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

NCT ID: NCT02516787

Last Updated: 2015-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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EEG and NIRS measurements

Group Type OTHER

Parabolic flight

Intervention Type OTHER

EEG measurement

Intervention Type OTHER

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

NIRS measurements

Intervention Type OTHER

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

Interventions

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Parabolic flight

Intervention Type OTHER

EEG measurement

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

Intervention Type OTHER

NIRS measurements

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Umr Ucbn/Inserm U1075 Comete

Caen, Basse-Normandie, France

Site Status

Countries

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France

Other Identifiers

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10-082

Identifier Type: -

Identifier Source: org_study_id

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