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Neurocognitive Performance During Space Flight. Validation of a Test Battery (NeuroCog)

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ClinicalTrials.gov Identifier: NCT02805400
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : June 20, 2016
Last Update Posted : June 20, 2016
Sponsor:
Collaborator:
Novespace
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:

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

A secondary objective is to correlate changes in brain cortical activity and brain oxygenation level with neurocognitive performance.

Another secondary objective is to differentiate between the influences of hemodynamic and electro cortical changes and the influence of stress on cognitive performance alterations


Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: determination of cortical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Neurocognitive Performance During Space Flight. Validation of a Test Battery
Study Start Date : April 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Arm Intervention/treatment
Neurocognitive performance

Cortical activity will be determined under changing gravity level by electroencephalography (EEG/LORETA). Brain hemodynamics change will be evaluated by NIRS. Heart rate and respiratory evaluation will be indicators of cardio-vascular and central nervous arousal and stress. Cognitive performance will be evaluated by computerized tests.

For these methods only commercially available CE marked devices will be used.

Other: determination of cortical activity

Cortical activity will be determined under changing gravity level by electroencephalography (EEG/LORETA). Brain hemodynamics change will be evaluated by NIRS. Heart rate and respiratory evaluation will be indicators of cardio-vascular and central nervous arousal and stress. Cognitive performance will be evaluated by computerized tests.

For these methods only commercially available CE marked devices will be used.





Primary Outcome Measures :
  1. brain cortical activity induced by micro- and hypergravity conditions : Electro cortical power in alpha frequency ranges (EEG-LORETA) [ Time Frame: baseline ]
  2. Brain tissue oxygenation ( oxy- or deoxygenated hemoglobin values) NIRS [ Time Frame: baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers (men or women)
  • Aged from 18 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 (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

Exclusion Criteria:

  • Person 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805400


Contacts
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Contact: Pierre DP Denise, PhD 02.31.06.81.32 ext +33 pierre.denise@unicaen.fr
Contact: Cathy GC Gaillard 02 31 06 53 49 ext +33 gaillard-c@chu-caen.fr

Locations
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France
Caen CHU Recruiting
Caen, France, 14000
Sponsors and Collaborators
University Hospital, Caen
Novespace
Investigators
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Principal Investigator: Pierre DP Denise, PhD CHU Caen
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02805400    
Other Study ID Numbers: 2015-A00044-45
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No