Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT03052712
Status:
TERMINATED
Last Update Posted:
2019-10-21
First Post:
2017-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D006816', 'term': 'Huntington Disease'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D002819', 'term': 'Chorea'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'whyStopped': 'not enough patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-09-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-17', 'studyFirstSubmitDate': '2017-02-07', 'studyFirstSubmitQcDate': '2017-02-10', 'lastUpdatePostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tests of social cognition (questionnaire)', 'timeFrame': '3 years', 'description': 'standardize and validate in French-speaking population a comprehensive battery of tests of social cognition'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Disorders of socio-emotional', 'Alzheimer', 'frontal temporal dementia', 'Parkinson', 'Huntington', 'traumatic brain injury', 'stroke', 'focal lesions'], 'conditions': ['Alzheimer Disease', 'Parkinson Disease', 'Frontal Dementia', 'Huntington Disease', 'Traumatic Brain Injury', 'Stroke']}, 'descriptionModule': {'briefSummary': "The role of disorders of socio-emotional processes in cerebral diseases such as Alzheimer's disease, frontal temporal dementia, Parkinson's disease, Huntington's disease, traumatic brain injury, stroke, focal lesions, has been recognized recently. Social cognition refers to a large group of emotional and cognitive abilities regulating inter-individuals relationships and it includes mainly theory of mind, emotional information processing and empathy. However, assessment of socio-emotional processes is still largely based on experimental tests that are not validated for clinical purpose. In addition their long duration of administration is not adapted to clinical examination. Finally these tests have not been standardized and normalized in French-speaking population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form (ICF)\n2. Male or female, aged 20 to 80 years inclusive at the time of signing ICF\n3. French-speaking\n4. reliable informant\n\n Controls:\n5. derived from the general population and consenting to participate in the study\n\n Patients:\n6. MMS\\>18\n7. Patients followed for mild or major neurocognitive disorder related to :\n\n * Alzheimer's disease\n * Frontotemporal lobar degeneration\n * Lewy bodies disease\n * Parkinson's disease\n * Huntington's disease\n * Progressive supranuclear palsy\n * traumatic brain injury\n * stroke or cerebral anoxia\n * mixed diseases\n * focal cerebral diseases\n\nExclusion Criteria:\n\n1. Illiteracy\n2. mental retardation\n3. visual or motor deficit preventing reading, drawing or writing (scores on the reading, drawing or sentence writing subtests of the MMSE = 0)\n4. hearing impairment interfering with understanding of instructions,\n5. history of brain disease, including head injury with loss of consciousness lasting \\> 15 minutes, stroke, coma or loss of consciousness lasting \\> 15 minutes, followed for sclerosis or other brain disease, brain radiation therapy, epilepsy currently requiring treatment\n6. history of psychiatric illness (schizophrenia or other psychosis) or ongoing psychiatric illness (major depressive disorder or other condition) currently requiring treatment or requiring a stay \\> 2 days in a psychiatry unit or anxiety requiring more than one medication at the present time\n7. alcoholism (mean alcohol consumption \\> 3 standard drinks/day or history of alcohol withdrawal)\n8. use of opiates or other illicit drugs during the previous 3 months or causing withdrawal syndrome\n9. ongoing antidepressant or antiepileptic treatment\n10. anxiolytic or hypnotic treatment initiated or increased during the previous month\n11. general anaesthesia during the previous 3 months\n12. history of heart surgery with cardiopulmonary bypass\n13. comorbidities affecting cognition (respiratory, renal, liver, heart failure…)\n14. women of childbearing potential (defined as pre-menopausal, less than 2 years postmenopausal, or not surgically sterile)\n15. persons placed under judicial protection\n\n Patients :\n16. contraindication to MRI\n\n Controls:\n17. deficit on MMSE \\<27"}, 'identificationModule': {'nctId': 'NCT03052712', 'acronym': 'GREFEXII', 'briefTitle': 'Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies', 'orgStudyIdInfo': {'id': 'PI2015_843_0031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients', 'description': 'battery of tests of social cognition', 'interventionNames': ['Behavioral: social cognition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'battery of tests of social cognition', 'interventionNames': ['Behavioral: social cognition']}], 'interventions': [{'name': 'social cognition', 'type': 'BEHAVIORAL', 'description': 'battery of tests of social cognition', 'armGroupLabels': ['Control', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'Olivier GODEFROY, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}