Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in FNIRS
NCT ID: NCT04495660
Last Updated: 2024-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2020-05-29
2026-06-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Severe/profoundly deaf children 10-24 months old
The cohort 1 includes patients aged 10-24 months old about to be implanted
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
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.
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
Severe/profoundly deaf children 3-7 years old
The cohort 2 includes 3-7 years old cochlear implanted patients (implanted before 24 months of age)
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
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.
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.
Normally hearing children 10-24 months old
The cohort 1 includes patients aged 10-24 months matched in age and sex with normally hearing children
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
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.
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
Normally hearing children 3-7 years old
The cohort 2 includes 3-7 years old matched in sex and age with cochlear implanted patients
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
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.
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.
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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.
10 Months
7 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Yohan GALLOIS, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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Gallois Yohan
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC31/18/0047
Identifier Type: -
Identifier Source: org_study_id
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