Clinical trial NCT02868684: Imaging Biomarkers of Mild Traumatic Brain Injury: a Longitudinal Cohort Study
Official title: Multi-modality Magnetic Resonance Imaging Biomarkers of Mild Traumatic Brain Injury: a Longitudinal Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Traumatic Brain Injury
Posttraumatic Stress Disorder
Affective and Somatic Complaints
Cognitive Impairments
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Wenzhou Medical University
First posted: 2016-08-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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. Three research assistants (trained, board-certified neurologist or neurosurgeon) monitored the ED and hospital wards on a daily basis to identify new admissions. Screening for mild traumatic brain injury (TBI) was based on the World Health Organization's Collaborating Centre for Neurotrauma Task Force.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Correlation between brain diffusion tensor imaging measures and Posttraumatic Stress Disorder symptom
timeFrame: 1 month
Secondary outcomes:
measure: Changes in post-concussive symptoms
timeFrame: baseline, 1 month
measure: changes in affective complaints
timeFrame: baseline and follow-up
measure: Changes in somatic complaints
timeFrame: baseline and follow-up
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Ming Zhang, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Niu X, Bai L, Sun Y, Wang Y, Bai G, Yin B, Wang S, Gan S, Jia X, Liu H. Mild traumatic brain injury is associated with effect of inflammation on structural changes of default mode network in those developing chronic pain. J Headache Pain. 2020 Nov 23;21(1):135. doi: 10.1186/s10194-020-01201-7.