Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in FNIRS (HearCog)

Toulouse University Hospital

Status: Enrolling

Conditions: Deafness

Treatments: Device: Near InfraRed Spectroscopy (fNIRS); Behavioral: Verbal memory task; Behavioral: Task A not B; Behavioral: VSWMT task; Behavioral: The sensory room; Behavioral: Passive perceptual stimulation; Behavioral: Perceptual Go-No-Go

Study type: Interventional

Funder types: Other

Identifiers

NCT04495660

RC31/18/0047

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 10 months to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Severe/profoundly deaf children 10-24 months old

Experimental group

Description:

The cohort 1 includes patients aged 10-24 months old about to be implanted

Treatment:

Behavioral: The sensory room

Behavioral: VSWMT task

Behavioral: Passive perceptual stimulation

Behavioral: Task A not B

Device: Near InfraRed Spectroscopy (fNIRS)

Severe/profoundly deaf children 3-7 years old

Experimental group

Description:

The cohort 2 includes 3-7 years old cochlear implanted patients (implanted before 24 months of age)

Treatment:

Behavioral: Perceptual Go-No-Go

Behavioral: VSWMT task

Behavioral: Passive perceptual stimulation

Behavioral: Verbal memory task

Device: Near InfraRed Spectroscopy (fNIRS)

Normally hearing children 10-24 months old

Other group

Description:

The cohort 1 includes patients aged 10-24 months matched in age and sex with normally hearing children

Treatment:

Behavioral: The sensory room

Behavioral: VSWMT task

Behavioral: Passive perceptual stimulation

Behavioral: Task A not B

Device: Near InfraRed Spectroscopy (fNIRS)

Normally hearing children 3-7 years old

Other group

Description:

The cohort 2 includes 3-7 years old matched in sex and age with cochlear implanted patients

Treatment:

Behavioral: Perceptual Go-No-Go

Behavioral: VSWMT task

Behavioral: Passive perceptual stimulation

Behavioral: Verbal memory task

Device: Near InfraRed Spectroscopy (fNIRS)