Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-01-31 @ 8:58 AM
Study NCT ID:
NCT06658392
Status:
COMPLETED
Last Update Posted:
2024-10-26
First Post:
2024-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Domain-general and Domain-specific Contributions to the Development of Numerical Cognition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2024-10-03', 'studyFirstSubmitQcDate': '2024-10-23', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BOLD response', 'timeFrame': 'BOLD response recorded during fMRI session', 'description': 'changes of BOLD response under different experimental conditions (non-symbolic arithmetic; symbolic arithmetic; inhibition; attention)'}, {'measure': 'BOLD response', 'timeFrame': 'during fMRI session', 'description': 'changes of BOLD response in experimental conditions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cognitive neuroscience', 'numerical cognition'], 'conditions': ['No Condition']}, 'descriptionModule': {'briefSummary': 'Exploring the non-symbolic and symbolic arithmetic competencies in two groups of children (5-, and 7-year-olds). Additionally, we explored the relationship with domain-general factors such as inhibition and attention. Recorded fMRI.', 'detailedDescription': 'Using T2\\*-weighted eip imaging, we measured BOLD response in two cohorts of healthy children while they were doing different cognitive tasks in the scanner. These tasks included solving non-symbolic (i.e. sets of elements) and symbolic (i.e. Arabic digits) addition and subtraction problems, a color control task, an attentional task measuring different facets of spatial attention, and a task measuring inhibition. We also recorded a high-resolution anatomical scan of the brain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* school enrollment\n* French as mother tongue\n* right-handed\n* normal medical, neurological and neuroradiological examinations - parents affiliated to a social security scheme\n\nExclusion Criteria:\n\n* not within age range\n* monocygotic twins\n* \\- contraindications to an MRI examination (neurosensory stimulator or implantable defibrillator, cochlear implants, ferromagnetic ocular or cerebral foreign bodies close to nerve structures, metal prostheses, patient agitation: uncooperative or agitated patients, claustrophobic subjects, ventriculoperitoneal neurosurgical shunt valves, dental apparatus, etc.).\n* sudden onset of cognitive problems that could indicate a stroke; a history of head trauma with loss of consciousness lasting more than 1 hour, or encephalitis; - a chronic neurological, psychiatric, endocrine, hepatic or infectious condition\n* a history of major illness (diabetes, chronic lung disease, severe cardiac, metabolic, hematological, endocrinological or immunological disorders, cancer); - medication likely to interfere with brain imaging measurements\n* color blindness or uncorrected visual disorders\n* inability to take part in the study for geographical or psychiatric reasons\n* presence of pervasive developmental and/or acquisition disorders identified by parents or legal guardians and/or teachers\n* cerebral palsy\n* impaired fine motor skills\n* parents or legal guardians not affiliated to a social security scheme\n* unaccompanied by parent(s) or legal guardian(s) during visits.\n* tattoo not compatible with MRI\n* children and parents under legal protection'}, 'identificationModule': {'nctId': 'NCT06658392', 'acronym': 'CFDDCN', 'briefTitle': 'Domain-general and Domain-specific Contributions to the Development of Numerical Cognition', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier St Anne'}, 'officialTitle': 'Domain-general and Domain-specific Contributions to the Development of Numerical Cognition', 'orgStudyIdInfo': {'id': 'D20-P011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'arithmetic', 'description': 'exploring neurocognitive mechanisms underlying development of arithmetic competencies in healthy children.', 'interventionNames': ['Other: cognitive tasks']}], 'interventions': [{'name': 'cognitive tasks', 'type': 'OTHER', 'description': 'no intervention in a medical sense, only observing changes of BOLD signal during different experimental conditions in cognitive tasks (arithmetic, attention, inhibition)', 'armGroupLabels': ['arithmetic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Centre Hospitalier Sainte-Anne', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Catherine OPPENHEIM, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Promotor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier St Anne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}