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

NCT05090007 | Unknown

• 1 other identifier: 82071993
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

MTBI - Mild Traumatic Brain Injury

Keywords

Mild Traumatic Brain Injury, MRI, gut microbiota

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

• Changes from baseline gut microbiota at 6 months and 12months

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

Study Arms (2)

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; Other: gut microbiota

HC

Healthy controls

Device: magnetic resonance image; Other: gut microbiota

Interventions

magnetic resonance image DEVICE

Imaging data were collected in a strong magnetic field

HC; mTBI

gut microbiota OTHER

gut microbiota

HC; mTBI

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• age 6-14 years at time of recruitment.
• GCS = 15-13.
• loss of consciousness duration≤30 min.
• post-traumatic amnesia duration ≤1 h.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Xi'an Jiaotong University: collaborator
• The Second Affiliated Hospital and Yuying Childern's Hospital of Wenzhou Medical University: collaborator

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

gut microbiota

MeSH Terms

Conditions

Brain Concussion

Interventions

Magnetic Resonance Imaging; Gastrointestinal Microbiome

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Microbiota; Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Officials

• Ming Zhang

  First Affiliated Hospital of Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Zhang, phD

CONTACT

0086-18991232265; zmmri@163.com

LiJun Bai, phD

CONTACT

0086-15129034948; bailijun@xjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: October 22, 2021
• Study Start: October 25, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 10, 2022

Record last verified: 2022-04

Locations

CN (1)