Neurocognitive Performance During Space Flight. Validation of a Test Battery

NCT ID: NCT02805400

Last Updated: 2016-06-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2018-04-30

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

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

determination of cortical activity

Intervention Type: OTHER

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.

Interventions

determination of cortical activity

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novespace

INDUSTRY

Sponsor Role: collaborator

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre DP Denise, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU CAEN

Locations

Caen CHU

Caen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Pierre DP Denise, PhD

Role: CONTACT

pierre.denise@unicaen.fr

02.31.06.81.32 ext. +33

Cathy GC Gaillard

Role: CONTACT

gaillard-c@chu-caen.fr

02 31 06 53 49 ext. +33

Other Identifiers

2015-A00044-45

Identifier Type: -

Identifier Source: org_study_id