Neurocognitive Performance During Space Flight. Validation of a Test Battery

Study Overview
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Brief Summary
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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

Official Title
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Neurocognitive Performance During Space Flight. Validation of a Test Battery

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: determination of cortical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Neurocognitive performance<br>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. | Other: determination of cortical activity<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain cortical activity induced by micro- and hypergravity conditions : Electro cortical power in alpha frequency ranges (EEG-LORETA) |  | baseline | 
| Brain tissue oxygenation ( oxy- or deoxygenated hemoglobin values) NIRS |  | baseline |