Gallois Yohan
Toulouse, France
Location status: Recruiting
NCT Number: NCT04495660
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.
Interested in participating?
Request Info10 month–7 year
All sexes
Interventional
Not applicable
Toulouse, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Cohort 1 :
Cohort 2 :
Exclusion criteria
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
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.
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
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.
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
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.
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
Time frame: 60 months
Oxyhemoglobin (O2Hb) rates measured on the auditory cortex during an auditory stimulus.
Time frame: 60 months
Deoxyhemoglobin (HHb) rates measured on the auditory cortex during an auditory stimulus.
Time frame: 60 months
Describe the evolution of the perceptual capacities of children benefiting from CI, compared to the typical development in children with normal hearing
Time frame: 60 months
Describe the evolution of the executive functions of children benefiting from CI, compared to the typical development in normal hearing children
Time frame: 60 months
Evolution of language.
Time frame: 60 months
Describe the cortical reorganization of the auditory area post implantation. performances obtained during perceptual anc cognitive tasks
Time frame: 60 months
Describe the cortical reorganization of the visual area post implantation. performances obtained during perceptual anc cognitive tasks
Time frame: 60 months
Correlation of link between cortical activation in post-implantation fNIRS and:
Contact information is provided by the study sponsor or research team.
University Hospital, Toulouse
Other
Acronym: HearCog
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05670496
Behavior, Communication
Bethesda, Maryland, United States
View Trial DetailsNCT05808543
Deafness, Ear Diseases
Birmingham, United Kingdom
View Trial DetailsNCT07380269
Cochlear Implantation, Deafness
Shanghai, China
View Trial DetailsNCT06370351
Congenital Deafness, DFNB9
Westmead, Australia
View Trial Details