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