<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04495660</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/18/0047</org_study_id>
    <nct_id>NCT04495660</nct_id>
  </id_info>
  <brief_title>Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS</brief_title>
  <acronym>HearCog</acronym>
  <official_title>Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The principal aim of this study is to evaluate the cortical developement of perceptual skills&#xD;
      and executive functions over time, in children with cochlear implants aged 10-24 months and&#xD;
      3-7 years compared with normally hearing subjects (NHS). To do this, the investigator will&#xD;
      use functional Near InfraRed Spectroscopy (fNIRS) during 4 tasks that engage the childs&#xD;
      perceptual and cognitive skills over a period of 18 months. The performance scores obtained&#xD;
      by each participants as well as the cortical activity will be analysed and decrypted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When confronted with a severe to profound congenital bilateral hearing loss, cochlear&#xD;
      implantation is considered to be the preferential treatment method as it restaures auditory&#xD;
      function and enables language acquisition for communication purposes. When cochlear&#xD;
      implantation is done before 2 and a half years old, better results are obtained in terms of&#xD;
      language, communication and social developement, as well as reading skills. However when a&#xD;
      cochlear implantation occurs between 2 and 5 years of age, speech and language skills do&#xD;
      develop but communication and reading skills are altered. Therefore, when a cochlear implant&#xD;
      is placed before the age of 2 and a half we find ourselves within the maximal cerebral&#xD;
      plasticity window for speech, language and communication developement.&#xD;
&#xD;
      This study is divided into two cohorts, the first aged 10-24 months and the second 3-7 years.&#xD;
      All children will be seen for 5 sessions, spread out at regular intervals, over a period of&#xD;
      18 months and will participate in two perceptual tasks and two cognitive tasks. The children&#xD;
      will also have a speech and language assessment at T-0 and T+12. The cochlear implanted&#xD;
      patients will continue to be seen by the ENT service and the sessions will be organised to&#xD;
      coincide with their natural follow up. As it is a non-interventional study, no follow-up&#xD;
      would be needed. After the study patients will continue to receive the same quality of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 29, 2020</start_date>
  <completion_date type="Anticipated">June 3, 2026</completion_date>
  <primary_completion_date type="Anticipated">June 3, 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evolution of Oxyhemoglobin (O2Hb) measure</measure>
    <time_frame>60 months</time_frame>
    <description>Oxyhemoglobin (O2Hb) rates measured on the auditory cortex during an auditory stimulus.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evolution of Deoxyhemoglobin (HHb) measure</measure>
    <time_frame>60 months</time_frame>
    <description>Deoxyhemoglobin (HHb) rates measured on the auditory cortex during an auditory stimulus.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Activation of the cortical area for children with normal hearing and children benefiting from CI</measure>
    <time_frame>60 months</time_frame>
    <description>Describe the evolution of the perceptual capacities of children benefiting from CI, compared to the typical development in children with normal hearing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Look the executive function when performing tasks describe in Arms and intervention chapter, between children with normal hearing and children benefiting from CI</measure>
    <time_frame>60 months</time_frame>
    <description>Describe the evolution of the executive functions of children benefiting from CI, compared to the typical development in normal hearing children</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of link between the evolution of perceptual hearing skills and the development of post-implantation language skills.</measure>
    <time_frame>60 months</time_frame>
    <description>Evolution of language.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Make activation cards of the cortical reorganization between these two groups</measure>
    <time_frame>60 months</time_frame>
    <description>Describe the cortical reorganization of the auditory area post implantation. performances obtained during perceptual anc cognitive tasks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Make activation cards of the cortical reorganization between these two groups</measure>
    <time_frame>60 months</time_frame>
    <description>Describe the cortical reorganization of the visual area post implantation. performances obtained during perceptual anc cognitive tasks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison</measure>
    <time_frame>60 months</time_frame>
    <description>Correlation of link between cortical activation in post-implantation fNIRS and:&#xD;
perceptual and executive functions over time in deep deaf children after CI;&#xD;
language skills over time in deep deaf children after CI.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Deafness</condition>
  <arm_group>
