Ignite Creation Date:
2025-12-24 @ 12:45 PM
Ignite Modification Date:
2026-02-20 @ 6:34 PM
Study NCT ID:
NCT03972761
Status:
UNKNOWN
Last Update Posted:
2019-06-04
First Post:
2019-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive Remediation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-09-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2021-09-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-31', 'studyFirstSubmitDate': '2019-05-31', 'studyFirstSubmitQcDate': '2019-05-31', 'lastUpdatePostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Activation of cortical areas', 'timeFrame': '24 months', 'description': 'Hyper activation on the Magnetic Resonance Imaging (MRI) associated with working memory'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature Childbirth']}, 'descriptionModule': {'briefSummary': 'Infantile brain plasticity is still a poorly known phenomenon. However, neuropsychological disorders and behavioral deficits are common disorders that can have serious consequences for school enrollment, family and social adjustment, as well as repercussions on future adult lives.\n\nIn addition, generally very premature infants (TGP) have identifiable executive function disorders (EF), particularly those involving attentional processes such as working memory (WM).\n\nThe main objective of the study is to evaluate the effects of cognitive remediation (CR) strategies on the brain plasticity of the cortical areas involved in the management of WM in school-aged TGP children (8 years).\n\nThe secondary objective of the study is to evaluate the action of CR on the development of cortical areas concerned\n\nIt is a monocentric, prospective and comparative study of the exposed type (to cognitive remediation) - unexposed. Recruitment and data collection are carried out prospectively, in connection with the original study (EPIREMED). Included patients will be explored by Magnetic Resonance Imaging (MRI) 3 resting state Tesla.\n\nThe main hypothesis is that CR strategies have a beneficial effect on the cognitive processing of visual-spatial executive functions, but also on the cortical areas involved in brain plasticity in general (indirect benefits); not to mention the psychological benefits ad hoc to such studies (self-esteem, increased concentration, new stress management strategies put in place).\n\nThe ultimate objective of this study is to better understand the mechanisms of cerebral plasticity concerning higher executive functions. Moreover, this study should make it possible to confirm the improvement of the overall fate of the child by better understanding the neuropsychological and anatomical origins of his disorders. Interventions taking into account the environment of the very premature baby are necessary because it is closely linked to the developmental future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children born between 24 and 34 weeks of amenorrhea and living in the Provence region\n* Possessing an intelligence quotient (IQ) greater than 70\n\nExclusion Criteria:\n\n* Child not understanding French\n* Child who did not have all the interventions in the EPIREMED study'}, 'identificationModule': {'nctId': 'NCT03972761', 'acronym': 'EPIREM', 'briefTitle': 'Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive Remediation', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive', 'orgStudyIdInfo': {'id': '2019-07'}, 'secondaryIdInfos': [{'id': '2019-A00829-48', 'type': 'OTHER', 'domain': 'ID RCB'}, {'id': 'RCAPHM19_0023', 'type': 'OTHER', 'domain': 'Secondary AP-HM number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group exposed to cognitive remediation', 'description': 'Computerized cognitive remediation program. Program performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794)', 'interventionNames': ['Device: Magnetic Resonance Imaging (MRI) 3 tesla']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group not exposed to cognitive remediation', 'description': 'Standard remediation performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794)', 'interventionNames': ['Device: Magnetic Resonance Imaging (MRI) 3 tesla']}], 'interventions': [{'name': 'Magnetic Resonance Imaging (MRI) 3 tesla', 'type': 'DEVICE', 'description': 'Functional neuroimaging objectifies the activation of specific areas of the brain', 'armGroupLabels': ['Group exposed to cognitive remediation', 'Group not exposed to cognitive remediation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'Barthélémy TOSELLO, PH', 'role': 'CONTACT', 'email': 'barthelemy.tosello@ap-hm.fr', 'phone': '491968300', 'phoneExt': '+33'}, {'name': 'Barthélémy TOSELLO, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assistance Publique Hôpitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Barthélémy TOSELLO, PH', 'role': 'CONTACT', 'email': 'barthelemy.tosello@ap-hm.fr', 'phone': '491968300', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Jean-Olivier ARNAUD, Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hôpitaux de Marseille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}