The Value of Multimodal MR Imaging in Cognitive Assessment of Patients With Moderate Traumatic Brain Injury

NCT06099210 | Recruiting

• 1 other identifier: XJTU1AF2023LSK-194
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Brain Injuries

Keywords

moderate traumatic brain injury; MRI; axial cord injury; cognitive disorder

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  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.)

Study Arms (2)

Moderate traumatic brain injury

Intervention: Glasgow coma scale

Diagnostic Test: Glasgow coma scale

Healthy control group

Interventions

Glasgow coma scale DIAGNOSTIC_TEST

Closed tach brain injury due to external force was included according to the GCS score

Moderate traumatic brain injury

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• GCS 9-12 points
• Time for loss of consciousness: 30 minutes-24 hours
• Forget time after injury: 1-7 days

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Ankang Central Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Zhuonan Wang, PHD

CONTACT

15332359525; wangzhuonan@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 19, 2023
• First Posted: October 25, 2023
• Study Start: July 3, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)