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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A02619-34 | Registry Identifier | IDRCB |
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| Name | Class |
|---|---|
| Institut National de Recherche en Informatique et en Automatique | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRM exam | Other | A non-sedated MRI scan will be performed to assess the structure and function of the children's brains |
|
| Measure | Description | Time Frame |
|---|---|---|
| Persistent brain structure alterations | Quantitative assessment of the brain morphometry extracted from T1-w MRI sequence | 3 months post-injury |
| 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 |
| 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 |
Inclusion Criteria:
Patient group with mild traumatic brain injury (mTBI) :
Control group with orthopaedic injury:
Exclusion Criteria:
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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))
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fanny DÉGEILH, PhD | Contact | +33 2 99 84 71 63 | fanny.degeilh@inserm.fr | |
| Véronique CHASLE, MD | Contact | +33 2 99 26 67 58 | veronique.chasle@chu-rennes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Fanny DÉGEILH, PhD | Institut National de la Santé Et de la Recherche Médicale, France | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unité des urgences médicochirurgicales CHU Rennes | Recruiting | Rennes | 35200 | France |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
Assessment of behaviour using the Strengths and Difficulties Questionnaire
| 3 months post-injury |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |