Imaging of Injury Mechanism and Interaction of Intestinal Bacteria in Children With Mild Traumatic Brain Injury

Study Overview
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Brief Summary
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Traumatic brain injury (TBI) is the leading cause of disability in children and young adults. Children with moderate to severe TBI are typically at risk of poor functional outcome in terms of neurocognitive impairment and behavior problems. Neurocognitive impairments include deficits in attention and working memory, learning and memory, and executive functioning, whereas behavior problems include anxiety, depression and aggression. Neuroimaging techniques based on multi-modal magnetic resonance image (MRI) can detect the structural and functional brain abnormalities objectively and sensitively. Recent evidence indicates that even after mild TBI, children with risk factors for intracranial pathology are at risk of poor neurocognitive and behavioral outcome.Meanwhile, recently, the concept of gut-brain axis has been proposed and hint gut microbiota could shape the brain. Some studies have emphasized that human gut microbiota plays an important role in the pathogenesis and development of TBI. However, how the gut affects the brain in patients with TBI is unclear. Thus, combining analysis of neuroimaging and gut-brain axis will provide more information for finding the risk factors and imaging diagnostic markers of brain impairment in TBI. It will also helpful for explaining the underlying mechanisms of brain impairment in TBI, providing an objective basis for clinical diagnosis and prediction of the prognosis.

Official Title
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Imaging of Injury Mechanism and Interaction of Intestinal Bacteria in Children With Mild Traumatic Brain Injury

Conditions
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MTBI - Mild Traumatic Brain Injury

Intervention / Treatment
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* Device: magnetic resonance image
* Other: gut microbiota


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 6-14 years at time of recruitment. hospital admission with a clinical diagnosis of TBI for inclusion in the TBI group GCS = 15-13. loss of consciousness duration≤30 min. post-traumatic amnesia duration ≤1 h. Exclusion Criteria: previous TBI. visual or auditory disorder interfering with neurocognitive testing. current neurological condition affecting the central nervous system with known effects on neurocognitive functioning, other than TBI.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mTBI<br>A TBI is caused by a bump, blow, or jolt to the head that disrupts the normal function of the brain. Not all blows or jolts to the head result in a TBI. | Device: magnetic resonance image<br>* Imaging data were collected in a strong magnetic field<br>Other: gut microbiota<br>* gut microbiota<br>|
| HC<br>Healthy controls | Device: magnetic resonance image<br>* Imaging data were collected in a strong magnetic field<br>Other: gut microbiota<br>* gut microbiota<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline brain structure measures at 6 months and 12months | The changes of brain volume (mm3) are evaluated by structural MRI | baseline (early injury), post-traumatic for 6 months and 12 months | 
| Change from baseline brain function measures at 6 months and 12months | The changes of brain functional connectivity intensity are evaluated by functional MRI | baseline (early injury), post-traumatic for 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline cognitive condition at 6 months and 12months | The cognitive condition is assessed by Wechsler Intelligence Scale for Children-IV-Chinese Version (WISC-IV), higher scores represent better cognitive. | baseline (early injury), post-traumatic for 6 months and 12 months | 
| Changes from baseline behavior condition at 6 months and 12months | the neuro-behavior condition is assessed by child behavior checklist（CBCL），higher scores represent better behavior symptoms. | baseline (early injury), post-traumatic for 6 months and 12 months | 
| Changes from baseline gut microbiota at 6 months and 12months | Fecal samples were collected within 2 days before or after MR examination | baseline (early injury), post-traumatic for 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild Traumatic Brain Injury, MRI, gut microbiota