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Concussion before age 6: what happens to a Child's brain?

NCT ID NCT06024122

Knowledge-focused Sponsor: Institut National de la Santé Et de la Recherche Médicale, France 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how a concussion (mild traumatic brain injury) before age 6 might change brain structure and behavior. Researchers will use MRI scans to compare 30 children who had a concussion with 30 children who had a limb injury. The goal is to better understand the short- and long-term effects of concussion on the developing brain.

What this could mean

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

What this could lead to
If successful, this study could reveal how concussions affect young children's brains, guiding better diagnosis and follow-up care.
What could go wrong
This is a small pilot study with only 60 children, so results may not apply to all kids. It observes changes but does not test any treatment.

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.

Participants

About 60 people

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

Started

Jul 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Who is studied

Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday) with mTBI. Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday) with orthopaedic injury (simple fracture, sprain, contusion or unspecified trauma to a limb (mild))

Ages

36 to 71 months

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: * Patient group with mild traumatic brain injury (mTBI) : 1. Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday) 2. Presentation to the emergency department within 48 hours post-injury 3. Documented, unintentional traumatic event (e.g. blow, fall, etc.) resulting in non-penetrating head injury 4. Diagnosis of mTBI (World Health Organization (WHO) paediatric diagnostic criteria) * Control group with orthopaedic injury: 1. Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday) 2. Presentation to the emergency department within 48 hours post-injury 3. Documented, unintentional traumatic event (e.g. blow, fall, etc.) resulting in trauma to an upper or lower limb 4. Diagnosis of simple fracture, sprain, contusion or unspecified trauma to a limb (mild). Exclusion Criteria: * Diagnosis of previous TBI (any severity, any age) * Intentional injury, * Administration of sedative drugs that can alter brain function * Complications following injury * MRI contraindication, * Parent non-fluent in French, * Prematurity, * Diagnosis of a severe neurological, developmental, or psychiatric disorder * Children in foster care at the time of recruitment

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

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

TBI (traumatic brain injury)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Unité des urgences médicochirurgicales CHU Rennes

    RECRUITING

    Rennes, 35200, France

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