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

NCT02868684 | Completed DMC

• 1 other identifier: NSFC81571752-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Correlation between brain diffusion tensor imaging measures and Posttraumatic Stress Disorder symptom

  1 month

Secondary Outcomes (3)

• Changes in post-concussive symptoms

  baseline, 1 month

• changes in affective complaints

  baseline and follow-up

• Changes in somatic complaints

  baseline and follow-up

Study Arms (2)

mild traumatic brain injury

Healthy controls

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Second Affiliated Hospital of Wenzhou Medical University: collaborator

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Related Publications (1)

• 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.

  PMID: 33228537 DERIVED

MeSH Terms

Conditions

Brain Concussion; Stress Disorders, Post-Traumatic; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Ming Zhang, M.D

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 16, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: May 12, 2022

Record last verified: 2022-05

Locations

CN (1)