Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT03513133
Status:
UNKNOWN
Last Update Posted:
2018-05-03
First Post:
2018-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rehabilitation of Working Memory and Brain Plasticity After Traumatic Brain Injury: Plastim-MDTC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'a group of 10 patients with severe TBI will receive 3-month rehabilitation of working memory and will be compared to a group of 10 healthy controls'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2018-02-19', 'studyFirstSubmitQcDate': '2018-04-30', 'lastUpdatePostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'working memory questionnaire', 'timeFrame': 'change from baseline to 3 months', 'description': 'It is a self-assessment questionnaire comprising 30 questions scored on a five-point Likert scale, ranging from 0 ("no problem at all") to 4 ("very severe problem in everyday life"). The total score will be used.'}], 'secondaryOutcomes': [{'measure': 'working memory testing', 'timeFrame': 'change from baseline to 3 months', 'description': 'neuropsychological assessment of working memory'}, {'measure': 'neuro-imaging changes', 'timeFrame': 'change from baseline to 3 months', 'description': 'multimodal 3T MRI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['working memory', 'cognitive rehabilitation', 'functional neuroimaging'], 'conditions': ['Traumatic Brain Injury', 'Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '16286329', 'type': 'BACKGROUND', 'citation': 'Vallat C, Azouvi P, Hardisson H, Meffert R, Tessier C, Pradat-Diehl P. Rehabilitation of verbal working memory after left hemisphere stroke. Brain Inj. 2005 Dec;19(13):1157-64. doi: 10.1080/02699050500110595.'}, {'pmid': '22537095', 'type': 'BACKGROUND', 'citation': 'Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. The Working Memory Questionnaire: a scale to assess everyday life problems related to deficits of working memory in brain injured patients. Neuropsychol Rehabil. 2012;22(4):634-49. doi: 10.1080/09602011.2012.681110. Epub 2012 Apr 27.'}, {'pmid': '19484632', 'type': 'BACKGROUND', 'citation': 'Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. Rehabilitation of the central executive of working memory after severe traumatic brain injury: two single-case studies. Brain Inj. 2009 Jun;23(6):585-94. doi: 10.1080/02699050902970711.'}, {'pmid': '24552571', 'type': 'BACKGROUND', 'citation': 'Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. Modularity in rehabilitation of working memory: a single-case study. Neuropsychol Rehabil. 2014;24(2):220-37. doi: 10.1080/09602011.2014.881294. Epub 2014 Feb 19.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the brain correlates, as assessed with multimodal MRI, of working memory training in patients with severe traumatic brain injury (TBI)', 'detailedDescription': 'This is a pilot feasibility study. Patients with subacute/chronic (\\> 6 months) severe TBI will be included if they suffer from a deficit in working memory. They will receive a specific hierarchical training of working memory (3 sessions per week during three months), according to a previously described methodology.\n\nA multimodal MRI will be performed at neuroSpin center (CEA, Orsay, France) before and after cognitive training, including: structural imaging (T1, FLAIR and diffusion tensor imaging, DTI); functional connectivity at rest; and functional activation during a working memory task (n-back).\n\nBehavioral and imaging changes after training will be analysed individually and compared to a group of healthy controls matched for age, gender and education.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* moderate to severe traumatic brain injury\n* 6 months or more after the injury\n* working memory deficit on cognitive testing\n\nExclusion Criteria:\n\n* previous neurological or psychiatric condition\n* severe behavioral troubles\n* contra-indication to MRI\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT03513133', 'acronym': 'Plastim-MDTC', 'briefTitle': 'Rehabilitation of Working Memory and Brain Plasticity After Traumatic Brain Injury: Plastim-MDTC', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Investigation Clinique et Technologique 805"}, 'officialTitle': 'Rehabilitation of Working Memory After Traumatic Brain Injury: Pilot Study of Brain Plasticity in Multimodal Advanced MRI', 'orgStudyIdInfo': {'id': '2016-A00678-43'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'working memory training', 'description': 'Patients with severe TBI will receive a hierarchical training of working memory according to a previously described methodology. They will receive 3 sessions per week during three months (each session=1 h approximately)', 'interventionNames': ['Behavioral: working memory training']}], 'interventions': [{'name': 'working memory training', 'type': 'BEHAVIORAL', 'description': "Hierarchical cognitive training of the different components of working memory according to Baddeley model; 15 tasks are used addressing: the phonological loop (8 tasks), the visuospatial sketchpad (4 tasks) and the central executive 3 tasks). Task are given in a hierarchical order, according to each individual patient's deficits and improvement.", 'armGroupLabels': ['working memory training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe AZOUVI, MD-PhD', 'role': 'CONTACT', 'email': 'philippe.azouvi@aphp.fr', 'phone': '0033 147107074'}, {'name': 'Erica VLACHOS, CRA', 'role': 'CONTACT', 'email': 'erica.vlachos@aphp.fr', 'phone': '0033 147104472'}], 'facility': 'APHP Hôpital Raymond Poincaré', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'centralContacts': [{'name': 'Philippe AZOUVI, MD-PhD', 'role': 'CONTACT', 'email': 'philippe.azouvi@aphp.fr', 'phone': '0033 147107074'}, {'name': 'Erica VLACHOS, CRA', 'role': 'CONTACT', 'email': 'erica.vlachos@aphp.fr', 'phone': '0033 147104472'}], 'overallOfficials': [{'name': 'Philippe AZOUVI, MD-PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'APHP Hôpital Raymond Poincaré'}, {'name': 'Lucie HERTZ PANNIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neurospin- CEA'}, {'name': 'Eric BRUNET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital André Mignot'}, {'name': 'Claire Vallat-Azouvi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Paris 8'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre d'Investigation Clinique et Technologique 805", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}