Imaging of Injury Mechanism and Interaction of Intestinal Bacteria in Children With Mild Traumatic Brain Injury
- Conditions
- MTBI - Mild Traumatic Brain Injury
- Interventions
- Device: magnetic resonance imageOther: gut microbiota
- Registration Number
- NCT05090007
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description mTBI magnetic resonance image 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. HC magnetic resonance image Healthy controls HC gut microbiota Healthy controls mTBI gut microbiota 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.
- Primary Outcome Measures
Name Time Method Change from baseline brain function measures at 6 months and 12months baseline (early injury), post-traumatic for 6 months and 12 months The changes of brain functional connectivity intensity are evaluated by functional MRI
Change from baseline brain structure measures at 6 months and 12months baseline (early injury), post-traumatic for 6 months and 12 months The changes of brain volume (mm3) are evaluated by structural MRI
- Secondary Outcome Measures
Name Time Method Changes from baseline gut microbiota at 6 months and 12months baseline (early injury), post-traumatic for 6 months and 12 months Fecal samples were collected within 2 days before or after MR examination
Changes from baseline cognitive condition at 6 months and 12months baseline (early injury), post-traumatic for 6 months and 12 months The cognitive condition is assessed by Wechsler Intelligence Scale for Children-IV-Chinese Version (WISC-IV), higher scores represent better cognitive.
Changes from baseline behavior condition at 6 months and 12months baseline (early injury), post-traumatic for 6 months and 12 months the neuro-behavior condition is assessed by child behavior checklist（CBCL），higher scores represent better behavior symptoms.
Trial Locations
- Locations (1)
First Affiliated Hospital of Xian Jiaotong University
🇨🇳Xian, Shaanxi, China