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临床试验/NCT02899832
NCT02899832已完成不适用

A Study of Hemodynamic Changes Using Near Infra-red Spectrometry (NIRS) in Infantile Epilepsy Spasms

Centre Hospitalier Universitaire, Amiens4 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2013年2月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
4
主要终点
changes in Hbr

研究概览

简要总结

This study will included 20 children presenting with epilepsy with spasms. It aims to offer these children, non invasively and without supplementary examinations, a recording of local and cerebral hemodynamic changes concomitant with an electroencephalographic recording during epileptic episodes. This will be carried out by combining optical imaging using near infra-red spectroscopy (NIRS) with electroencephalography (EEG), in a simultaneous high-resolution (HR) recording.

This study is among those based on multimodal analyses of epilepsy, combining methods of analysis of electrical activity (electrical imaging) and hemodynamics (optical imaging).

Surface electroencephalography (EEG) is a precious tool enabling the study of neuronal dysfunction from a functional point view. It is used in the routine follow-up of children with epilepsy. Optical imaging is a promising medical imaging technique. It uses light in the spectral regions of near infra-red as a source of radiation. It is quantitative, rapid, non invasive, and inoffensive which could easily be used at the child's bedside or in a clinical setting and can provide metabolic information about cerebral function.

This study is multidisciplinary, which calls upon the skills of neurophysiologists, biophysicists, and clinicians

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
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between 3 and 6 years old presenting infantile spasms according to the Classification of the International League Against Epilepsy

排除标准

  • Children younger than 3 months and older than 6 years of age, refusal of one of the parents, and dermatosis of the scalp

结局指标

主要结局

changes in Hbr

时间窗: Day 0

hemodynamic changes in \[Hbr\] before spasms, during spasms, and after spasms

changes in HbO

时间窗: Day 0

hemodynamic changes in \[HbO\] before spasms, during spasms, and after spasms

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 (4)

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