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Neurocognitive Performance During Space Flight. Validation of a Test Battery

Not Applicable
Conditions
Healthy Volunteers
Interventions
Other: determination of cortical activity
Registration Number
NCT02805400
Lead Sponsor
University Hospital, Caen
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
24
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Neurocognitive performancedetermination of cortical activityCortical 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.
Primary Outcome Measures
NameTimeMethod
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) NIRSbaseline
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Caen CHU

🇫🇷

Caen, France

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