Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-01-13 @ 10:25 AM
Study NCT ID:
NCT02333006
Status:
UNKNOWN
Last Update Posted:
2018-02-01
First Post:
2014-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010468', 'term': 'Perceptual 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-31', 'studyFirstSubmitDate': '2014-12-24', 'studyFirstSubmitQcDate': '2015-01-06', 'lastUpdatePostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anosognosia score', 'timeFrame': '1h30', 'description': 'Questionaire about anosognosia'}], 'secondaryOutcomes': [{'measure': 'Neuropsychological score', 'timeFrame': '1h', 'description': 'Neuropsychological tests'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anosognosia'], 'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'This study is conducted over 18 months. The main objective of this study is to test and compare the relevance and reliability of different tools for measuring the anosognosia.\n\nSecondary objectives are :\n\n* identify the relevant test who are able to evaluate more specially the cognitive processes involved in anosognosia\n* explore the links between the anosognosia manifestations and the psychological manifestations', 'detailedDescription': "This experimental protocol is proposed to 40 patients who have a moderate or severe traumatic brain injury. All of this protocol is 2 hours, tasks are administered in the order named.\n\nTo measure anosognosia, this protocol is to administer 4 questionnaires used in clinical routine who have proposed to patients and their therapist and relative who know them well. The chosen measure is the difference between the results of the patient and that of the therapist or relative. Others evaluations are administrated to question the beliefs capacity during 2 certainty of judgment tasks replicated or adapted articles from the literature (tasks of guessing and task of judgments facts).\n\nThe patients are also evaluated through several executive tasks (who come from battery of tests called 'Groupe de Reflexion sur l'évaluation des fonctions exécutives') and global cognitive efficiency tasks from the Wechsler Adult Intelligence Scale (involving non-verbal reasoning, psychomotor speed and general knowledge). These different tests measure the capacity of inhibition, mental flexibility, planning and information generation.\n\nAt last, mood and coping strategy questionnaires are proposed to patients for complete this protocol.\n\nThis protocol are also administered to 40 volunteers who have not had traumatic brain injury to monitor standards in general population (because all these tasks are not systematically standardized)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with a moderate or severe traumatic brain injury occurred at least 3 months ago (Glasgow ≤ 12 or duration of post-traumatic amnesia \\> 1 week)\n* patients ≥ 18 years old and who have signed a letter of information\n\nExclusion Criteria :\n\n* motor, sensitive and phasic disorders who are not allowing the test passation\n* neurological or psychiatric antecedents\n* patients who refused to participate in the study\n* non affiliation to a social security scheme\n* patients under guardianship or trusteeship'}, 'identificationModule': {'nctId': 'NCT02333006', 'acronym': 'ANOSOGNOSIA', 'briefTitle': 'Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Investigation Clinique et Technologique 805"}, 'officialTitle': 'Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe', 'orgStudyIdInfo': {'id': '2014-A00110-47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Traumatic brain injury questionnaires', 'description': 'Traumatic brain injury patients with anosognosia will answer to quetionnaires about Anosognosia compare to the answer of participant without neurological deficits', 'interventionNames': ['Other: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Traumatic brain injury patients and participant without neurological deficits will answer to questionnaires about Anosognosia', 'armGroupLabels': ['Traumatic brain injury questionnaires']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'PHILIPPE AZOUVI, MDPHD', 'role': 'CONTACT', 'email': 'philippe.azouvi@rpc.aphp.fr', 'phone': '0033147107074'}, {'name': 'SANDRA POTTIER, CRA', 'role': 'CONTACT', 'email': 'sandra.pottier@rpc.aphp.fr', 'phone': '0033147104469'}], 'facility': 'Hopital Raymond Poincare', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'centralContacts': [{'name': 'PHILIPPE AZOUVI, MDPHP', 'role': 'CONTACT', 'email': 'philippe.azouvi@rpc.aphp.fr', 'phone': '00331 47 10 70 74'}], 'overallOfficials': [{'name': 'EMILIE DROMER, Psychologue', 'role': 'STUDY_CHAIR', 'affiliation': 'Raymond Poincaré Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre d'Investigation Clinique et Technologique 805", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MDPHD', 'investigatorFullName': 'AZOUVI', 'investigatorAffiliation': "Centre d'Investigation Clinique et Technologique 805"}}}}