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

RecruitingNAAges 10 Months - 7 YearsAllUniversity Hospital, Toulouse
NCT04495660 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Near InfraRed Spectroscopy (fNIRS)
  • Passive perceptual stimulation
  • Task A not B
  • VSWMT task
  • Perceptual Go-No-Go
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Where

1 site
Gallois Yohan
Toulouse, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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