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

NCT02516787 | Completed

• 1 other identifier: 10-082
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (2)

• alterations in brain cortical activity (EEG)

  baseline

• brain oxygenation level (NIRS)

  baseline

Study Arms (1)

EEG and NIRS measurements

OTHER

Other: Parabolic flight; Other: EEG measurement; Other: NIRS measurements

Interventions

Parabolic flight OTHER

EEG and NIRS measurements

EEG measurement OTHER

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

EEG and NIRS measurements

NIRS measurements OTHER

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

EEG and NIRS measurements

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Umr Ucbn/Inserm U1075 Comete

Caen, Basse-Normandie, 14032, France

Location

Study Design

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

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: August 6, 2015
• Study Start: November 1, 2010
• Primary Completion: November 1, 2013
• Last Updated: August 6, 2015

Record last verified: 2015-08

Locations

FR (1)