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Completed

NCT Number: NCT02868684

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

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.

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Key information

Conditions

Mild Traumatic Brain Injury Affective and Somatic Complaints Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairments Craniocerebral Trauma Head Injuries, Closed Mental Disorders Nervous System Diseases Neurocognitive Disorders Posttraumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 1 month

Secondary outcomes

  1. Changes in post-concussive symptoms

    Time frame: baseline, 1 month

  2. changes in affective complaints

    Time frame: baseline and follow-up

  3. Changes in somatic complaints

    Time frame: baseline and follow-up

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Collaborators

  • Second Affiliated Hospital of Wenzhou Medical University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 16, 2016
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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