Actively Recruiting
Restoration of Auditory and Cognitive Functions in Cochlear Implanted Deaf Children Using Functional Near InfraRed Spectroscopy (fNIRS)
Led by University Hospital, Toulouse · Updated on 2024-10-23
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how perceptual skills and executive functions develop in children with cochlear implants compared to children with normal hearing. The study focuses on two groups: children aged 10 to 24 months who are about to receive cochlear implants, and children aged 3 to 7 years who were implanted before 2 years of age. The goal is to understand brain activity and skill development over time using a special imaging technique called functional Near InfraRed Spectroscopy (fNIRS). Children in both groups will participate in a series of five sessions over 18 months. During these sessions, they will complete four tasks designed to engage their perception and cognition, including watching videos, playing hiding games, and memory tasks. The fNIRS device, which uses a cap with sensors, will measure brain activity during these tasks. Speech and language assessments will be done at the start and after 12 months. This study is non-interventional, meaning no changes will be made to their usual care. Participants will be evaluated through brain imaging, cognitive and perceptual tasks, and speech assessments. The study will analyze changes in oxygen levels in the brain and look at how brain areas activate during tasks. Patients will continue their usual care with ear, nose, and throat specialists, and the study sessions will be scheduled to align with their regular medical visits. The total study duration for each child is 18 months, with no extra follow-up required after the study ends.
CONDITIONS
Brief Title
Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in FNIRS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 10 to 24 months or 3 to 7 years
- Affiliated to the social health security system
- Parental consent is required
- Cohort 1: Congenitally deaf children aged 10-24 months about to receive a cochlear implant
- Cohort 2: Children aged 3-7 years with cochlear implants placed before 2 years of age
- Normally hearing children matched by age and sex for comparison
You will not qualify if you...
- Psycho-neurological diseases
- Other sensorineural or motor deficiencies
- Familial bilingualism
- Medications affecting vigilance
- Children whose both parents are under legal protection measures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 18 months
Participants undergo non-invasive functional neuroimaging using functional Near InfraRed Spectroscopy (fNIRS) during several cognitive and perceptual tasks to assess auditory and cognitive function.
5 visits spaced at regular intervals over 18 months
Trial Site Locations
Total: 1 location
1
Gallois Yohan
Toulouse, France
Actively Recruiting
Research Team
Y
Yohan GALLOIS, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
4
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