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临床试验/NCT01737723
NCT01737723Unknown不适用

Collecting Data for an Electroencephalograph Based Algorithm for Detection of Onset and Deterioration of Acute Ischemic Stroke by Comparison to NIHSS

Neurokeeper Technologies1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Detection of stroke

研究概览

简要总结

The purpose of this study is Collecting data for an Electroencephalograph based algorithm for detection of onset and deterioration of Acute Ischemic Stroke by Comparison to NIHSS.

详细描述

Inclusion criteria study population Age > 18 years old. Acute stroke symptoms onset within 120 hours of inclusion, and as proximate to event as possible.

Acute ischemic moderate or severe hemispheric stroke (assessed as 5 points or more by NIHSS) and including patients treated by t-PA

Exclusion criteria study population Primary intracranial hemorrhage on admission by CT. Significant movement disorder. Previous major hemispheric stroke. Local skull or skin affliction which prevents electrodes application. Any known condition which in the opinion of the investigator may interfere with the protocol implementation.

Inclusion criteria Control Population

Age > 18 years old.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Age > 18 years old.
  • Acute stroke symptoms onset within 120 hours of inclusion, and as proximate to event as possible.
  • Acute ischemic moderate or severe hemispheric stroke (assessed as 5 points or more by NIHSS) and including patients treated by t-PA

排除标准

  • Primary intracranial hemorrhage on admission by CT.
  • Significant movement disorder.
  • Previous major hemispheric stroke.
  • Local skull or skin affliction which prevents electrodes application.
  • Any known condition which in the opinion of the investigator may interfere with the protocol implementation

结局指标

主要结局

Detection of stroke

EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation as assessed by NIHSS score.

次要结局

  • Correlation to severity of stroke

研究者

发起方
Neurokeeper Technologies
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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