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

NCT ID: NCT02868684

Last Updated: 2022-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2020-09-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

mild traumatic brain injury

No interventions assigned to this group

Healthy controls

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming Zhang, M.D

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 33228537 (View on PubMed)

Other Identifiers

NSFC81571752-1

Identifier Type: -

Identifier Source: org_study_id