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

MTBI - Mild Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05090007
• Other study ID #: 82071993
• Status: Recruiting
• Start date: October 25, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Ming Zhang, phD
• Phone: 0086-18991232265
• Email: zmmri[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• MTBI - Mild Traumatic Brain Injury
• Wounds and Injuries

Intervention

Device:
• magnetic resonance image
Imaging data were collected in a strong magnetic field

Other:
• gut microbiota
gut microbiota

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiaotong University	Xian	Shaanxi

Sponsors (3)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	School of Life Science and Technology, Xi'an Jiaotong University, The Second Affiliated Hospital and Yuying Childern's Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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