Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-02-20 @ 4:34 PM
Study NCT ID:
NCT02805400
Status:
UNKNOWN
Last Update Posted:
2016-06-20
First Post:
2016-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurocognitive Performance During Space Flight. Validation of a Test Battery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-15', 'studyFirstSubmitDate': '2016-04-21', 'studyFirstSubmitQcDate': '2016-06-15', 'lastUpdatePostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'brain cortical activity induced by micro- and hypergravity conditions : Electro cortical power in alpha frequency ranges (EEG-LORETA)', 'timeFrame': 'baseline'}, {'measure': 'Brain tissue oxygenation ( oxy- or deoxygenated hemoglobin values) NIRS', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The main objective of this experiment is to evaluate the alterations in brain cortical activity induced by micro- and hypergravity conditions.\n\nA secondary objective is to correlate changes in brain cortical activity and brain oxygenation level with neurocognitive performance.\n\nAnother secondary objective is to differentiate between the influences of hemodynamic and electro cortical changes and the influence of stress on cognitive performance alterations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers (men or women)\n* Aged from 18 to 65\n* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)\n* Who accepted to take part in the study\n* Who have given their written stated consent\n* 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.\n\nSubjects will be staff member of the team or of other teams participating in the parabolic flight campaign\n\nExclusion Criteria:\n\n* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated\n* Persons with prior serious injuries to their head\n* Persons who take any medication or drugs influencing their central nervous system or cognitive performance\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT02805400', 'acronym': 'NeuroCog', 'briefTitle': 'Neurocognitive Performance During Space Flight. Validation of a Test Battery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Neurocognitive Performance During Space Flight. Validation of a Test Battery', 'orgStudyIdInfo': {'id': '2015-A00044-45'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Neurocognitive performance', 'description': '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.\n\nFor these methods only commercially available CE marked devices will be used.', 'interventionNames': ['Other: determination of cortical activity']}], 'interventions': [{'name': 'determination of cortical activity', 'type': 'OTHER', 'description': '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.\n\nFor these methods only commercially available CE marked devices will be used.', 'armGroupLabels': ['Neurocognitive performance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Caen CHU', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'centralContacts': [{'name': 'Pierre DP Denise, PhD', 'role': 'CONTACT', 'email': 'pierre.denise@unicaen.fr', 'phone': '02.31.06.81.32', 'phoneExt': '+33'}, {'name': 'Cathy GC Gaillard', 'role': 'CONTACT', 'email': 'gaillard-c@chu-caen.fr', 'phone': '02 31 06 53 49', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Pierre DP Denise, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU CAEN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novespace', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}