    <arm_group_label>Severe/profoundly deaf children 10-24 months old</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The cohort 1 includes patients aged 10-24 months old about to be implanted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe/profoundly deaf children 3-7 years old</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The cohort 2 includes 3-7 years old cochlear implanted patients (implanted before 24 months of age)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normally hearing children 10-24 months old</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The cohort 1 includes patients aged 10-24 months matched in age and sex with normally hearing children</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normally hearing children 3-7 years old</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The cohort 2 includes 3-7 years old matched in sex and age with cochlear implanted patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Near InfraRed Spectroscopy (fNIRS)</intervention_name>
    <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</description>
    <arm_group_label>Normally hearing children 10-24 months old</arm_group_label>
    <arm_group_label>Normally hearing children 3-7 years old</arm_group_label>
    <arm_group_label>Severe/profoundly deaf children 10-24 months old</arm_group_label>
    <arm_group_label>Severe/profoundly deaf children 3-7 years old</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Passive perceptual stimulation</intervention_name>
    <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.</description>
    <arm_group_label>Normally hearing children 10-24 months old</arm_group_label>
    <arm_group_label>Normally hearing children 3-7 years old</arm_group_label>
    <arm_group_label>Severe/profoundly deaf children 10-24 months old</arm_group_label>
    <arm_group_label>Severe/profoundly deaf children 3-7 years old</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Task A not B</intervention_name>
    <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</description>
    <arm_group_label>Normally hearing children 10-24 months old</arm_group_label>
    <arm_group_label>Severe/profoundly deaf children 10-24 months old</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>VSWMT task</intervention_name>
    <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.</description>
    <arm_group_label>Normally hearing children 10-24 months old</arm_group_label>
    <arm_group_label>Normally hearing children 3-7 years old</arm_group_label>
    <arm_group_label>Severe/profoundly deaf children 10-24 months old</arm_group_label>
    <arm_group_label>Severe/profoundly deaf children 3-7 years old</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Perceptual Go-No-Go</intervention_name>
    <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</description>
    <arm_group_label>Normally hearing children 3-7 years old</arm_group_label>
    <arm_group_label>Severe/profoundly deaf children 3-7 years old</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Verbal memory task</intervention_name>
    <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.</description>
    <arm_group_label>Normally hearing children 3-7 years old</arm_group_label>
    <arm_group_label>Severe/profoundly deaf children 3-7 years old</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The sensory room</intervention_name>
    <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</description>
    <arm_group_label>Normally hearing children 10-24 months old</arm_group_label>
    <arm_group_label>Severe/profoundly deaf children 10-24 months old</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria:&#xD;
&#xD;
        Cohort 1 :&#xD;
&#xD;
          -  10-24 months old children will be included.&#xD;
&#xD;
          -  All participants have to be affiliated to the social health security system and&#xD;
             parental consent is obligatory.&#xD;
&#xD;
          -  All congenitally deaf patients will have a severe to profound hearing loss and about&#xD;
             to be fitted with a cochlear implant.&#xD;
&#xD;
          -  Normally hearing counterparts shall have normal hearing as evidenced by acoustical&#xD;
             otoemissions (AOE) in both ears.&#xD;
&#xD;
        Cohort 2 :&#xD;
&#xD;
          -  3-7 years old children will be included.&#xD;
&#xD;
          -  All participants have to be affiliated to the social health security system and&#xD;
             parental consent is obligatory.&#xD;
&#xD;
          -  All congenitally deaf patients will have a cochlear implant, and they will have been&#xD;
             implanted before 2 years of age.&#xD;
&#xD;
          -  Normally hearing counterparts shall have normal hearing as evidenced by acoustical&#xD;
             otoemissions (AOE) in both ears.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria include psycho-neurological diseases, other sensorineural or motor&#xD;
             deficiency, familial bilingualism, medications affecting vigilance and child whose&#xD;
             both parents benefit from a legal protection measure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Months</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yohan GALLOIS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yohan GALLOIS, MD</last_name>
    <phone>5 61 77 85 97</phone>
    <phone_ext>+33</phone_ext>
    <email>gallois.y@chu-toulouse.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Gallois Yohan</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yoahn Gallois</last_name>
      <phone>5 61 73 73 71</phone>
      <phone_ext>+33</phone_ext>
      <email>gallois.y@chu-toulouse.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>July 21, 2023</last_update_submitted>
  <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Functional Neuroimaging</keyword>
  <keyword>Profound and Severe Hearing Loss</keyword>
  <keyword>Cochlear implant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deafness</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04495660
org study id: RC31/18/0047
nct id: NCT04495660
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Evolution of Oxyhemoglobin (O2Hb) measure
time frame: 60 months
description: Oxyhemoglobin (O2Hb) rates measured on the auditory cortex during an auditory stimulus.
