DeafnessHearCogNCT04495660
Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS
A study testing Near InfraRed Spectroscopy (fNIRS), Passive perceptual stimulation and Task A not B in people with Deafness, run by University Hospital, Toulouse at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 months to 7 years
- Conditions the study is for
- Deafness
- What is being tested?
- Near InfraRed Spectroscopy (fNIRS), Passive perceptual stimulation and Task A not B
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2020to 3 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 :
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Gallois Yohan
Toulouse
Yoahn Gallois, 5 61 73 73 71 ext. +33, gallois.y@chu-toulouse.fr
About this study
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.
Read the 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.
- Conditions
- Deafness
- Being tested
- Near InfraRed Spectroscopy (fNIRS), Passive perceptual stimulation, Task A not B, VSWMT task, Perceptual Go-No-Go
- Keywords
- Functional Neuroimaging, Profound and Severe Hearing Loss, Cochlear implant
- Medical subject headings
- Deafness, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 stimulationBehavioural
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 BBehavioural
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 taskBehavioural
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-GoBehavioural
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 taskBehavioural
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 roomBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Severe/profoundly deaf children 10-24 months old | Experimental | The cohort 1 includes patients aged 10-24 months old about to be implanted Receives: Device: Near InfraRed Spectroscopy (fNIRS); Behavioral: Passive perceptual stimulation; Behavioral: Task A not B; Behavioral: VSWMT task; Behavioral: The sensory room |
| Severe/profoundly deaf children 3-7 years old | Experimental | The cohort 2 includes 3-7 years old cochlear implanted patients (implanted before 24 months of age) Receives: Device: Near InfraRed Spectroscopy (fNIRS); Behavioral: Passive perceptual stimulation; Behavioral: VSWMT task; Behavioral: Perceptual Go-No-Go; Behavioral: Verbal memory task |
| Normally hearing children 10-24 months old | Other | The cohort 1 includes patients aged 10-24 months matched in age and sex with normally hearing children Receives: Device: Near InfraRed Spectroscopy (fNIRS); Behavioral: Passive perceptual stimulation; Behavioral: Task A not B; Behavioral: VSWMT task; Behavioral: The sensory room |
| Normally hearing children 3-7 years old | Other | The cohort 2 includes 3-7 years old matched in sex and age with cochlear implanted patients Receives: Device: Near InfraRed Spectroscopy (fNIRS); Behavioral: Passive perceptual stimulation; Behavioral: VSWMT task; Behavioral: Perceptual Go-No-Go; Behavioral: Verbal memory task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of Oxyhemoglobin (O2Hb) measure
Oxyhemoglobin (O2Hb) rates measured on the auditory cortex during an auditory stimulus.
Measured: 60 months
Evolution of Deoxyhemoglobin (HHb) measure
Deoxyhemoglobin (HHb) rates measured on the auditory cortex during an auditory stimulus.
Measured: 60 months
Secondary outcomes (6)
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
Measured: 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
Describe the evolution of the executive functions of children benefiting from CI, compared to the typical development in normal hearing children
Measured: 60 months
Correlation of link between the evolution of perceptual hearing skills and the development of post-implantation language skills.
Evolution of language.
Measured: 60 months
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
Measured: 60 months
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
Measured: 60 months
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.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start29 May 2020
- Primary completion3 Jun 2027 (estimated)
- Study completion3 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yohan GALLOIS, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495660
- Sponsor's protocol ID
- RC31/18/0047
- Acronym
- HearCog
- Status last verified
- Aug 2026
- First submitted
- 4 Jun 2020
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS
- ClinicalTrials.gov ID
- NCT04495660
- Acronym / sponsor ID
- HearCog / RC31/18/0047
- Conditions
- Deafness
- Keywords
- Functional Neuroimaging, Profound and Severe Hearing Loss, Cochlear implant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 29 May 2020 (actual)
- Primary completion
- 3 Jun 2027 (estimated)
- Study completion
- 3 Jun 2027 (estimated)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Severe/profoundly deaf children 10-24 months old | Experimental | Device: Near InfraRed Spectroscopy (fNIRS), Behavioral: Passive perceptual stimulation, Behavioral: Task A not B, Behavioral: VSWMT task, Behavioral: The sensory roomThe cohort 1 includes patients aged 10-24 months old about to be implanted |
| Severe/profoundly deaf children 3-7 years old | Experimental | Device: Near InfraRed Spectroscopy (fNIRS), Behavioral: Passive perceptual stimulation, Behavioral: VSWMT task, Behavioral: Perceptual Go-No-Go, Behavioral: Verbal memory taskThe cohort 2 includes 3-7 years old cochlear implanted patients (implanted before 24 months of age) |
| Normally hearing children 10-24 months old | Other | Device: Near InfraRed Spectroscopy (fNIRS), Behavioral: Passive perceptual stimulation, Behavioral: Task A not B, Behavioral: VSWMT task, Behavioral: The sensory roomThe cohort 1 includes patients aged 10-24 months matched in age and sex with normally hearing children |
| Normally hearing children 3-7 years old | Other | Device: Near InfraRed Spectroscopy (fNIRS), Behavioral: Passive perceptual stimulation, Behavioral: VSWMT task, Behavioral: Perceptual Go-No-Go, Behavioral: Verbal memory taskThe cohort 2 includes 3-7 years old matched in sex and age with cochlear implanted patients |
Who may qualify
- Ages
- 10 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
- 3-7 years old children will be included.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Normally hearing children 10-24 months old, Normally hearing children 3-7 years old, Severe/profoundly deaf children 10-24 months old, Severe/profoundly deaf children 3-7 years old |
| Passive perceptual stimulationPassive 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. | Behavioural | Normally hearing children 10-24 months old, Normally hearing children 3-7 years old, Severe/profoundly deaf children 10-24 months old, Severe/profoundly deaf children 3-7 years old |
| Task A not BTask 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 | Behavioural | Normally hearing children 10-24 months old, Severe/profoundly deaf children 10-24 months old |
| VSWMT taskVSWMT 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. | Behavioural | Normally hearing children 10-24 months old, Normally hearing children 3-7 years old, Severe/profoundly deaf children 10-24 months old, Severe/profoundly deaf children 3-7 years old |
| Perceptual Go-No-GoPerceptual 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 | Behavioural | Normally hearing children 3-7 years old, Severe/profoundly deaf children 3-7 years old |
| Verbal memory taskVerbal 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. | Behavioural | Normally hearing children 3-7 years old, Severe/profoundly deaf children 3-7 years old |
| The sensory roomThe 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 | Behavioural | Normally hearing children 10-24 months old, Severe/profoundly deaf children 10-24 months old |
Primary outcome
Evolution of Oxyhemoglobin (O2Hb) measure
Time frame: 60 months
Oxyhemoglobin (O2Hb) rates measured on the auditory cortex during an auditory stimulus.
Evolution of Deoxyhemoglobin (HHb) measure
Time frame: 60 months
Deoxyhemoglobin (HHb) rates measured on the auditory cortex during an auditory stimulus.
6 secondary outcomes
Activation of the cortical area for children with normal hearing and children benefiting from CI
Time frame: 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
Correlation of link between the evolution of perceptual hearing skills and the development of post-implantation language skills.
Time frame: 60 months
Make activation cards of the cortical reorganization between these two groups
Time frame: 60 months
Make activation cards of the cortical reorganization between these two groups
Time frame: 60 months
Comparison
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yohan GALLOIS, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near InfraRed Spectroscopy (fNIRS), Passive perceptual stimulation and Task A not B in people with Deafness, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yohan GALLOIS, MD (5 61 77 85 97 ext. +33, gallois.y@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of Oxyhemoglobin (O2Hb) measure (time frame: 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.