跳至主要内容
临床试验/NCT02805400
NCT02805400Unknown不适用

Neurocognitive Performance During Space Flight. Validation of a Test Battery

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
24
试验地点
2
主要终点
brain cortical activity induced by micro- and hypergravity conditions : Electro cortical power in alpha frequency ranges (EEG-LORETA)

研究概览

简要总结

The main objective of this experiment is to evaluate the alterations in brain cortical activity induced by micro- and hypergravity conditions.

A secondary objective is to correlate changes in brain cortical activity and brain oxygenation level with neurocognitive performance.

Another secondary objective is to differentiate between the influences of hemodynamic and electro cortical changes and the influence of stress on cognitive performance alterations

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers (men or women)
  • Aged from 18 to 65
  • Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
  • Who accepted to take part in the study
  • Who have given their written stated consent
  • Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.
  • Subjects will be staff member of the team or of other teams participating in the parabolic flight campaign

排除标准

  • Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
  • Persons with prior serious injuries to their head
  • Persons who take any medication or drugs influencing their central nervous system or cognitive performance
  • Pregnant women

结局指标

主要结局

brain cortical activity induced by micro- and hypergravity conditions : Electro cortical power in alpha frequency ranges (EEG-LORETA)

时间窗: baseline

Brain tissue oxygenation ( oxy- or deoxygenated hemoglobin values) NIRS

时间窗: baseline

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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