can be done thanks to the graph theory, which is based on the based on the calculation of quantifiable parameters applied to the functional network studied, making it possible to assess its effectiveness.

To the knowledge of the investigators, no study has used graph theory applied to r-fMRI data in order to obtain parameters useful for the useful parameters for the individual prognosis of children who have to be operation for drug-resistant lesional epilepsy.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient aged between 6 and 18 years
  • Receiving an MRI for lesional drug-resistant epilepsy
  • Affiliated or beneficiary of a social security plan
  • Whose parents or guardians have received information about the study and have given their express consent to participate in the study

排除标准

  • Contraindication to absolute or relative MRI (in particular, pregnant or breastfeeding women)
  • History of intracranial surgery
  • MRI performed under general anesthesia

结局指标

主要结局

Determine the prognostic value of topological parameters measured on local r-fMRI on the surgical success at one year of patients operated for drug-resistant epilepsy.

时间窗: One year

The variables measured with functional MRI will correspond to topological parameters of functional connectivity measured locally at the level of the lesion: the degree, the clustering coefficient and path length. Surgical success will be evaluated by a score of 1 on the modified Engel classification at one year after surgery.

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (2)

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