Parabolic Flight Induced Neuroplasticity Studied With Advanced Magnetic Resonance Imaging Methods (BrainDTI)

Weightlessness profoundly modifies many physiological systems and especially the nervous system and the vestibular system. The changes in the nervous system are based in part on brain plasticity mechanisms, that is to say on modifications of neurons and their connections. They are the source of some of the behavioral response observed in the parabolic flight or in astronauts. For example, it is commonly observed that in the second and third days of parabolic flight campaigns with 3 flights, fewer participants are prone to motion sickness during the first day. Similarly, during their first trip into space, astronauts suffer 2/3 for 2 or 3 days of space sickness - special form of motion sickness - while this proportion is much lower in the second trip.

The hypothesis of this study is that short-term weightlessness as well as changes in the level of gravity experienced during parabolic flights, induce neuroplascity phenomena in brain regions involved in the integration of vestibular, visual and proprioceptive.

The goal is to objectify these plasticity phenomena, and assess their changes over time, using methods of Magnetic Resonance Imaging (MRI). A standard MRI will give an anatomical image of the brain. For this study, a variant called diffusion MRI (Diffusion Tensor Imaging - DTI) will visualize nerve bundles and their journey in the brain. The total duration of this review will be about ¾ hour.

The results of this study will be compared with those of an ongoing study of 12 astronauts who have the same MRI scans taken before and after a trip to the International Space Station. Investigators can then evaluate the effect of duration of exposure to weightlessness on the phenomena of neuroplasticity.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Device: MRI; Other: parabolic flight

• Study Type: Interventional
• Enrollment (Anticipated): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Basse-Normandie
    • Caen CEDEX, Basse-Normandie, France, 14032
      • Recruiting
      • Umr Ucbn/Inserm U1075 Comete

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Healthy volunteers (men or women)

  • Aged from 21 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. There will be no additional test performed for subject selection.
  • Who has already been included in the Belgium part of this experiment and thus has signed the Belgium informed consent.

Exclusion Criteria:

• • Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated

  • Person who has participated in a parabolic flight in the 2 previous years
  • Person with medical history of claustrophobia
  • Person with countraindication to MRI
  • Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: parabolic flight and MRI scans	Device: MRI; Other: parabolic flight

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
biomarkers of neuroplasticity with MRI	to identify biomarkers of neuroplasticity in the brain by comparing images before and after parabolic flight using advanced MRI methods	change over baseline and 6 months
time course of possible changes and signs of neuroplasticity with MRI		change over baseline and 6 months
motion sickness questionnaires	to link biomarkers of brain plasticity with clinical outcome - obtained by motion sickness questionnaires	change over baseline and 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ANTICIPATED): April 1, 2017

Study Registration Dates

• First Submitted: July 21, 2015
• First Submitted That Met QC Criteria: August 5, 2015
• First Posted (ESTIMATE): August 6, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): August 6, 2015
• Last Update Submitted That Met QC Criteria: August 5, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: volunteers
• Other Study ID Numbers: 14-004