- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04495660
Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS (HearCog)
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yohan GALLOIS, MD
- Phone Number: +33 5 61 77 85 97
- Email: gallois.y@chu-toulouse.fr
Study Locations
-
-
-
Toulouse, France
- Recruiting
- Gallois Yohan
-
Contact:
- Yoahn Gallois
- Phone Number: +33 5 61 73 73 71
- Email: gallois.y@chu-toulouse.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Severe/profoundly deaf children 10-24 months old
The cohort 1 includes patients aged 10-24 months old about to be implanted
|
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: 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: 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: 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 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
|
Experimental: 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)
|
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: 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: 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: 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 :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.
|
Other: 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
|
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: 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: 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: 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 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
|
Other: Normally hearing children 3-7 years old
The cohort 2 includes 3-7 years old matched in sex and age with cochlear implanted patients
|
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: 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: 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: 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 :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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evolution of Oxyhemoglobin (O2Hb) measure
Time Frame: 60 months
|
Oxyhemoglobin (O2Hb) rates measured on the auditory cortex during an auditory stimulus.
|
60 months
|
Evolution of Deoxyhemoglobin (HHb) measure
Time Frame: 60 months
|
Deoxyhemoglobin (HHb) rates measured on the auditory cortex during an auditory stimulus.
|
60 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activation of the cortical area for children with normal hearing and children benefiting from CI
Time Frame: 60 months
|
Describe the evolution of the perceptual capacities of children benefiting from CI, compared to the typical development in children with normal hearing
|
60 months
|
Look the executive function when performing tasks describe in Arms and intervention chapter, between children with normal hearing and children benefiting from CI
Time Frame: 60 months
|
Describe the evolution of the executive functions of children benefiting from CI, compared to the typical development in normal hearing children
|
60 months
|
Correlation of link between the evolution of perceptual hearing skills and the development of post-implantation language skills.
Time Frame: 60 months
|
Evolution of language.
|
60 months
|
Make activation cards of the cortical reorganization between these two groups
Time Frame: 60 months
|
Describe the cortical reorganization of the auditory area post implantation.
performances obtained during perceptual anc cognitive tasks
|
60 months
|
Make activation cards of the cortical reorganization between these two groups
Time Frame: 60 months
|
Describe the cortical reorganization of the visual area post implantation.
performances obtained during perceptual anc cognitive tasks
|
60 months
|
Comparison
Time Frame: 60 months
|
Correlation of link between cortical activation in post-implantation fNIRS and:
|
60 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yohan GALLOIS, MD, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/18/0047
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Deafness
-
RWTH Aachen UniversityAdvanced BionicsCompletedDeafness, Bilateral | Deafness Unilateral | Deafness Congenital | Deafness, AcquiredGermany
-
Oticon MedicalCompletedUnilateral Deafness | Bone Conduction Deafness | Mixed Hearing Loss | Middle Ear DeafnessNetherlands
-
Oticon MedicalCompletedUnilateral Deafness | Bone Conduction Deafness | Mixed Hearing Loss | Middle Ear DeafnessNetherlands
-
Radboud University Medical CenterCochlearRecruitingDeafness, Bilateral | Deafness Neurosensory | Deafness PermanentNetherlands
-
University of North Carolina, Chapel HillMed-El CorporationRecruitingHearing Loss | Congenital Hearing Loss | Hearing Loss, Unilateral | Single Sided Deafness | Unilateral Deafness | Deafness One EarUnited States
-
Dr. Daniel LeeUniversity of Wisconsin, MadisonTerminatedTotal Unilateral Deafness | Unilateral Partial DeafnessUnited States
-
Clinica Universidad de Navarra, Universidad de...University Hospital, Montpellier; University Hospital, Toulouse; Asociacion Instituto... and other collaboratorsUnknownCongenital Deafness | Suspicion of Congenital DeafnessFrance
-
Hôpital RothschildCompletedDeafness; Perception, Bilateral
-
University of Colorado, DenverNational Institute on Deafness and Other Communication Disorders (NIDCD); University...CompletedCongenital Sensorineural DeafnessUnited States
-
University Hospital, GrenobleCentre National de la Recherche Scientifique, FranceCompletedDeafness; Perception, BilateralFrance
Clinical Trials on Near InfraRed Spectroscopy (fNIRS)
-
Centre Hospitalier Régional d'OrléansCompleted
-
Hangang Sacred Heart HospitalNational Research Foundation of KoreaCompletedWalkingKorea, Republic of
-
Centre Hospitalier Régional d'OrléansRecruiting
-
Centre Hospitalier Régional d'OrléansRecruiting
-
The First Affiliated Hospital of Zhengzhou UniversityRecruitingCortical Function Changes During Swallowing in Patients With Dysphagia in Lateral Medullary SyndromeDeglutition Disorders | Lateral Medullary SyndromeChina
-
Taipei Veterans General Hospital, TaiwanUnknownCentral Nervous System DiseasesTaiwan
-
Centre Hospitalier Universitaire de NīmesCompleted
-
Lawson Health Research InstituteRecruitingStroke | Cerebral OxygenationCanada
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, France; University... and other collaboratorsCompletedProfound Congenital Deaf Children ImplantedFrance
-
University of California, IrvineBeckman Laser Institute University of California Irvine; Brooke Army Medical...CompletedHemorrhagic ShockUnited States