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

ConditionDeafness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-7
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Near InfraRed Spectroscopy (fNIRS)

    Device

    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

    Behavioral

    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

    Behavioral

    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

    Behavioral

    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

    Behavioral

    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

    Behavioral

    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

    Behavioral

    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

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Severe/profoundly deaf children 10-24 months oldExperimental treatment 5 interventions
Group B: Severe/profoundly deaf children 3-7 years oldExperimental treatment 5 interventions
Group C: Normally hearing children 10-24 months oldOther 5 interventions
Group D: Normally hearing children 3-7 years oldOther 5 interventions

Trial outcomes

Primary outcomes

1

Evolution of Oxyhemoglobin (O2Hb) measure

Oxyhemoglobin (O2Hb) rates measured on the auditory cortex during an auditory stimulus.

Time frame
60 months
2

Evolution of Deoxyhemoglobin (HHb) measure

Deoxyhemoglobin (HHb) rates measured on the auditory cortex during an auditory stimulus.

Time frame
60 months

Secondary outcomes

1

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

Time frame
60 months
2

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

Time frame
60 months
3

Correlation of link between the evolution of perceptual hearing skills and the development of post-implantation language skills.

Evolution of language.

Time frame
60 months
4

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

Time frame
60 months

Other outcomes

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