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Completed

NCT Number: NCT02516787

Coherence Between Brain Cortical Function and Neurocognitive Performance During Changed Gravity Conditions

Alongside a well-known physiological deconditioning, such as a decrease in muscle mass or bone demineralization, extended stays in weightlessness also cause cognitive dysfunction. However, the studies on this subject during space missions short or long term could not determine how these cognitive dysfunction resulted from a direct effect of weightlessness or a stress-related effect.

Analysis of electro-encephalography (EEG) using a standardized mapping method is used to study the changes of operation of the cerebral cortex as the near infrared spectroscopy (NIRS) is a reflection of changes in the cerebral hemodynamics. Their combined use is a relatively simple and economical method for studying brain changes in an environment where the normal brain imaging techniques can not be used.

The main objective of this experiment is to evaluate the alterations in brain cortical activity and brain oxygenation level induced by micro- and hypergravity conditions.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umr Ucbn/Inserm U1075 Comete

Caen, Basse-Normandie, 14032, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteers (men or women),
  • aged from 18 to 65,
  • affiliated to a Social Security system and, for non-French resident, holding an European Health Insurance Card (EHIC)
  • who accept to take part in the study,
  • who have given their written stated consent,
  • who already participated in parabolic flights (even in the same campaign)
  • All subjects will pass 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.

Exclusion criteria

  • Persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated,
  • Persons with prior serious injuries to their head
  • Persons who take any medication or drugs influencing their central nervous system or cognitive performance
  • Pregnant women.

Treatment and study plan

Parabolic flight

Other

EEG measurement

Other

Electro cortical power in alpha frequency ranges (EEG-LORETA)

NIRS measurements

Other

Brain tissue oxygenation ( oxy- or deoxygenated hemoglobin values) - NIRS

Primary outcomes

  1. alterations in brain cortical activity (EEG)

    Time frame: baseline

  2. brain oxygenation level (NIRS)

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: CORTICOG

Important dates

Study start
2010
Primary completion
2013
First posted
Aug 6, 2015
Registry last updated
Aug 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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