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

Posttraumatic Stress Disorder Clinical Trial

Official title:

Multi-modality Magnetic Resonance Imaging Biomarkers of Mild Traumatic Brain Injury: a Longitudinal Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02868684
• Other study ID #: NSFC81571752-1
• Status: Completed
• Start date: August 2016
• Est. completion date: September 2020

Study information

• Verified date: May 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Affective and Somatic Complaints
• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Cognitive Impairments
• Mild Traumatic Brain Injury
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Wounds and Injuries

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

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