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临床试验/NCT02819427
NCT02819427已完成不适用

Concomitant High-resolution Recording of Haemodynamic and Electrical Activities of Children With Typical or Atypical Absence Seizures: Near-infrared Spectroscopy (NIRS) Coupled to Electroencephalography (EEG)

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年4月3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
10
试验地点
2
主要终点
haemodynamic changes

研究概览

简要总结

This study, conducted in children with typical or atypical "absence" epilepsy, will consist of noninvasive recording of the metabolic activity of the brain concomitantly with electroencephalographic recording during seizures without the need for any additional examination. This examination will be performed by combining near-infrared spectroscopy (NIRS) optical imaging and Electroencephalography (EEG) in a simultaneous High-Resolution (HR) recording.

Surface electroencephalography (EEG) is a valuable tool to assess neuronal dysfunction from a functional point of view and is used in the routine follow-up of epileptic children. Optical imaging is a recent and promising medical imaging technique, which uses near-infrared light. This rapid, noninvasive and harmless quantitative technique can be easily used at the child's bedside or in the ward and provides metabolic information on brain functioning.

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 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 3 to 14 years
  • Featuring absence epilepsy with typical or atypical seizures characterized by the presence of spontaneous spike-wave flashes with standard EEG

排除标准

  • All children with severe congenital malformation
  • Any refusal of a parent or child
  • Any child with a serious deterioration in the general condition and vital functions
  • Any child with dermatitis of the face or scalp
  • Children under 3 years old or over 14 years

结局指标

主要结局

haemodynamic changes

时间窗: Day 0

haemodynamic changes by optical imaging, during the 4 interictal, preictal, ictal and postictal phases of absence seizures as defined by EEG analysis

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 (2)

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