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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02868684
Other study ID # NSFC81571752-1
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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