NCT02789007

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

February 17, 2026

Status Verified

November 1, 2016

Enrollment Period

3 years

First QC Date

April 21, 2016

Last Update Submit

February 13, 2026

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Structural and functional changes of brain

    evaluated by fMRI

    baseline

Secondary Outcomes (3)

  • Spatial Cognitive performance

    baseline

  • Key neurotrophins

    baseline

  • visuo-spatial performance

    baseline

Study Arms (1)

parabolic flight

OTHER

To evaluate Structural and functional changes, Cognitive performance, and specifically spatial cognition, Key neurotrophins...

Other: Assess the impact of parabolic flight

Interventions

Assess the impact of parabolic flightOTHER

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

parabolic flight

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Person with medical history of claustrophobia
  • Person with contraindication to MRI
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen CHU

Caen, 14000, France

Location

Related Publications (1)

  • Stahn AC, Riemer M, Wolbers T, Werner A, Brauns K, Besnard S, Denise P, Kuhn S, Gunga HC. Spatial Updating Depends on Gravity. Front Neural Circuits. 2020 Jun 5;14:20. doi: 10.3389/fncir.2020.00020. eCollection 2020.

    PMID: 32581724RESULT

Study Officials

  • Pierre DP Denise, PhD

    CHU CAEN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2016

First Posted

June 2, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2019

Study Completion

September 1, 2019

Last Updated

February 17, 2026

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)