Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-04 @ 5:27 PM
Study NCT ID:
NCT03919357
Status:
COMPLETED
Last Update Posted:
2021-05-20
First Post:
2019-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using a New Calibrated Tool in Specific Language and Learning Disorders : the BMTi
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067559', 'term': 'Specific Learning Disorder'}, {'id': 'D002658', 'term': 'Developmental Disabilities'}], 'ancestors': [{'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 229}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-19', 'studyFirstSubmitDate': '2019-04-04', 'studyFirstSubmitQcDate': '2019-04-15', 'lastUpdatePostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of BMT-i (modular computerized test battery)', 'timeFrame': '3 months', 'description': 'Calculation of the sensitivity of the BMT-i compared to the reference balance sheets'}, {'measure': 'Specificity of BMT-i', 'timeFrame': '3 months', 'description': 'Calculation of the specificity of the BMT-i compared to the reference balance sheets'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and specificity of the BMT-i by type of complaint', 'timeFrame': '3 months', 'description': 'Calculation of the sensitivity and specificity of the BMT-i compared to the reference balance in each type of complaint (oral language, learning, graphics and attention)'}, {'measure': 'Kappa de Cohen test between BMTi assessments and the reference assessments', 'timeFrame': '3 months', 'description': 'Assessment of the concordance between the BMTi assessments and the baseline assessments'}, {'measure': 'Concordance between investigators evaluations and reviewers evaluations', 'timeFrame': '3 months', 'description': 'Evaluation of the concordance between the BMTi evaluations rated by the investigators and the reviewers'}, {'measure': 'Curves ROC (Receiver operating characteristic)', 'timeFrame': '3 months', 'description': 'Receiver operating characteristic (ROC) curves to validate selected BMT-i diagnostic thresholds'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Learning Disorders, Specific', 'Developmental Disability']}, 'descriptionModule': {'briefSummary': 'The group of experts at HAS has defined the places of first and second-line workers in specific disorders of development and learning, as defined in the international diagnostic classifications International Classification of Diseases (CIM) CIM 11 and Diagnostic and Statistical Manual of Mental Disorders (DSM) DSM 5. The referral to a second-level structure, a multidisciplinary structure in charge of carrying out the different cognitive assessments, requires a preliminary evaluation.\n\nThis orientation is based on a medical consultation, carried out by a doctor specialized in the field, with an exploration tool adapted to the different fields concerned.\n\nThe BMTi, a battery of third-generation tests (after the Rapid battery of evaluation of the cognitive functions (BREV) and then the Evaluation of cognitive functions and learning of the child (EDA)) will enable the doctor, from 2018, to carry out this orientation in a relevant way in response to children with a complaint about neurodevelopment and learning. .\n\nThe research project aims to validate this hypothesis, by comparing the diagnoses posed in a conventional way with the various multidisciplinary assessments, with the results of the transfer of all or part of the subtests of the BMTi by a doctor of second resort.', 'detailedDescription': 'The group of experts at High Authority of Health (HAS) has defined the places of first and second-line workers in specific disorders of development and learning, as defined in the international diagnostic classifications CIM 11 and DSM 5. The referral to a second-level structure, a multidisciplinary structure in charge of carrying out the different cognitive assessments, requires a preliminary evaluation.\n\nThis orientation is based on a medical consultation, carried out by a doctor specialized in the field, with an exploration tool adapted to the different fields concerned.\n\nThe BMTi, a battery of third-generation tests (after the BREV and then the EDA) will enable the doctor, from 2018, to carry out this orientation in a relevant way in response to children with a complaint about neurodevelopment and learning. .\n\nThe research project aims to validate this hypothesis, by comparing the diagnoses posed in a conventional way with the various multidisciplinary assessments, with the results of the transfer of all or part of the subtests of the BMTi by a doctor of second resort.