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Clinical Trials/NCT05090007
NCT05090007
Recruiting
Not Applicable

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

First Affiliated Hospital Xi'an Jiaotong University1 site in 1 country300 target enrollmentOctober 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
MTBI - Mild Traumatic Brain Injury
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Enrollment
300
Locations
1
Primary Endpoint
Change from baseline brain function measures at 6 months and 12months
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 25, 2021
End Date
December 31, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

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-
  • 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.

Outcomes

Primary Outcomes

Change from baseline brain function measures at 6 months and 12months

Time Frame: 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

Time Frame: baseline (early injury), post-traumatic for 6 months and 12 months

The changes of brain volume (mm3) are evaluated by structural MRI

Secondary Outcomes

  • Changes from baseline gut microbiota at 6 months and 12months(baseline (early injury), post-traumatic for 6 months and 12 months)
  • Changes from baseline cognitive condition at 6 months and 12months(baseline (early injury), post-traumatic for 6 months and 12 months)
  • Changes from baseline behavior condition at 6 months and 12months(baseline (early injury), post-traumatic for 6 months and 12 months)

Study Sites (1)

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