- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02789007
Effects of Parabolic Flight on Spatial Cognition and Hippocampal Plasticity (HypoCampus)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Caen, France, 14000
- Caen CHU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: parabolic flight
To evaluate Structural and functional changes, Cognitive performance, and specifically spatial cognition, Key neurotrophins...
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Structural and functional changes of brain
Time Frame: baseline
|
evaluated by fMRI
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spatial Cognitive performance
Time Frame: baseline
|
using a series computer-based tasks
|
baseline
|
|
Key neurotrophins
Time Frame: baseline
|
determined in venous blood samples
|
baseline
|
|
visuo-spatial performance
Time Frame: baseline
|
evaluated with a computer-based test assessing spatial cognition.
|
baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pierre DP Denise, PhD, CHU Caen
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2015-A02014-45
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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