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

NCT04495660 | Recruiting

• 1 other identifier: RC31/18/0047
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Deafness

Keywords

Functional Neuroimaging; Profound and Severe Hearing Loss; Cochlear implant

Outcome Measures

Primary Outcomes (2)

• Evolution of Oxyhemoglobin (O2Hb) measure

  Oxyhemoglobin (O2Hb) rates measured on the auditory cortex during an auditory stimulus.

  60 months

• Evolution of Deoxyhemoglobin (HHb) measure

  Deoxyhemoglobin (HHb) rates measured on the auditory cortex during an auditory stimulus.

  60 months

Secondary Outcomes (6)

• Activation of the cortical area for children with normal hearing and children benefiting from CI

  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

  60 months

• Correlation of link between the evolution of perceptual hearing skills and the development of post-implantation language skills.

  60 months

• Make activation cards of the cortical reorganization between these two groups

  60 months

• Make activation cards of the cortical reorganization between these two groups

  60 months

Study Arms (4)

Severe/profoundly deaf children 10-24 months old

EXPERIMENTAL

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

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)

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

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

Device: Near InfraRed Spectroscopy (fNIRS); Behavioral: Passive perceptual stimulation; Behavioral: VSWMT task; Behavioral: Perceptual Go-No-Go; Behavioral: Verbal memory task

Interventions

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

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 stimulation BEHAVIORAL

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.

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 B BEHAVIORAL

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

Normally hearing children 10-24 months old; Severe/profoundly deaf children 10-24 months old

VSWMT task BEHAVIORAL

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.

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-Go BEHAVIORAL

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

Normally hearing children 3-7 years old; Severe/profoundly deaf children 3-7 years old

Verbal memory task BEHAVIORAL

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.

Normally hearing children 3-7 years old; Severe/profoundly deaf children 3-7 years old

The sensory room BEHAVIORAL

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

Normally hearing children 10-24 months old; Severe/profoundly deaf children 10-24 months old

Eligibility Criteria

• Age: 10 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Cohort 1 :
• 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 :
• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Gallois Yohan

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Deafness; Hearing Loss

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Yohan GALLOIS, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yohan GALLOIS, MD

CONTACT

5 61 77 85 97; gallois.y@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: August 3, 2020
• Study Start: May 29, 2020
• Primary Completion: June 3, 2026
• Study Completion: June 3, 2026
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)