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

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.

Study Overview

• Status: Recruiting
• Conditions: MTBI - Mild Traumatic Brain Injury
• Intervention / Treatment: Device: magnetic resonance image; Other: gut microbiota

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xian, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xian Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HC; Healthy controls	Device: magnetic resonance image; Imaging data were collected in a strong magnetic field; Other: gut microbiota; gut microbiota
mTBI; 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; Imaging data were collected in a strong magnetic field; Other: gut microbiota; gut microbiota

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Health Science Center of Xi'an Jiaotong University; The Second Affiliated Hospital and Yuying Childern's Hospital of Wenzhou Medical University
• Investigators: Principal Investigator: Ming Zhang, First Affiliated Hospital of Xian Jiaotong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 25, 2021
• Primary Completion (ANTICIPATED): December 31, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: October 10, 2021
• First Submitted That Met QC Criteria: October 10, 2021
• First Posted (ACTUAL): October 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Mild Traumatic Brain Injury, MRI, gut microbiota
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 82071993

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No