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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02789007
Other study ID # 2015-A02014-45
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date September 2019

Study information

Verified date November 2016
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of this experiment is to assess the impact of parabolic flight on (1) spatial memory and orientation, (2) the changes in brain structure and function, and particularly the hippocampal formation, and (3) biochemical markers of stress and neuroplasticity. A preliminary study will be performed with the aims (1) to test during weightlessness hardware used to administer visuo-spatial testing and (2) to determine the optimal body posture for testing under microgravity conditions (i.e. body posture for which change in visuo-spatial testing induced by weightlessness is maximal). The main criteria are: - Structural and functional changes of brain evaluated by fMRI; - Cognitive performance, and specifically spatial cognition using a series computer-based tasks. - Key neurotrophins determined in venous blood samples The criteria used in the preliminary experiment is visuo-spatial performance evaluated with a computer-based test assessing spatial cognition. The investigators hypothesize that hippocampal structure and function, and particularly the dentate gyrus, will be altered after parabolic flight compared to ground based controls. Specifically, the 3 tested hypotheses are: - Parabolic flight induces changes in hippocampal structure; - Weightlessness induces changes in cognitive performance, and specifically spatial cognition; - There is a correlation between changes in hippocampal structure and changes in visuo-spatial memory performance. - There is a correlation between changes in hippocampal structure and changes in key neurotrophins. The hypothesis tested during the preliminary experiment is that body posture affects the changes in spatial cognition performance.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date September 2019
Est. primary completion date March 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 67 Years
Eligibility Inclusion Criteria: - Healthy volunteers (men or women) - Aged from 18 to 67 - 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 - Person with medical history of claustrophobia - Person with contraindication to MRI - Pregnant women

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Assess the impact of parabolic flight
MRI testing will be performed using a 3T MRI facility in Bordeaux close to Novespace (CHU Pellegrin). Spatial cognition will be assessed using a battery of in-house virtual paradigms General cognitive performance testing will include a wide range of cognitive functions, and particularly executive control using the Cognition Battery Mental status will be assessed on a tablet computer using a visual analogue scale Vigilant attention will be determined using the 3-min Psychomotor Vigilance Test (PVT) Blood samples (5 mL per collection) will be collected prior to neuroimaging by venepuncture

Locations

Country Name City State
France Caen CHU Caen

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Caen Novespace

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Structural and functional changes of brain evaluated by fMRI baseline
Secondary Spatial Cognitive performance using a series computer-based tasks baseline
Secondary Key neurotrophins determined in venous blood samples baseline
Secondary visuo-spatial performance evaluated with a computer-based test assessing spatial cognition. baseline
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