Imaging Biomarkers of Mild Traumatic Brain Injury: a Longitudinal Cohort Study

Completed

• Conditions: Posttraumatic Stress Disorder; Mild Traumatic Brain Injury; Affective and Somatic Complaints; Cognitive Impairments

• Registration Number: NCT02868684
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-14
• Study First Posted: 2016-08-16
• Primary Completion: 2020-08
• Study Completion: 2020-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-08
• Last Update Posted: 2022-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between brain diffusion tensor imaging measures and Posttraumatic Stress Disorder symptom	1 month

Secondary Outcome Measures

Name	Time	Method
Changes in post-concussive symptoms	baseline, 1 month
changes in affective complaints	baseline and follow-up
Changes in somatic complaints	baseline and follow-up

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China