[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484333":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":60,"centralContacts":64,"locations":74,"responsibleParty":86,"collaborators":10,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":10,"studyType":103,"phases":10,"briefSummary":104,"conditions":105,"keywords":110,"overallStatus":114,"whyStopped":10,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Etablissement Public de Santé Barthélemy Durand","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"ASD group",null,"Participants aged from 3 years to 4 years and half at inclusion will be clinically evaluated with standardized scales and tests and will performed an EEG-HR recording while listening to successive soundtracks at several times.",[13,14,15,16,17,18],"Device: EEG-HR","Diagnostic Test: ADI-R","Diagnostic Test: ADOS-2","Diagnostic Test: IDE","Diagnostic Test: MSEL","Diagnostic Test: Dunn",{"label":20,"type":10,"description":21,"interventionNames":22},"Control group","Participants aged from 3 years to 4 years and half at inclusion will be clinically evaluated with standardized scales and tests and will performed an EEG-HR recording while listening to successive soundtracks in inclusion visit.",[13,14,15,16],[24,29,36,42,50,56],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"DEVICE","EEG-HR","Passation EEG-HR",[9,20],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DIAGNOSTIC_TEST","ADI-R","Passation of ADI-R scale",[9,20],[35],"AUTISM DIAGNOSTIC INTERVIEW-REVISED",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"ADOS-2","Passation of ADOS-2 scale",[9,20],[41],"AUTISM DIAGNOSTIC OBSERVATION SCHEDULE 2",{"type":30,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"IDE","Passation of IDE scale",[9,20],[47,48,49],"Inventaire du Développement de l'Enfant","CDI","Child Development Inventory",{"type":30,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"MSEL","Passation of MSEL scale",[9],[55],"Mullen Scales of Early Learning",{"type":30,"name":57,"description":58,"armGroupLabels":59,"otherNames":10},"Dunn","Passation of Dunn scale",[9],[61],{"name":62,"affiliation":5,"role":63},"Mariette Vinurel","PRINCIPAL_INVESTIGATOR",[65,70],{"name":66,"role":67,"phone":68,"phoneExt":10,"email":69},"Adelaide Aduayi","CONTACT","+33 1 75 02 16 81","adelaide.aduayi@eps-etampes.fr",{"name":71,"role":67,"phone":72,"phoneExt":10,"email":73},"Morgane Da Silva Hennequin","+33 1 82 26 81 08","morgane.dasilvahennequin@eps-etampes.fr",[75],{"facility":5,"status":10,"city":76,"state":10,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":10},"Étampes","91150","France","FR",{"type":81,"coordinates":82},"Point",[83,84],2.16233,48.43507,{"lat":84,"lon":83},{"type":87,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100484333","hr-eeg-contribution-in-prognostic-evaluation-of-language-development-in-children-with-asd-100484333",false,"NCT05586672","HR-EEG Contribution in Prognostic Evaluation of Language Development in Children With ASD","High Resolution Electroencephalogram Contribution in Prognostic Evaluation of Language Development in Children With Autism Spectrum Disorder","EE-TSA-LANG","Inclusion Criteria:\n\nFor all participants\n\n* Child aged from 3 years to 4 years and half at inclusion.\n* Information delivered and no parental objection for study participation.\n\nFor ASD group\n\n* Diagnosis of ASD according to DSM-V criteria.\n* Expressive language level \\\u003C 27 months regarding on IDE scale.\n\nFor Control group - Matched on age (at +\u002F- 3 months) and gender to ASD group participants.\n\nExclusion Criteria:\n\nFor all participants\n\n* Any illness or treatment that could significantly alter EEG-HR recording (epilepsy, anti-epileptic treatment, psychotropic drugs...).\n* Major hearing or vision disorders.\n\nFor ASD group\n\n\\- Severe and characterised neurological pathology other than ASD\n\nFor Control group\n\n* Characterised neurological or psychiatric pathology.\n* Characteristic language delay.",true,"ALL","3 Years","4 Years",{"count":101,"type":102},120,"ESTIMATED","OBSERVATIONAL","The goal of this prospective observational multicentric cohort study is to evaluate the clinical prognostic value of the speech tracking score of language development in children with ASD aged from 3 years to 4 years and half at inclusion.\n\nParticipants will followed during 4 years with an annual visit. During these visits, each participant will be clinically evaluated (scales and tests) and performed an EEG-HR recording. Two groups will be formed, one with children diagnosed with ASD with language delay, and a control group composed of non-ASD children without language delay, matched on age and gender with the ASD group.",[106,107,108,109],"Autism Spectrum Disorder","Language Development","Neurocognitive Disorders","Child Language",[111,112,106,113],"High Resolution electroencephalogram","Child","Language","NOT_YET_RECRUITING","2022-10-15",{"date":117,"type":118},"2022-10-19","ACTUAL",{"date":120,"type":102},"2023-01-02",{"date":122,"type":102},"2028-06-30",{"name":5,"class":6},1]