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Can brain scans reveal how cochlear implants rewire a Child's hearing and thinking?

NCT ID NCT04495660

Knowledge-focused Sponsor: University Hospital, Toulouse Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

Researchers are using a brain imaging technique called fNIRS to track how deaf children's brains develop after receiving a cochlear implant. The study includes children aged 10-24 months and 3-7 years, comparing them with normally hearing peers over 18 months. During tasks that test hearing and thinking, the imaging cap measures brain activity in areas linked to sound and executive function. The goal is to see how perceptual and cognitive skills evolve in implanted children compared to typical development.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Functional near-infrared spectroscopy (fNIRS) brain imaging, a non-invasive cap that measures brain activity during hearing and thinking tasks
What this could lead to
If this works, it could reveal how deaf children's brains adapt after cochlear implants, guiding better rehabilitation and support for language and thinking skills.
What could go wrong
This is an observational imaging study, not a treatment test. It may not capture all brain changes, and results may not apply to every child with a cochlear implant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2020

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 months to 7 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Deafness hearing loss disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Deafness

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Gallois Yohan

    RECRUITING

    Toulouse, France

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