Neurocognitive Performance During Space Flight. Validation of a Test Battery
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 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
- 是
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
研究组 & 干预措施
Neurocognitive performance
Cortical activity will be determined under changing gravity level by electroencephalography (EEG/LORETA). Brain hemodynamics change will be evaluated by NIRS. Heart rate and respiratory evaluation will be indicators of cardio-vascular and central nervous arousal and stress. Cognitive performance will be evaluated by computerized tests.
For these methods only commercially available CE marked devices will be used.
干预措施: determination of cortical activity (Other)
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