Imaging Biomarkers of Mild Traumatic Brain Injury: a Longitudinal Cohort Study
Study Details
Study Description
Brief Summary
This longitudinal cohort study aims to detect the topographical nature of the white matter microstructure and resting state functional connectivity patterns across the whole brain in the evolution of pathology as a function of time following mild TBI. All consecutively patients with the non-contrast head CT because of acute head trauma from the local emergency department (ED) formed the initial population of this study. Age, sex, education-level matched healthy controls will also be enrolled. The initial scan will performed within 7 days post-injury. Clinical assessment was performed within 24 hours of MR imaging and included a broad neuropsychological and symptom assessments. Follow-up examination will conduct at 1 month, 3 month, 6-12 months.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| mild traumatic brain injury
|
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| Healthy controls
|
Outcome Measures
Primary Outcome Measures
- Correlation between brain diffusion tensor imaging measures and Posttraumatic Stress Disorder symptom [1 month]
Secondary Outcome Measures
- Changes in post-concussive symptoms [baseline, 1 month]
- changes in affective complaints [baseline and follow-up]
- Changes in somatic complaints [baseline and follow-up]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Glasgow Coma Score of 13-15;
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one or more of the following: loss of consciousness (if present) < 30 min, post-traumatic amnesia (if present) < 24 h, and/or other transient neurological abnormalities such as focal signs, seizure, and intracranial lesion not requiring surgery.
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no contraindications to MRI;
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injury within 7 days;
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agreement to communicate by telephone or e-mail for 1, 3 to 6-12 months after enrollment and come back to the hospital for follow-up
Exclusion Criteria:
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history of neurological disease
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head injury, or history of substance or alcohol abuse, intubation and/or presence of a skull fracture
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administration of sedatives on arrival in the emergency department
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spinal cord injury, manifestation of mild TBI due to other injuries (e.g., systemic injuries, facial injuries, or intubation) or other problems (e.g., psychological trauma, language barrier, or coexisting medical conditions), or caused by penetrating craniocerebral injury.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | China | 710061 |
Sponsors and Collaborators
- First Affiliated Hospital Xi'an Jiaotong University
- Second Affiliated Hospital of Wenzhou Medical University
Investigators
- Principal Investigator: Ming Zhang, M.D, First Affiliated Hospital Xi'an Jiaotong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NSFC81571752-1