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临床试验/NCT02588482
NCT02588482终止不适用

Comparison Between High-density Electroencephalography and Conventional Electroencephalography to Diagnose the Presence of Consciousness in Post-anoxic Comatose Patients

Centre Hospitalier Universitaire de Besancon1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年6月17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
50
试验地点
1
主要终点
Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography

研究概览

简要总结

The purpose of this study is to measure whether high-density electroencephalography can improve the detection of electrophysiological signs of awareness compared to conventional electroencephalography in post-anoxic comatose patients

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •post anoxic coma
  • •over 18 years old
  • •agreement from families
  • •alive 4 days after the beginning of coma

排除标准

  • •traumatic coma
  • •non-traumatic but not anoxic coma
  • •patients with severe comorbidity previous to coma
  • •refusal of families to participate to the study
  • •contraindication to a high-density electroencephalography exam

研究组 & 干预措施

electroencephalography recording

Experimental

Cerebral measurements from high-density and conventional electroencephalography are recorded simultaneously

干预措施: high-density electroencephalography (Device)

electroencephalography recording

Experimental

Cerebral measurements from high-density and conventional electroencephalography are recorded simultaneously

干预措施: Conventional electroencephalography (Device)

结局指标

主要结局

Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography

时间窗: 4 days after the beginning of coma

mismatch negativity is an electrophysiological response recorded after the presentation of deviant auditory stimulations Recovery is assessed 1 month after the beginning of coma

次要结局

  • Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography(19 days after the beginning of coma)
  • Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography(7 days after the beginning of coma)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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