[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100400547":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":64,"centralContacts":68,"locations":74,"responsibleParty":91,"collaborators":38,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":38,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":77,"whyStopped":38,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8,18,24,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Severe\u002Fprofoundly deaf children 10-24 months old","EXPERIMENTAL","The cohort 1 includes patients aged 10-24 months old about to be implanted",[13,14,15,16,17],"Device: Near InfraRed Spectroscopy (fNIRS)","Behavioral: Passive perceptual stimulation","Behavioral: Task A not B","Behavioral: VSWMT task","Behavioral: The sensory room",{"label":19,"type":10,"description":20,"interventionNames":21},"Severe\u002Fprofoundly deaf children 3-7 years old","The cohort 2 includes 3-7 years old cochlear implanted patients (implanted before 24 months of age)",[13,14,16,22,23],"Behavioral: Perceptual Go-No-Go","Behavioral: Verbal memory task",{"label":25,"type":6,"description":26,"interventionNames":27},"Normally hearing children 10-24 months old","The cohort 1 includes patients aged 10-24 months matched in age and sex with normally hearing children",[13,14,15,16,17],{"label":29,"type":6,"description":30,"interventionNames":31},"Normally hearing children 3-7 years old","The cohort 2 includes 3-7 years old matched in sex and age with cochlear implanted patients",[13,14,16,22,23],[33,39,44,48,52,56,60],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DEVICE","Near InfraRed Spectroscopy (fNIRS)","Functional neuroimaging examination by fNIRS at each follow-up visit for all children of both cohorts: this non-invasive imaging technique involves the installation of a cap carrying electrodes to collect brain activity on the surface of the scalp , during stimulation. It is very insensitive to movement and therefore represents a method particularly suitable for its use in children. In addition, this technique is compatible with the cochlear implant. It will be used during 6 tasks adapted to each cohort",[25,29,9,19],null,{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":38},"BEHAVIORAL","Passive perceptual stimulation","Passive perceptual stimulation: For this passive task the child is on his parents' lap in front of a screen. He will see images, hear everyday noises and watch small videos. Duration 8-10 minutes.",[25,29,9,19],{"type":40,"name":45,"description":46,"armGroupLabels":47,"otherNames":38},"Task A not B","Task A not B: the child will play with an adult who will hide an object under a cloth several times. The child will have to find the hidden object. Duration 10 minutes maximum",[25,9],{"type":40,"name":49,"description":50,"armGroupLabels":51,"otherNames":38},"VSWMT task","VSWMT task: the child will be on the parents' lap in front of a screen and will watch a monkey hiding bananas in the trees several times. Duration of 10 minutes maximum.",[25,29,9,19],{"type":40,"name":53,"description":54,"armGroupLabels":55,"otherNames":38},"Perceptual Go-No-Go","Perceptual Go-No-Go: This perceptual task consists in the discrimination of images (faces) and sounds (words) through 3 conditions (auditory, visual and visuo-auditory) presented independently of each other and lasts 15 to 20 minutes in total. It is presented by means of a computer",[29,19],{"type":40,"name":57,"description":58,"armGroupLabels":59,"otherNames":38},"Verbal memory task","Verbal memory task :the child will be presented with 5 lists of 5 words which he will have to restore after a predefined delay of a few seconds. Its duration does not exceed 10 minutes.",[29,19],{"type":40,"name":61,"description":62,"armGroupLabels":63,"otherNames":38},"The sensory room","The sensory room: the child will sit in the middle of a carpet and play with the adult. He will hear everyday noises and see light effects. Duration 8-10 minutes",[25,9],[65],{"name":66,"affiliation":5,"role":67},"Yohan GALLOIS, MD","PRINCIPAL_INVESTIGATOR",[69],{"name":66,"role":70,"phone":71,"phoneExt":72,"email":73},"CONTACT","5 61 77 85 97","+33","gallois.y@chu-toulouse.fr",[75],{"facility":76,"status":77,"city":78,"state":38,"zip":38,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Gallois Yohan","RECRUITING","Toulouse","France","FR",{"type":82,"coordinates":83},"Point",[84,85],1.44367,43.60426,{"lat":85,"lon":84},[88],{"name":89,"role":70,"phone":90,"phoneExt":72,"email":73},"Yoahn Gallois","5 61 73 73 71",{"type":92,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100400547","restauration-of-the-auditory-and-cognitive-functions-in-cochlear-implanted-deaf-children-in-fnirs-100400547",false,"NCT04495660","Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in FNIRS","HearCog","Inclusion Criteria:\n\n* Inclusion criteria:\n\nCohort 1 :\n\n* 10-24 months old children will be included.\n* All participants have to be affiliated to the social health security system and parental consent is obligatory.\n* All congenitally deaf patients will have a severe to profound hearing loss and about to be fitted with a cochlear implant.\n* Normally hearing counterparts shall have normal hearing as evidenced by acoustical otoemissions (AOE) in both ears.\n\nCohort 2 :\n\n* 3-7 years old children will be included.\n* All participants have to be affiliated to the social health security system and parental consent is obligatory.\n* All congenitally deaf patients will have a cochlear implant, and they will have been implanted before 2 years of age.\n* Normally hearing counterparts shall have normal hearing as evidenced by acoustical otoemissions (AOE) in both ears.\n\nExclusion Criteria:\n\n* Exclusion criteria include psycho-neurological diseases, other sensorineural or motor deficiency, familial bilingualism, medications affecting vigilance and child whose both parents benefit from a legal protection measure","ALL","10 Months","7 Years",{"count":104,"type":105},80,"ESTIMATED","INTERVENTIONAL",[108],"NA","The principal aim of this study is to evaluate the cortical developement of perceptual skills and executive functions over time, in children with cochlear implants aged 10-24 months and 3-7 years compared with normally hearing subjects (NHS). To do this, the investigator will use functional Near InfraRed Spectroscopy (fNIRS) during 4 tasks that engage the childs perceptual and cognitive skills over a period of 18 months. The performance scores obtained by each participants as well as the cortical activity will be analysed and decrypted.",[111],"Deafness",[113,114,115],"Functional Neuroimaging","Profound and Severe Hearing Loss","Cochlear implant","2024-10-21",{"date":118,"type":119},"2024-10-23","ACTUAL",{"date":121,"type":119},"2020-05-29",{"date":123,"type":105},"2026-06-03",{"name":5,"class":6},1]