Clinical trial NCT04495660: Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in FNIRS
Official title: Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in FNIRS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deafness
Keywords: Functional Neuroimaging
Profound and Severe Hearing Loss
Cochlear implant
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: When confronted with a severe to profound congenital bilateral hearing loss, cochlear implantation is considered to be the preferential treatment method as it restaures auditory function and enables language acquisition for communication purposes. When cochlear implantation is done before 2 and a half years old, better results are obtained in terms of language, communication and social developement, as well as reading skills. However when a cochlear implantation occurs between 2 and 5 years of age, speech and language skills do develop but communication and reading skills are altered. Therefore, when a cochlear implant is placed before the age of 2 and a half we find ourselves within the maximal cerebral plasticity window for speech, language and communication developement.

This study is divided into two cohorts, the first aged 10-24 months and the second 3-7 years. All children will be seen for 5 sessions, spread out at regular intervals, over a period of 18 months and will participate in two perceptual tasks and two cognitive tasks. The children will also have a speech and language assessment at T-0 and T+12. The cochlear implanted patients will continue to be seen by the ENT service and the sessions will be organised to coincide with their natural follow up. As it is a non-interventional study, no follow-up would be needed. After the study patients will continue to receive the same quality of care.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria:

Cohort 1 :

* 10-24 months old children will be included.
* All participants have to be affiliated to the social health security system and parental consent is obligatory.
* All congenitally deaf patients will have a severe to profound hearing loss and about to be fitted with a cochlear implant.
* Normally hearing counterparts shall have normal hearing as evidenced by acoustical otoemissions (AOE) in both ears.

Cohort 2 :

* 3-7 years old children will be included.
* All participants have to be affiliated to the social health security system and parental consent is obligatory.
* All congenitally deaf patients will have a cochlear implant, and they will have been implanted before 2 years of age.
* Normally hearing counterparts shall have normal hearing as evidenced by acoustical otoemissions (AOE) in both ears.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evolution of Oxyhemoglobin (O2Hb) measure
timeFrame: 60 months
measure: Evolution of Deoxyhemoglobin (HHb) measure
timeFrame: 60 months
Secondary outcomes:
measure: Activation of the cortical area for children with normal hearing and children benefiting from CI
timeFrame: 60 months
measure: Look the executive function when performing tasks describe in Arms and intervention chapter, between children with normal hearing and children benefiting from CI
timeFrame: 60 months
measure: Correlation of link between the evolution of perceptual hearing skills and the development of post-implantation language skills.
timeFrame: 60 months
measure: Make activation cards of the cortical reorganization between these two groups
timeFrame: 60 months
measure: Make activation cards of the cortical reorganization between these two groups
timeFrame: 60 months
measure: Comparison
timeFrame: 60 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Gallois Yohan
Study officials:
affiliation: University Hospital, Toulouse
name: Yohan GALLOIS, MD
role: PRINCIPAL_INVESTIGATOR
References: