MTBI - Mild Traumatic Brain InjuryNCT05090007
Imaging of Injury Mechanism and Interaction of Intestinal Bacteria in Children With Mild Traumatic Brain Injury
An observational study of MTBI - Mild Traumatic Brain Injury, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- MTBI - Mild Traumatic Brain Injury
- What is being tested?
- magnetic resonance image and gut microbiota
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
Ming Zhang, PhD, 0086-18991232265, zmmri@163.com
Lijun Bai, PhD, 0086-15129034948, bailijun@xjtu.edu.cn
About this study
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
- Being tested
- magnetic resonance image, gut microbiota
- Keywords
- Mild Traumatic Brain Injury, MRI, gut microbiota
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imageDevice
Imaging data were collected in a strong magnetic field
gut microbiotaOther
gut microbiota
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: magnetic resonance image; Other: gut microbiota | |
| HC | Healthy controls Receives: Device: magnetic resonance image; Other: gut microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline brain structure measures at 6 months and 12months
The changes of brain volume (mm3) are evaluated by structural MRI
Measured: 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
Measured: baseline (early injury), post-traumatic for 6 months and 12 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: baseline (early injury), post-traumatic for 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start25 Oct 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MTBI - Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xi'an Jiaotong University, Second Affiliated Hospital of Wenzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Ming Zhang, Principal investigator, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090007
- Sponsor's protocol ID
- 82071993
- Status last verified
- Apr 2022
- First submitted
- 10 Oct 2021
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Injury Mechanism and Interaction of Intestinal Bacteria in Children With Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05090007
- Acronym / sponsor ID
- 82071993
- Conditions
- MTBI - Mild Traumatic Brain Injury
- Keywords
- Mild Traumatic Brain Injury, MRI, gut microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Xi'an Jiaotong University, Second Affiliated Hospital of Wenzhou Medical University
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mTBI | – | Device: magnetic resonance image, Other: gut microbiotaA 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. |
| HC | – | Device: magnetic resonance image, Other: gut microbiotaHealthy controls |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic resonance imageImaging data were collected in a strong magnetic field | Device | HC, mTBI |
| gut microbiotagut microbiota | Other | HC, mTBI |
Primary outcome
Change from baseline brain structure measures at 6 months and 12months
Time frame: baseline (early injury), post-traumatic for 6 months and 12 months
The changes of brain volume (mm3) are evaluated by structural MRI
Change from baseline brain function measures at 6 months and 12months
Time frame: baseline (early injury), post-traumatic for 6 months and 12 months
The changes of brain functional connectivity intensity are evaluated by functional MRI
3 secondary outcomes
Changes from baseline cognitive condition at 6 months and 12months
Time frame: baseline (early injury), post-traumatic for 6 months and 12 months
Changes from baseline behavior condition at 6 months and 12months
Time frame: baseline (early injury), post-traumatic for 6 months and 12 months
Changes from baseline gut microbiota at 6 months and 12months
Time frame: baseline (early injury), post-traumatic for 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Zhang principal investigator
First Affiliated Hospital of Xian Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MTBI - Mild Traumatic Brain Injury, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Zhang, phD (0086-18991232265, zmmri@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline brain structure measures at 6 months and 12months (time frame: baseline (early injury), post-traumatic for 6 months and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.