跳至主要内容
临床试验/NCT05090007
NCT05090007招募中不适用

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

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Change from baseline brain function measures at 6 months and 12months

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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

时间窗: baseline (early injury), post-traumatic for 6 months and 12 months

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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