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

Xi'an Jiaotong University

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT02868684

NSFC81571752-1

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

mild traumatic brain injury

Healthy controls