Brain InjuriesNCT06099210
The Value of Multimodal MR Imaging in Cognitive Assessment of Patients With Moderate Traumatic Brain Injury
An observational study of Brain Injuries, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The goal of this observational study is to learn about in The value of multimodal MR Imaging in cognitive assessment of patients with moderate traumatic brain injury. The main question it aims to answer is: The construction of the core injury model of cognitive impairment caused by moderate brain trauma takes… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Glasgow coma scale
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2023to 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 1. Inclusion criteria: emergency admission. Age: 18-60 years, GCS 9-12 points at presentation, time for loss of consciousness: 30 minutes-24 hours, forgetting time after injury: 1-7 days.2. Control group: in the age, gender, education level, skill and disease group matching, and no psychiatric or neurological diseases.3. Exclusion criteria: alcohol consumption within 24 hours at the time or before, and drug abuse. Previous history of brain trauma, MRI contraindication, brain penetrating injury, psychotropic drug use, spinal cord injury, positive neurological examination, multifunctional disorder, neurological and psychiatric history with significant MRI artifacts, and poor image quality.
Who may be able to join
- GCS 9-12 points
- Time for loss of consciousness: 30 minutes-24 hours
- Forget time after injury: 1-7 days
Who cannot join
- Alcohol consumption, substance abuse during or within the previous 24 hours
- Previous history of traumatic brain injury, MRI contraindication, penetrating brain injury, psychotropic substance use, spinal cord injury, positive neurological examination, multifunctional disorder
- Neurological and psychiatric history
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Zhuonan Wang, PHD, 0086-15332359525, wangzhuonan@xjtu.edu.cn
About this study
The goal of this observational study is to learn about in The value of multimodal MR Imaging in cognitive assessment of patients with moderate traumatic brain injury. The main question it aims to answer is:
- The construction of the core injury model of cognitive impairment caused by moderate brain trauma takes multi-parameter MR scanning as the main line of research, centering on the analysis of cognitive impairment of white matter structure damage and brain function involved in the research institute, and conducts research on key scientific issues such as the validity verification of cognitive prognosis after moderate brain trauma.
Participants will be collected for MR, hematology and stool and neuropsychological Scale indicators in the study.
Read the detailed description
According to the World Health Organization's (WHO) public health statistics on neurological diseases, it is expected that by 2030, neurological injuries caused by brain trauma will become the leading cause of disability of neurological diseases, and Alzheimer's disease and cerebrovascular disease combined two to three times. More than 50 million people worldwide suffer from TBI each year, and about half of the world's population may experience one or more TBI in their lifetime. As a potential risk factor, TBI will increase the risk of neurodegenerative diseases by 1.5 times, and up to 30%-70% of TBI patients will develop neurological symptoms. Brain injury is an important global medical, public health and social problem. Early diagnosis and effective treatment can effectively reduce the disability rate of patients and the incidence of neurological sequelae, which has become a hot topic in the international scientific research community. This study focuses on the construction of the core injury model of cognitive impairment caused by moderate traumatic brain injury, takes multi-parameter MR Scanning as the main line of research, and focuses on the analysis of cognitive impairment caused by white matter structure injury and brain function covariation involved in this study as the breakthrough point, and carries out research on key scientific issues such as the validity verification of cognitive prognosis after moderate traumatic brain injury.
