Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in FNIRS
- Conditions
- Deafness
- Interventions
- Device: Near InfraRed Spectroscopy (fNIRS)Behavioral: Passive perceptual stimulationBehavioral: VSWMT taskBehavioral: Task A not BBehavioral: Perceptual Go-No-GoBehavioral: The sensory roomBehavioral: Verbal memory task
- Registration Number
- NCT04495660
- Lead Sponsor
- University Hospital, Toulouse
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Severe/profoundly deaf children 10-24 months old Near InfraRed Spectroscopy (fNIRS) The cohort 1 includes patients aged 10-24 months old about to be implanted Severe/profoundly deaf children 10-24 months old Passive perceptual stimulation The cohort 1 includes patients aged 10-24 months old about to be implanted Severe/profoundly deaf children 3-7 years old Near InfraRed Spectroscopy (fNIRS) The cohort 2 includes 3-7 years old cochlear implanted patients (implanted before 24 months of age) Severe/profoundly deaf children 10-24 months old The sensory room The cohort 1 includes patients aged 10-24 months old about to be implanted Severe/profoundly deaf children 3-7 years old Verbal memory task The cohort 2 includes 3-7 years old cochlear implanted patients (implanted before 24 months of age) Normally hearing children 3-7 years old Near InfraRed Spectroscopy (fNIRS) The cohort 2 includes 3-7 years old matched in sex and age with cochlear implanted patients Normally hearing children 3-7 years old VSWMT task The cohort 2 includes 3-7 years old matched in sex and age with cochlear implanted patients Normally hearing children 10-24 months old Task A not B The cohort 1 includes patients aged 10-24 months matched in age and sex with normally hearing children Severe/profoundly deaf children 10-24 months old Task A not B The cohort 1 includes patients aged 10-24 months old about to be implanted Severe/profoundly deaf children 10-24 months old VSWMT task The cohort 1 includes patients aged 10-24 months old about to be implanted Severe/profoundly deaf children 3-7 years old VSWMT task The cohort 2 includes 3-7 years old cochlear implanted patients (implanted before 24 months of age) Severe/profoundly deaf children 3-7 years old Perceptual Go-No-Go The cohort 2 includes 3-7 years old cochlear implanted patients (implanted before 24 months of age) Normally hearing children 10-24 months old VSWMT task The cohort 1 includes patients aged 10-24 months matched in age and sex with normally hearing children Normally hearing children 3-7 years old Verbal memory task The cohort 2 includes 3-7 years old matched in sex and age with cochlear implanted patients Severe/profoundly deaf children 3-7 years old Passive perceptual stimulation The cohort 2 includes 3-7 years old cochlear implanted patients (implanted before 24 months of age) Normally hearing children 3-7 years old Passive perceptual stimulation The cohort 2 includes 3-7 years old matched in sex and age with cochlear implanted patients Normally hearing children 10-24 months old Near InfraRed Spectroscopy (fNIRS) The cohort 1 includes patients aged 10-24 months matched in age and sex with normally hearing children Normally hearing children 10-24 months old Passive perceptual stimulation The cohort 1 includes patients aged 10-24 months matched in age and sex with normally hearing children Normally hearing children 10-24 months old The sensory room The cohort 1 includes patients aged 10-24 months matched in age and sex with normally hearing children Normally hearing children 3-7 years old Perceptual Go-No-Go The cohort 2 includes 3-7 years old matched in sex and age with cochlear implanted patients
- Primary Outcome Measures
Name Time Method Evolution of Oxyhemoglobin (O2Hb) measure 60 months Oxyhemoglobin (O2Hb) rates measured on the auditory cortex during an auditory stimulus.
Evolution of Deoxyhemoglobin (HHb) measure 60 months Deoxyhemoglobin (HHb) rates measured on the auditory cortex during an auditory stimulus.
- Secondary Outcome Measures
Name Time Method Activation of the cortical area for children with normal hearing and children benefiting from CI 60 months Describe the evolution of the perceptual capacities of children benefiting from CI, compared to the typical development in children with normal hearing
Look the executive function when performing tasks describe in Arms and intervention chapter, between children with normal hearing and children benefiting from CI 60 months Describe the evolution of the executive functions of children benefiting from CI, compared to the typical development in normal hearing children
Comparison 60 months Correlation of link between cortical activation in post-implantation fNIRS and:
* perceptual and executive functions over time in deep deaf children after CI;
* language skills over time in deep deaf children after CI.Correlation of link between the evolution of perceptual hearing skills and the development of post-implantation language skills. 60 months Evolution of language.
Make activation cards of the cortical reorganization between these two groups 60 months Describe the cortical reorganization of the visual area post implantation. performances obtained during perceptual anc cognitive tasks
Trial Locations
- Locations (1)
Gallois Yohan
🇫🇷Toulouse, France