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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02868684
Enrollment
200
Registered
2016-08-16
Start date
2016-08-31
Completion date
2020-09-30
Last updated
2022-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Second Affiliated Hospital of Wenzhou Medical University
CollaboratorOTHER
First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Correlation between brain diffusion tensor imaging measures and Posttraumatic Stress Disorder symptom1 month

Secondary

MeasureTime frame
Changes in post-concussive symptomsbaseline, 1 month
changes in affective complaintsbaseline and follow-up
Changes in somatic complaintsbaseline and follow-up

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026