This study was conducted mainly on moderate brain trauma, combined with related departments of neurosurgery, imaging, laboratory, rehabilitation and pain. The research objective is to collect 50 patients with brain trauma and 50 healthy control group from the First Affiliated Hospital of Xi'an Jiaotong University and Ankang Central Hospital. The magnetic resonance, hematology, stool and neuropsychology scale 3 indicators. Magnetic resonance examination: For patients with moderate craniocerebral trauma who meet the inclusion criteria, head MRI scans were performed in the subacute period after injury (within 10 to 21 days) and 3-6 months (chronic phase); for the control group with age, gender, education, skill and disease group and with no psychiatric or neurological diseases. The scanning sequence includes: (1) 3-pl (the positioning image requires the preservation of the whole brain, Including the overhead scalp to all the cerebellum) (check the parameters before scanning); (2) T2-FLAIR (brain condition prediction, If any abnormal lesion, The scan should be stopped immediately) (3) T1-weighted 3D-MPRAGE (4) DTI (5) Resting State (BOLD) (positioning line parallel to AC-PC line) (6) MAGiC (7) ASL 5. Neuropsychological evaluation: patients with moderate brain trauma before or within 48 hours after each scan; For healthy controls matched for sex, age, education, and literacy, Neuropsychological scale assessments were performed at 48 hours after completing the MRI examination. The scale includes pain after TBI, memory, executive function, information processing, TBI recovery, anxiety, and depression.6. Hematology and stool data collection: collect data of hematological markers (whole blood samples to our hospital (0 days), the first MR scan (10~21 days) and 24 hours before (3-6 months after injury) (3 mL * 2, serum samples 3 mL * 1 / time), collect stool samples (about 1mg) before the first MR scan and 24 hours before the second MR scan.
- Conditions
- Brain Injuries
- Being tested
- Glasgow coma scale
- Keywords
- moderate traumatic brain injury, MRI, axial cord injury, cognitive disorder
- Medical subject headings
- Brain Injuries, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glasgow coma scaleDiagnostic test
Closed tach brain injury due to external force was included according to the GCS score
| Study group | Role | What they receive |
|---|---|---|
| Moderate traumatic brain injury | Intervention: Glasgow coma scale Receives: Diagnostic Test: Glasgow coma scale | |
| Healthy control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
head MRI scans
The scanning sequence includes: (1) 3-pl (the positioning image requires the preservation of the whole brain, Including the overhead scalp to all the cerebellum) (check the parameters before scanning); (2) T2-FLAIR (brain condition prediction, If any abnormal lesion, The scan should be stopped immediately) (3) T1-weighted 3D-MPRAGE (4) DTI (5) Resting State (BOLD) (positioning line parallel to AC-PC line) (6) MAGiC (7) ASL
Measured: in the subacute period after injury (within 10 to 21 days) and 3-6 months (chronic phase)
Neuropsychological evaluation
The scale includes pain after TBI, memory, executive function, information processing, TBI recovery, anxiety, and depression.
Questionnaires were scored separately. Trail making test A: The score is given in time (seconds). If the test time is greater than 78 seconds, the higher the score, the worse the damage is. Rivermead Post Concussion: From 0 to 80, the higher the score may reflect the more severe the sequelae of concussion. Digit Span: From 0-12, higher scores may reflect better number breadth. Language fluency test: greater than or equal to 0 points, the higher the score, the better the language fluency. Pain score: 0-50, the higher the score reflects the higher pain. Short From Headache Impact Test: 36-78 points, higher scores reflect higher headache degree. Fatigue Severity Scale: 1-7, and higher scores reflect greater fatigue. Mini-mental State Examination: Less than or equal to 22 is dementia, and less than or equal to 15 is severe dementia.
Measured: patients with moderate brain trauma before or within 48 hours after each scan; For healthy controls matched for sex, age, education, and literacy, Neuropsychological scale assessments were performed at 48 hours after completing the MRI examination.
Hematology and stool data
collect data of hematological markers (whole blood samples to our hospital (0 days), the first MR scan (10~21 days) and 24 hours before (3-6 months after injury) (3 mL * 2, serum samples 3 mL * 1 / time), collect stool samples (about 1mg) before the first MR scan and 24 hours before the second MR scan.
Measured: hematological markers (whole blood samples (0 days), the first MR scan (10~21 days) and 24 hours before (3-6 months after injury), stool samples before the first MR scan and 24 hours before the second MR scan.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start3 Jul 2023
- 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 Brain InjuriesStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ankang Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099210
- Sponsor's protocol ID
- XJTU1AF2023LSK-194
- Status last verified
- Mar 2024
- First submitted
- 19 Oct 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Multimodal MR Imaging in Cognitive Assessment of Patients With Moderate Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06099210
- Acronym / sponsor ID
- XJTU1AF2023LSK-194
- Conditions
- Brain Injuries
- Keywords
- moderate traumatic brain injury, MRI, axial cord injury, cognitive disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Ankang Central Hospital
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Oct 2023 (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.
The goal of this observational study is to learn about in The value of multimodal MR Imaging in cognitive assessment of patients with moderate traumatic brain injury. The main question it aims to answer is:
- The construction of the core injury model of cognitive impairment caused by moderate brain trauma takes multi-parameter MR scanning as the main line of research, centering on the analysis of cognitive impairment of white matter structure damage and brain function involved in the research institute, and conducts research on key scientific issues such as the validity verification of cognitive prognosis after moderate brain trauma.
Participants will be collected for MR, hematology and stool and neuropsychological Scale indicators in the study.
Detailed description
According to the World Health Organization's (WHO) public health statistics on neurological diseases, it is expected that by 2030, neurological injuries caused by brain trauma will become the leading cause of disability of neurological diseases, and Alzheimer's disease and cerebrovascular disease combined two to three times. More than 50 million people worldwide suffer from TBI each year, and about half of the world's population may experience one or more TBI in their lifetime. As a potential risk factor, TBI will increase the risk of neurodegenerative diseases by 1.5 times, and up to 30%-70% of TBI patients will develop neurological symptoms. Brain injury is an important global medical, public health and social problem. Early diagnosis and effective treatment can effectively reduce the disability rate of patients and the incidence of neurological sequelae, which has become a hot topic in the international scientific research community. This study focuses on the construction of the core injury model of cognitive impairment caused by moderate traumatic brain injury, takes multi-parameter MR Scanning as the main line of research, and focuses on the analysis of cognitive impairment caused by white matter structure injury and brain function covariation involved in this study as the breakthrough point, and carries out research on key scientific issues such as the validity verification of cognitive prognosis after moderate traumatic brain injury.
This study was conducted mainly on moderate brain trauma, combined with related departments of neurosurgery, imaging, laboratory, rehabilitation and pain. The research objective is to collect 50 patients with brain trauma and 50 healthy control group from the First Affiliated Hospital of Xi'an Jiaotong University and Ankang Central Hospital. The magnetic resonance, hematology, stool and neuropsychology scale 3 indicators. Magnetic resonance examination: For patients with moderate craniocerebral trauma who meet the inclusion criteria, head MRI scans were performed in the subacute period after injury (within 10 to 21 days) and 3-6 months (chronic phase); for the control group with age, gender, education, skill and disease group and with no psychiatric or neurological diseases. The scanning sequence includes: (1) 3-pl (the positioning image requires the preservation of the whole brain, Including the overhead scalp to all the cerebellum) (check the parameters before scanning); (2) T2-FLAIR (brain condition prediction, If any abnormal lesion, The scan should be stopped immediately) (3) T1-weighted 3D-MPRAGE (4) DTI (5) Resting State (BOLD) (positioning line parallel to AC-PC line) (6) MAGiC (7) ASL 5. Neuropsychological evaluation: patients with moderate brain trauma before or within 48 hours after each scan; For healthy controls matched for sex, age, education, and literacy, Neuropsychological scale assessments were performed at 48 hours after completing the MRI examination. The scale includes pain after TBI, memory, executive function, information processing, TBI recovery, anxiety, and depression.6. Hematology and stool data collection: collect data of hematological markers (whole blood samples to our hospital (0 days), the first MR scan (10~21 days) and 24 hours before (3-6 months after injury) (3 mL * 2, serum samples 3 mL * 1 / time), collect stool samples (about 1mg) before the first MR scan and 24 hours before the second MR scan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate traumatic brain injury | – | Diagnostic Test: Glasgow coma scaleIntervention: Glasgow coma scale |
| Healthy control group | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 1. Inclusion criteria: emergency admission. Age: 18-60 years, GCS 9-12 points at presentation, time for loss of consciousness: 30 minutes-24 hours, forgetting time after injury: 1-7 days.2. Control group: in the age, gender, education level, skill and disease group matching, and no psychiatric or neurological diseases.3. Exclusion criteria: alcohol consumption within 24 hours at the time or before, and drug abuse. Previous history of brain trauma, MRI contraindication, brain penetrating injury, psychotropic drug use, spinal cord injury, positive neurological examination, multifunctional disorder, neurological and psychiatric history with significant MRI artifacts, and poor image quality.
