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

Primary Purpose

Deafness

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Near InfraRed Spectroscopy (fNIRS)
Passive perceptual stimulation
Task A not B
VSWMT task
Perceptual Go-No-Go
Verbal memory task
The sensory room
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Deafness focused on measuring Functional Neuroimaging, Profound and Severe Hearing Loss, Cochlear implant

Eligibility Criteria

10 Months - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gallois YohanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Other

Other

Arm Label

Severe/profoundly deaf children 10-24 months old

Severe/profoundly deaf children 3-7 years old

Normally hearing children 10-24 months old

Normally hearing children 3-7 years old

Arm Description

The cohort 1 includes patients aged 10-24 months old about to be implanted

The cohort 2 includes 3-7 years old cochlear implanted patients (implanted before 24 months of age)

The cohort 1 includes patients aged 10-24 months matched in age and sex with normally hearing children

The cohort 2 includes 3-7 years old matched in sex and age with cochlear implanted patients

Outcomes

Primary Outcome Measures

Evolution of Oxyhemoglobin (O2Hb) measure
Oxyhemoglobin (O2Hb) rates measured on the auditory cortex during an auditory stimulus.
Evolution of Deoxyhemoglobin (HHb) measure
Deoxyhemoglobin (HHb) rates measured on the auditory cortex during an auditory stimulus.

Secondary Outcome Measures

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
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
Correlation of link between the evolution of perceptual hearing skills and the development of post-implantation language skills.
Evolution of language.
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
Make activation cards of the cortical reorganization between these two groups
Describe the cortical reorganization of the visual area post implantation. performances obtained during perceptual anc cognitive tasks
Comparison
Correlation of link between cortical activation in post-implantation fNIRS and: perceptual and executive functions over time in deep deaf children after CI; language skills over time in deep deaf children after CI.

Full Information

First Posted
June 4, 2020
Last Updated
July 21, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT04495660
Brief Title
Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS
Acronym
HearCog
Official Title
Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 29, 2020 (Actual)
Primary Completion Date
June 3, 2026 (Anticipated)
Study Completion Date
June 3, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness
Keywords
Functional Neuroimaging, Profound and Severe Hearing Loss, Cochlear implant

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Severe/profoundly deaf children 10-24 months old
Arm Type
Experimental
Arm Description
The cohort 1 includes patients aged 10-24 months old about to be implanted
Arm Title
Severe/profoundly deaf children 3-7 years old
Arm Type
Experimental
Arm Description
The cohort 2 includes 3-7 years old cochlear implanted patients (implanted before 24 months of age)
Arm Title
Normally hearing children 10-24 months old
Arm Type
Other
Arm Description
The cohort 1 includes patients aged 10-24 months matched in age and sex with normally hearing children
Arm Title
Normally hearing children 3-7 years old
Arm Type
Other
Arm Description
The cohort 2 includes 3-7 years old matched in sex and age with cochlear implanted patients
Intervention Type
Device
Intervention Name(s)
Near InfraRed Spectroscopy (fNIRS)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Passive perceptual stimulation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Task A not B
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
VSWMT task
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Perceptual Go-No-Go
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Verbal memory task
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The sensory room
Intervention Description
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
Primary Outcome Measure Information:
Title
Evolution of Oxyhemoglobin (O2Hb) measure
Description
Oxyhemoglobin (O2Hb) rates measured on the auditory cortex during an auditory stimulus.
Time Frame
60 months
Title
Evolution of Deoxyhemoglobin (HHb) measure
Description
Deoxyhemoglobin (HHb) rates measured on the auditory cortex during an auditory stimulus.
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Activation of the cortical area for children with normal hearing and children benefiting from CI
Description
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
Title
Look the executive function when performing tasks describe in Arms and intervention chapter, between children with normal hearing and children benefiting from CI
Description
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
Title
Correlation of link between the evolution of perceptual hearing skills and the development of post-implantation language skills.
Description
Evolution of language.
Time Frame
60 months
Title
Make activation cards of the cortical reorganization between these two groups
Description
Describe the cortical reorganization of the auditory area post implantation. performances obtained during perceptual anc cognitive tasks
Time Frame
60 months
Title
Make activation cards of the cortical reorganization between these two groups
Description
Describe the cortical reorganization of the visual area post implantation. performances obtained during perceptual anc cognitive tasks
Time Frame
60 months
Title
Comparison
Description
Correlation of link between cortical activation in post-implantation fNIRS and: perceptual and executive functions over time in deep deaf children after CI; language skills over time in deep deaf children after CI.
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yohan GALLOIS, MD
Phone
5 61 77 85 97
Ext
+33
Email
gallois.y@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yohan GALLOIS, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gallois Yohan
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoahn Gallois
Phone
5 61 73 73 71
Ext
+33
Email
gallois.y@chu-toulouse.fr

12. IPD Sharing Statement

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

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