跳至主要内容
临床试验/NCT02799108
NCT02799108终止不适用

Analysis of Lateralization of Language in Epileptic Children by Near-infrared Spectroscopy (NIRS)

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2012年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
1
主要终点
lateralization index

研究概览

简要总结

Recent data published by various laboratories as well as our preliminary data tend to prove that near-infrared spectroscopy can be used to determine the lateralization of language as part of the preoperative assessment for drug-resistant epilepsy. The reference test used up until very recently was the Wada test, which consisted of injecting an anaesthetic (generally amobarbital sodium) into one of the internal carotid arteries (right or left) in order to determine the predominant cerebral hemisphere for language. This invasive test has been progressively replaced by fMRI, which is nevertheless difficult to perform in children under the age of 7 years. NIRS therefore appears to be a useful alternative, which, in contrast with fMRI, can be easily repeated and allows simple investigation of the various facets of language (e.g. expressive, receptive). In the GRAMFC unit, the investigators have acquired a unique know-how in the field of high-resolution NIRS, both in epilepsy and in the development of language structures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

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
否

入选标准

  • •children with drug-resistant partial epilepsy, in whom preoperative assessment is indicated.

排除标准

  • •All children with severe congenital malformation
  • •Any refusal of a parent or child
  • •Any child with generalized epilepsy or diffuse interictal spikes
  • •Any child with a serious deterioration in the general condition and vital functions
  • •Any child with dermatitis of the face or scalp
  • •Children under 6 years

研究组 & 干预措施

patients

Experimental

children with drug-resistant partial epilepsy, in whom preoperative assessment is indicated

干预措施: NIRS (Device)

patients

Experimental

children with drug-resistant partial epilepsy, in whom preoperative assessment is indicated

干预措施: fMRI (Device)

结局指标

主要结局

lateralization index

时间窗: 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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