Key inclusion criteria (3 listed)
- GCS 9-12 points
- Time for loss of consciousness: 30 minutes-24 hours
- Forget time after injury: 1-7 days
Key exclusion criteria (3 listed)
- Alcohol consumption, substance abuse during or within the previous 24 hours
- Previous history of traumatic brain injury, MRI contraindication, penetrating brain injury, psychotropic substance use, spinal cord injury, positive neurological examination, multifunctional disorder
- Neurological and psychiatric history
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 |
|---|---|---|
| Glasgow coma scaleClosed tach brain injury due to external force was included according to the GCS score | Diagnostic test | Moderate traumatic brain injury |
Primary outcome
head MRI scans
Time frame: in the subacute period after injury (within 10 to 21 days) and 3-6 months (chronic phase)
The scanning sequence includes: (1) 3-pl (the positioning image requires the preservation of the whole brain, Including the overhead scalp to all the cerebellum) (check the parameters before scanning); (2) T2-FLAIR (brain condition prediction, If any abnormal lesion, The scan should be stopped immediately) (3) T1-weighted 3D-MPRAGE (4) DTI (5) Resting State (BOLD) (positioning line parallel to AC-PC line) (6) MAGiC (7) ASL
Neuropsychological evaluation
Time frame: patients with moderate brain trauma before or within 48 hours after each scan; For healthy controls matched for sex, age, education, and literacy, Neuropsychological scale assessments were performed at 48 hours after completing the MRI examination.
The scale includes pain after TBI, memory, executive function, information processing, TBI recovery, anxiety, and depression. Questionnaires were scored separately. Trail making test A: The score is given in time (seconds). If the test time is greater than 78 seconds, the higher the score, the worse the damage is. Rivermead Post Concussion: From 0 to 80, the higher the score may reflect the more severe the sequelae of concussion. Digit Span: From 0-12, higher scores may reflect better number breadth. Language fluency test: greater than or equal to 0 points, the higher the score, the better the language fluency. Pain score: 0-50, the higher the score reflects the higher pain. Short From Headache Impact Test: 36-78 points, higher scores reflect higher headache degree. Fatigue Severity Scale: 1-7, and higher scores reflect greater fatigue. Mini-mental State Examination: Less than or equal to 22 is dementia, and less than or equal to 15 is severe dementia.
Hematology and stool data
Time frame: hematological markers (whole blood samples (0 days), the first MR scan (10~21 days) and 24 hours before (3-6 months after injury), stool samples before the first MR scan and 24 hours before the second MR scan.)
collect data of hematological markers (whole blood samples to our hospital (0 days), the first MR scan (10~21 days) and 24 hours before (3-6 months after injury) (3 mL * 2, serum samples 3 mL * 1 / time), collect stool samples (about 1mg) before the first MR scan and 24 hours before the second MR scan.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No
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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.
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 Brain Injuries, 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 3 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 7 Mar 2024. 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 Zhuonan Wang, PHD (15332359525, wangzhuonan@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
head MRI scans (time frame: in the subacute period after injury (within 10 to 21 days) and 3-6 months (chronic phase)). The study lists 3 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 7 Mar 2024.