KAOUENN: Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Persistent brain structure alterations [3 months post-injury]
Quantitative assessment of the brain morphometry extracted from T1-w MRI sequence
Secondary Outcome Measures
- 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)
- 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
Other Outcome Measures
- Acute and persistent post-concussive symptoms [Through study completion, an average of 3 months]
Assessment of post-concussive symptoms using the REACTIONS questionnaire
- Persistent behavioural difficulties [3 months post-injury]
Assessment of behaviour using the Strengths and Difficulties Questionnaire
Eligibility Criteria
Criteria
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
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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:
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Diagnosis of previous TBI (any severity, any age)
-
Intentional injury,
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Administration of sedative drugs that can alter brain function
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Complications following injury
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MRI contraindication,
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Parent non-fluent in French,
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Prematurity,
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Diagnosis of a severe neurological, developmental, or psychiatric disorder
-
Children in foster care at the time of recruitment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Unité des urgences médicochirurgicales CHU Rennes | Rennes | France | 35200 |
Sponsors and Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- C22-48
- 2022-A02619-34