Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-05 @ 1:55 AM
Study NCT ID:
NCT02189460
Status:
TERMINATED
Last Update Posted:
2018-10-12
First Post:
2014-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Normal Aging on Language Processing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Not enough subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2014-07-03', 'studyFirstSubmitQcDate': '2014-07-10', 'lastUpdatePostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Oxygen Level Dependent functional MRI', 'timeFrame': 'There will be a unique MRI measurement for each participant. Group analyses presentation after 1 year.', 'description': 'We use 3 functional tasks using block paradigm: Object naming, Verbal generation and semantic judgment, to elicit BOLD response using fMRI in order to compare functional activation patterns between subjects.\n\nWe also use hypercapnic challenge to elicit BOLD response in order to obtain Cerebral Vascular Reactivity properties of subjects.'}, {'measure': 'Anatomical MRI', 'timeFrame': 'There will be a unique MRI measurement for each participant. Group analyses presentation after 1 year.', 'description': 'We use Voxel Based Morphometry to compare cortical volume (grey matter) between subjects.\n\nWe also use tractography Diffusion Tensor Imaging to compare white matter properties between subjects.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cognition'], 'conditions': ['Cognition']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand the effect of age on language abilities. The investigators aim at investigating the cerebral modifications that take place in normal aging, at the functional an anatomical level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '60 healthy adults will participate to the study. There will be 3 age groups: 30-50, 50-70, \\> 70 years. Ech group will contain 20 volunteers.\n\nThe volunteers are recruited by means of ads on Laboratory websites and Universities.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 30 years and above\n* Right handed\n* French native speakers\n* Affiliation to French social security (Sécurité Sociale)\n* Medical interview\n* Consent form signed\n\nExclusion Criteria:\n\n* Cerebral or respiratory pathologies\n* Any MRI contrindication'}, 'identificationModule': {'nctId': 'NCT02189460', 'acronym': 'SEMVIE', 'briefTitle': 'Effect of Normal Aging on Language Processing', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Cognitive Mechanisms and Cerebral Substrate of Naming Impairment During Aging. Behavior and Neuroimaging Approaches.', 'orgStudyIdInfo': {'id': '2014-AZ00569-38'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy adults', 'description': '20 young adults aged between 30 and 50 years old. 20 middle aged adults aged between 50 and 70 years old. 20 older adults of 70 years old and more.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'IRMaGe facility', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Alexandre Krainik, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neuroradiology department, Grenoble Hospital, INSERM, Grenoble University.'}, {'name': 'Monica Baciu, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Laboratory of Psychology and NeuroCognition, CNRS, Grenoble University.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}