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NCT Number: NCT06024122

Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study

Concussions (also known as mild traumatic brain injury) are common in young children. In some children, they can lead to short- and long-term difficulties. However, our knowledge of the exact consequences of injuries on young children's brains and behavior is limited. These consequences may be different in children under 6, as their brains are fragile and undergoing significant developmental changes.

The aim of this study is to determine the extent to which a concussion sustained before the age of 6 years is associated with changes in young children's brain structure, function and behaviours, using a brain imaging.

In this study, the results of a group of 30 children with a concussion will be compared to those of 30 children of the same age with an orthopaedic injury to the upper or lower limbs.

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Key information

Age range

36 month–71 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Unité des urgences médicochirurgicales CHU Rennes

Rennes, 35200, France

Location status: Recruiting

Location contact

Véronique Chasle, MD

CONTACT

[email protected]

+33 2 99 26 67 58

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient group with mild traumatic brain injury (mTBI) :
  • Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday)
  • Presentation to the emergency department within 48 hours post-injury
  • Documented, unintentional traumatic event (e.g. blow, fall, etc.) resulting in non-penetrating head injury
  • Diagnosis of mTBI (World Health Organization (WHO) paediatric diagnostic criteria)
  • Control group with orthopaedic injury:
  • Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday)
  • Presentation to the emergency department within 48 hours post-injury
  • Documented, unintentional traumatic event (e.g. blow, fall, etc.) resulting in trauma to an upper or lower limb
  • 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

Treatment and study plan

IRM exam

Other

A non-sedated MRI scan will be performed to assess the structure and function of the children's brains

Primary outcomes

  1. Persistent brain structure alterations

    Time frame: 3 months post-injury

    Quantitative assessment of the brain morphometry extracted from T1-w MRI sequence

Secondary outcomes

  1. Persistent brain lesions - Volume

    Time frame: 3 months post-injury

    Volume of brain lesions measured with susceptibility MRI

  2. Persistent brain lesions - Number

    Time frame: 3 months post-injury

    Number brain lesions measured with susceptibility MRI

  3. Cerebral blood flow alteration

    Time frame: 3 months post-injury

    Cerebral blood flow quantified by arterial spin labelling perfusion MRI (ASL)

  4. Functional integrity of brain networks

    Time frame: 3 months post-injury

    Functional connectivity (i.e., correlation between the activation of brain regions) measured by resting-state functional MRI

  5. Structural integrity of brain networks

    Time frame: 3 months post-injury

    White matter micro-structure measured by diffusion MRI

Other outcomes

  1. Acute and persistent post-concussive symptoms

    Time frame: Through study completion, an average of 3 months

    Assessment of post-concussive symptoms using the REACTIONS questionnaire

  2. Persistent behavioural difficulties

    Time frame: 3 months post-injury

    Assessment of behaviour using the Strengths and Difficulties Questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Fanny DÉGEILH, PhD

CONTACT

[email protected]

+33 2 99 84 71 63

Véronique CHASLE, MD

CONTACT

[email protected]

+33 2 99 26 67 58

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Collaborators

  • Institut National de Recherche en Informatique et en Automatique

Registry information

Acronym: KAOUENN

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 6, 2023
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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