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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05090007
Enrollment
300
Registered
2021-10-22
Start date
2021-10-25
Completion date
2024-12-31
Last updated
2022-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MTBI - Mild Traumatic Brain Injury

Keywords

Mild Traumatic Brain Injury, MRI, gut microbiota

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.

Interventions

Imaging data were collected in a strong magnetic field

OTHERgut microbiota

gut microbiota

Sponsors

Xi'an Jiaotong University
CollaboratorOTHER
The Second Affiliated Hospital and Yuying Childern's Hospital of Wenzhou Medical University
CollaboratorUNKNOWN
First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline brain structure measures at 6 months and 12monthsbaseline (early injury), post-traumatic for 6 months and 12 monthsThe changes of brain volume (mm3) are evaluated by structural MRI
Change from baseline brain function measures at 6 months and 12monthsbaseline (early injury), post-traumatic for 6 months and 12 monthsThe changes of brain functional connectivity intensity are evaluated by functional MRI

Secondary

MeasureTime frameDescription
Changes from baseline cognitive condition at 6 months and 12monthsbaseline (early injury), post-traumatic for 6 months and 12 monthsThe cognitive condition is assessed by Wechsler Intelligence Scale for Children-IV-Chinese Version (WISC-IV), higher scores represent better cognitive.
Changes from baseline behavior condition at 6 months and 12monthsbaseline (early injury), post-traumatic for 6 months and 12 monthsthe neuro-behavior condition is assessed by child behavior checklist(CBCL),higher scores represent better behavior symptoms.
Changes from baseline gut microbiota at 6 months and 12monthsbaseline (early injury), post-traumatic for 6 months and 12 monthsFecal samples were collected within 2 days before or after MR examination

Countries

China

Contacts

Primary ContactMing Zhang, phD
zmmri@163.com0086-18991232265
Backup ContactLiJun Bai, phD
bailijun@xjtu.edu.cn0086-15129034948

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026