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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age36-71
SponsorInstitut National de la Santé Et de la Recherche Médicale, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Diagnosis of previous TBI (any severity, any age)

Intentional injury,

Administration of sedative drugs that can alter brain function

Complications following injury

Trial 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))

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • IRM exam

    Other intervention

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Patients with a mTBI1 intervention
Group B: Control with an orthopaedic injury1 intervention

Trial outcomes

Primary outcomes

1

Persistent brain structure alterations

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

Time frame
3 months post-injury

Secondary outcomes

1

Persistent brain lesions - Volume

Volume of brain lesions measured with susceptibility MRI

Time frame
3 months post-injury
2

Persistent brain lesions - Number

Number brain lesions measured with susceptibility MRI

Time frame
3 months post-injury
3

Cerebral blood flow alteration

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

Time frame
3 months post-injury
4

Functional integrity of brain networks

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

Time frame
3 months post-injury

Other outcomes

1

Acute and persistent post-concussive symptoms

Assessment of post-concussive symptoms using the REACTIONS questionnaire

Time frame
Through study completion, an average of 3 months
2

Persistent behavioural difficulties

Assessment of behaviour using the Strengths and Difficulties Questionnaire

Time frame
3 months post-injury

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Institut National de Recherche en Informatique et en Automatique

Collaborator