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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: TBI (Traumatic Brain Injury)
• Intervention / Treatment: Other: IRM exam

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Fanny DÉGEILH, PhD; Phone Number: +33 2 99 84 71 63; Email: fanny.degeilh@inserm.fr
• Study Contact Backup: Name: Véronique Chasle, MD; Phone Number: +33 2 99 26 67 58; Email: veronique.chasle@chu-rennes.fr

Study Locations

• France
  • Rennes, France, 35200
    • Unité des urgences médicochirurgicales CHU Rennes
    • Contact: Véronique Chasle, MD; Phone Number: +33 2 99 26 67 58; Email: veronique.chasle@chu-rennes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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))

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with a mTBI; Children with a mTBI aged 3 to 5 years (i.e., up to 71 months and 31 days, i.e., before the 6th birthday) recruited from the paediatric emergency department of Rennes University Hospital.	Other: IRM exam; A non-sedated MRI scan will be performed to assess the structure and function of the children's brains
Control with an orthopaedic injury; Children with an orthopaedic injury aged 3 to 5 years (i.e., up to 71 months and 31 days, i.e., before the 6th birthday) recruited from the paediatric emergency department of Rennes University Hospital.	Other: IRM exam; A non-sedated MRI scan will be performed to assess the structure and function of the children's brains

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Persistent brain structure alterations	Quantitative assessment of the brain morphometry extracted from T1-w MRI sequence	3 months post-injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Persistent brain lesions - Volume	Volume of brain lesions measured with susceptibility MRI	3 months post-injury
Persistent brain lesions - Number	Number brain lesions measured with susceptibility MRI	3 months post-injury
Cerebral blood flow alteration	Cerebral blood flow quantified by arterial spin labelling perfusion MRI (ASL)	3 months post-injury
Functional integrity of brain networks	Functional connectivity (i.e., correlation between the activation of brain regions) measured by resting-state functional MRI	3 months post-injury
Structural integrity of brain networks	White matter micro-structure measured by diffusion MRI	3 months post-injury

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute and persistent post-concussive symptoms	Assessment of post-concussive symptoms using the REACTIONS questionnaire	Through study completion, an average of 3 months
Persistent behavioural difficulties	Assessment of behaviour using the Strengths and Difficulties Questionnaire	3 months post-injury

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Collaborators: Institut National de Recherche en Informatique et en Automatique
• Investigators: Study Director: Fanny DÉGEILH, PhD, Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Estimated): September 2, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): February 27, 2025

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: C22-48; 2022-A02619-34 (Registry Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No