Healthy Volunteers Clinical Trial
— HypoCampusOfficial title:
Effects of Parabolic Flight on Spatial Cognition and Hippocampal Plasticity
| Verified date | November 2016 |
| Source | University Hospital, Caen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Caen CHU | Caen |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Caen | Novespace |
France,
| 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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