Clinical trial NCT05090007: Imaging of Injury Mechanism and Interaction of Intestinal Bacteria in Children With Mild Traumatic Brain Injury
Official title: Imaging of Injury Mechanism and Interaction of Intestinal Bacteria in Children With Mild Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: MTBI - Mild Traumatic Brain Injury
Keywords: Mild Traumatic Brain Injury, MRI, gut microbiota
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Xi'an Jiaotong University
name: The Second Affiliated Hospital and Yuying Childern's Hospital of Wenzhou Medical University
First posted: 2021-10-22
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All of the patients of mTBI group are in-patients and out-patients in the nephrology department from three research centers. The subjects of control group are recruited from community.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline brain structure measures at 6 months and 12months
timeFrame: baseline (early injury), post-traumatic for 6 months and 12 months
measure: Change from baseline brain function measures at 6 months and 12months
timeFrame: baseline (early injury), post-traumatic for 6 months and 12 months
Secondary outcomes:
measure: Changes from baseline cognitive condition at 6 months and 12months
timeFrame: baseline (early injury), post-traumatic for 6 months and 12 months
measure: Changes from baseline behavior condition at 6 months and 12months
timeFrame: baseline (early injury), post-traumatic for 6 months and 12 months
measure: Changes from baseline gut microbiota at 6 months and 12months
timeFrame: baseline (early injury), post-traumatic for 6 months and 12 months
Other outcomes:
Locations:
city: Xian
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: Ming Zhang
role: PRINCIPAL_INVESTIGATOR
References: