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

Recruiting

• Conditions: TBI (Traumatic Brain Injury)
• Interventions: Other: IRM exam

• Registration Number: NCT06024122
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-08-28
• Study First Posted: 2023-09-06
• Study Start: 2024-07-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2026-10
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with a mTBI	IRM exam	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.
Control with an orthopaedic injury	IRM exam	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.

Primary Outcome Measures

Name	Time	Method
Persistent brain structure alterations	3 months post-injury	Quantitative assessment of the brain morphometry extracted from T1-w MRI sequence

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Unité des urgences médicochirurgicales CHU Rennes; 🇫🇷 Rennes, France