measure: Evolution of Deoxyhemoglobin (HHb) measure
time frame: 60 months
description: Deoxyhemoglobin (HHb) rates measured on the auditory cortex during an auditory stimulus.
measure: Activation of the cortical area for children with normal hearing and children benefiting from CI
time frame: 60 months
description: Describe the evolution of the perceptual capacities of children benefiting from CI, compared to the typical development in children with normal hearing
measure: 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
description: Describe the evolution of the executive functions of children benefiting from CI, compared to the typical development in normal hearing children
measure: Correlation of link between the evolution of perceptual hearing skills and the development of post-implantation language skills.
time frame: 60 months
description: Evolution of language.
measure: Make activation cards of the cortical reorganization between these two groups
time frame: 60 months
description: Describe the cortical reorganization of the auditory area post implantation. performances obtained during perceptual anc cognitive tasks
measure: Make activation cards of the cortical reorganization between these two groups
time frame: 60 months
description: Describe the cortical reorganization of the visual area post implantation. performances obtained during perceptual anc cognitive tasks
measure: Comparison
time frame: 60 months
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.
arm group label: Severe/profoundly deaf children 10-24 months old
arm group type: Experimental
description: The cohort 1 includes patients aged 10-24 months old about to be implanted
arm group label: Severe/profoundly deaf children 3-7 years old
arm group type: Experimental
description: The cohort 2 includes 3-7 years old cochlear implanted patients (implanted before 24 months of age)
arm group label: Normally hearing children 10-24 months old
arm group type: Other
description: The cohort 1 includes patients aged 10-24 months matched in age and sex with normally hearing children
arm group label: Normally hearing children 3-7 years old
arm group type: Other
description: The cohort 2 includes 3-7 years old matched in sex and age with cochlear implanted patients
intervention type: Device
intervention name: Near InfraRed Spectroscopy (fNIRS)
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
arm group label: Normally hearing children 10-24 months old
arm group label: Normally hearing children 3-7 years old
arm group label: Severe/profoundly deaf children 10-24 months old
arm group label: Severe/profoundly deaf children 3-7 years old
intervention type: Behavioral
intervention name: Passive perceptual stimulation
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.
arm group label: Normally hearing children 10-24 months old
arm group label: Normally hearing children 3-7 years old
arm group label: Severe/profoundly deaf children 10-24 months old
arm group label: Severe/profoundly deaf children 3-7 years old
intervention type: Behavioral
intervention name: Task A not B
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
arm group label: Normally hearing children 10-24 months old
arm group label: Severe/profoundly deaf children 10-24 months old
intervention type: Behavioral
intervention name: VSWMT task
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.
arm group label: Normally hearing children 10-24 months old
arm group label: Normally hearing children 3-7 years old
arm group label: Severe/profoundly deaf children 10-24 months old
arm group label: Severe/profoundly deaf children 3-7 years old
intervention type: Behavioral
intervention name: Perceptual Go-No-Go
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
arm group label: Normally hearing children 3-7 years old
arm group label: Severe/profoundly deaf children 3-7 years old
intervention type: Behavioral
intervention name: Verbal memory task
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.
arm group label: Normally hearing children 3-7 years old
arm group label: Severe/profoundly deaf children 3-7 years old
intervention type: Behavioral
intervention name: The sensory room
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
arm group label: Normally hearing children 10-24 months old
arm group label: Severe/profoundly deaf children 10-24 months old
criteria: 
gender: All
minimum age: 10 Months
maximum age: 7 Years
healthy volunteers: No
last name: Yohan GALLOIS, MD
role: Principal Investigator
affiliation: University Hospital, Toulouse
last name: Yohan GALLOIS, MD
phone: 5 61 77 85 97
phone ext: +33
email: gallois.y@chu-toulouse.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Deafness