Neurocognitive Performance During Space Flight. Validation of a Test Battery

NCT02805400 | Unknown

• 1 other identifier: 2015-A00044-45
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• brain cortical activity induced by micro- and hypergravity conditions : Electro cortical power in alpha frequency ranges (EEG-LORETA)

  baseline

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

  baseline

Study Arms (1)

Neurocognitive performance

OTHER

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

Interventions

determination of cortical activity OTHER

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.

Neurocognitive performance

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 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

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
• Novespace: collaborator

Study Sites (1)

Caen CHU

Caen, 14000, France

RECRUITING

Study Officials

• Pierre DP Denise, PhD

  CHU CAEN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre DP Denise, PhD

CONTACT

02.31.06.81.32; pierre.denise@unicaen.fr

Cathy GC Gaillard

CONTACT

02 31 06 53 49; gaillard-c@chu-caen.fr

Study Design

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

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: June 20, 2016
• Study Start: April 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 20, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)