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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: University Hospital, Toulouse • ClinicalTrials.gov ID: NCT04495660

Registry updated: 2026-08-31
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Description

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.

Interventions

  • 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

Eligibility criteria

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

Conditions

Deafness

Locations

  • Gallois Yohan — Toulouse, France
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record