Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT02562560
Status:
TERMINATED
Last Update Posted:
2020-09-01
First Post:
2015-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuropsycholgy and Neuroimaging in Transient Global Amnesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020236', 'term': 'Amnesia, Transient Global'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000647', 'term': 'Amnesia'}, {'id': 'D008569', 'term': 'Memory Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}], 'ancestors': [{'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'DIAGNOSTIC'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'whyStopped': 'no more patient', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2015-09-28', 'studyFirstSubmitQcDate': '2015-09-28', 'lastUpdatePostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Episodic memory scores', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transient Global Amnesia (TGA)']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to establish a diagnosis in transient global amnesia (TGA) in assessing three episodic memory's abilities (mental simulation throught the future, and the past, the learning of personnal actions i-e the enactment effect). Secondary goal is to describe the neuronal substrates associated to the alteration of theses abilites in TGA."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All the participants\n\n * Minimum of 7 years of education\n * French native speaker\n* Healthy subjects : Non pathological Dementia rating scale score\n* Patients : Clinical diagnosis of TGA according to Hodges and Warlow's criterion\n\nExclusion Criteria:\n\n* Chronic neurological disease\n* Encephalitis\n* Endocrinal disease\n* Hepatic disease\n* Case history of head injury with loss of consciousness of more than one hour\n* Case history of stroke\n* Case history of cancer during the five last years except squamous cell carcinomas\n* Alcoholism or drug addiction\n* Major psychiatric disorders according the Diagnostic and Statistical Manual of -Mental Disorders"}, 'identificationModule': {'nctId': 'NCT02562560', 'acronym': '2NIA', 'briefTitle': 'Neuropsycholgy and Neuroimaging in Transient Global Amnesia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Neuropsycholgy and Neuroimaging in Transient Global Amnesia', 'orgStudyIdInfo': {'id': '2007-A00910-53'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TGA', 'interventionNames': ['Behavioral: Neuropsychological tests', 'Device: Cerebral imaging (MRI, PET-FDG)']}, {'type': 'EXPERIMENTAL', 'label': 'Controls', 'interventionNames': ['Behavioral: Neuropsychological tests', 'Device: Cerebral imaging (MRI, PET-FDG)']}], 'interventions': [{'name': 'Neuropsychological tests', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Controls', 'TGA']}, {'name': 'Cerebral imaging (MRI, PET-FDG)', 'type': 'DEVICE', 'armGroupLabels': ['Controls', 'TGA']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Fausto Viader, PUPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}