Neurocognitive Performance During Space Flight. Validation of a Test Battery

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02805400

Acronym

NeuroCog

Enrollment

Registered

2016-06-20

Start date

2015-04-30

Completion date

2018-04-30

Last updated

2016-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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

Interventions

OTHERdetermination 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

France

Contacts

Primary ContactPierre DP Denise, PhD

pierre.denise@unicaen.fr02.31.06.81.32

Backup ContactCathy GC Gaillard

gaillard-c@chu-caen.fr02 31 06 53 49

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026