Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS

Deafness Clinical Trial

— HearCog  

Official title:

Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04495660
• Other study ID #: RC31/18/0047
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2020
• Est. completion date: June 3, 2026

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: Yohan GALLOIS, MD
• Phone: 5 61 77 85 97
• Email: gallois.y[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 3, 2026
• Est. primary completion date: June 3, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Months to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness

Intervention

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

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.
• 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
• 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.
• 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
• 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.
• 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

Locations

Country	Name	City	State
France	Gallois Yohan	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of Oxyhemoglobin (O2Hb) measure	Oxyhemoglobin (O2Hb) rates measured on the auditory cortex during an auditory stimulus.	60 months
Primary	Evolution of Deoxyhemoglobin (HHb) measure	Deoxyhemoglobin (HHb) rates measured on the auditory cortex during an auditory stimulus.	60 months
Secondary	Activation of the cortical area for children with normal hearing and children benefiting from CI	Describe the evolution of the perceptual capacities of children benefiting from CI, compared to the typical development in children with normal hearing	60 months
Secondary	Look the executive function when performing tasks describe in Arms and intervention chapter, between children with normal hearing and children benefiting from CI	Describe the evolution of the executive functions of children benefiting from CI, compared to the typical development in normal hearing children	60 months
Secondary	Correlation of link between the evolution of perceptual hearing skills and the development of post-implantation language skills.	Evolution of language.	60 months
Secondary	Make activation cards of the cortical reorganization between these two groups	Describe the cortical reorganization of the auditory area post implantation. performances obtained during perceptual anc cognitive tasks	60 months
Secondary	Make activation cards of the cortical reorganization between these two groups	Describe the cortical reorganization of the visual area post implantation. performances obtained during perceptual anc cognitive tasks	60 months
Secondary	Comparison	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.	60 months