Posttraumatic Stress Disorder Clinical Trial
Official title:
Multi-modality Magnetic Resonance Imaging Biomarkers of Mild Traumatic Brain Injury: a Longitudinal Cohort Study
NCT number | NCT02868684 |
Other study ID # | NSFC81571752-1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | September 2020 |
Verified date | May 2022 |
Source | First Affiliated Hospital Xi'an Jiaotong University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | September 2020 |
Est. primary completion date | August 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Glasgow Coma Score of 13-15; - 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. - no contraindications to MRI; - injury within 7 days; - 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: - history of neurological disease - head injury, or history of substance or alcohol abuse, intubation and/or presence of a skull fracture - administration of sedatives on arrival in the emergency department - 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. |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital Xi'an Jiaotong University | Second Affiliated Hospital of Wenzhou Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation between brain diffusion tensor imaging measures and Posttraumatic Stress Disorder symptom | 1 month | ||
Secondary | Changes in post-concussive symptoms | baseline, 1 month | ||
Secondary | changes in affective complaints | baseline and follow-up | ||
Secondary | Changes in somatic complaints | baseline and follow-up |
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