\n\nThis research project finds its place in a more global approach for a complete application of the recommendations of the group of experts of the High Authority of Health with:\n\n* the systematic evaluation of educational prevention strategies by intensive training in small groups of children with similar needs, in schools,\n* the evaluation of the role of the primary care physician in the prescription of the initial investigation report in the face of a simple reading, writing or numeracy disorder (research project with letter of intent filed in the framework of the call for tenders 38/5000 general direction of the offer of care (DGOS) PREPS 2018),\n* the current project to validate referral tools to second-level appraisals,\n* an evaluation project of the financing modalities filed under the regional health agency "Occitanie" in the framework of the call for tenders of article 51,\n* the introduction of training courses for the first and second-line tools for ambulatory doctors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children between 5 and 13 years old with a complex developmental and learning disorder', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child aged 5 to 13\n* Complex complaint affecting one of the different areas of development and learning\n* Affiliation to a social security scheme\n\nExclusion Criteria:\n\n* Diagnosis of intellectual development disorder of autism spectrum disorder and suspect or confirm\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT03919357', 'acronym': 'ValidBMTI', 'briefTitle': 'Using a New Calibrated Tool in Specific Language and Learning Disorders : the BMTi', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Assessment of the Diagnostic Approach to Specific Language Disorders and Learning Using a New Calibrated Tool: the Modular Battery Tests Computerized (BMTi)', 'orgStudyIdInfo': {'id': 'ValidBMTI2018'}, 'secondaryIdInfos': [{'id': '2018-A01870-55', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Verbal', 'description': 'Passing of a specialized questionnaire on verbal disorders', 'interventionNames': ['Behavioral: BMT-i']}, {'label': 'Non-verbal', 'description': 'Passing of a specialized questionnaire on non verbal disorders', 'interventionNames': ['Behavioral: BMT-i']}, {'label': 'Attention', 'description': 'Passing of a specialized questionnaire on attention disorders', 'interventionNames': ['Behavioral: BMT-i']}, {'label': 'Complaint about learning', 'description': 'Passing of a specialized questionnaire on learning disorders', 'interventionNames': ['Behavioral: BMT-i']}], 'interventions': [{'name': 'BMT-i', 'type': 'BEHAVIORAL', 'description': 'Passing the BMT-i test', 'armGroupLabels': ['Attention', 'Complaint about learning', 'Non-verbal', 'Verbal']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Besançon', 'country': 'France', 'facility': 'Cabinet du Dr Vurpillat-Almanza', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Chamalières', 'country': 'France', 'facility': 'Cabinet du Dr Piollet', 'geoPoint': {'lat': 45.77364, 'lon': 3.06703}}, {'zip': '73000', 'city': 'Chambéry', 'country': 'France', 'facility': 'Cabinet du Dr Gelbert', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'city': 'Le Chesnay', 'country': 'France', 'facility': 'CH Versailles - André Mignot', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Centre Médical Pédiatrique Flammarion', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital Saint Eloi - Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '45000', 'city': 'Orléans', 'country': 'France', 'facility': 'Cabinet du Dr Kochert', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Centre Paris Santé Réussite', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '92800', 'city': 'Puteaux', 'country': 'France', 'facility': 'Cabinet du Dr Cahn-Sellem', 'geoPoint': {'lat': 48.88341, 'lon': 2.23894}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint-Denis', 'country': 'France', 'facility': 'Cabinet du Dr Reynaud', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Cabinet du Dr Willig', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Trélazé', 'country': 'France', 'facility': 'Cabinet du Dr Pineau', 'geoPoint': {'lat': 47.44629, 'lon': -0.46652}}, {'city': 'Verrières-le-Buisson', 'country': 'France', 'facility': 'Cabinet du Dr Lubelski', 'geoPoint': {'lat': 48.74565, 'lon': 2.26796}}, {'city': 'Villeneuve-lès-Avignon', 'country': 'France', 'facility': 'Cabinet du Dr Werner', 'geoPoint': {'lat': 43.96773, 'lon': 4.79258}}, {'zip': '97129', 'city': 'Le Lamentin', 'country': 'Martinique', 'facility': 'Cabinet du Dr Dulorme', 'geoPoint': {'lat': 14.61341, 'lon': -60.99964}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'collaborators': [{'name': "Association pour la recherche des troubles de l'apprentissage", 'class': 'UNKNOWN'}, {'name': 'Orthoédition', 'class': 'UNKNOWN'}, {'name': 'Association Française de Pédiatrie Ambulatoire- AFPA', 'class': 'UNKNOWN'}, {'name': "Association pour l'Etude du Développement de l'Enfant", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}