Imaging of Traumatic Brain Injury

Completed

• Conditions: Traumatic Brain Injury

• Registration Number: NCT01196299
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

This project aims to study the prognostic ability of various MRI imaging markers in the evaluation of TBI patients. Cognitive, social, and occupational recovery will be measured at each time point, and compared to MRI findings. Healthy volunteers will serve as a comparison to the TBI patients.

It is hypothesized that novel MRI markers of metabolism, hemodynamics, functional connectivity, and tissue microstructure will be related to the clinical status of the patient, as well as their social and occupational outcomes.

Detailed Description

The goal of this study is to identify advanced magnetic resonance imaging markers that can serve as a prognostic marker in the evaluation and management of traumatic brain injury patients.

Magnetic resonance imaging and cognitive testing (when possible) will be performed in the acute (within 10 days following injury), and recovery stages (about 1 month, about 6 months,and about 18 months). The relationship between the advanced magnetic resonance imaging markers and the clinical condition of the patient will be evaluated at each time point to determine which combination of imaging markers best describe the current clinical status of the patient and which markers best predict a patient's outcome status.

Study Timeline

• Study Start: 2010-03-21
• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-03
• Study First Posted: 2010-09-08
• Primary Completion: 2015-04-17
• Study Completion: 2015-09-05
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Age 18 or older
• Evidence of external head injury or facial trauma, or mechanism of injury consistent with brain trauma, including loss of consciousness or altered mental status.
• Residence within 90 minutes driving time of University of Maryland Medical Center, and willingness to attend follow-up appointments.

Exclusion Criteria

• History of white matter disease or neurodegenerative disorders including Multiple Sclerosis, Huntington's Disease, Alzheimer's Disease, or Pick's Disease.
• History of Stroke
• History of treatment or diagnosis of psychiatric conditions: Major Depressive Disorder (MDD), Bipolar Disorder (BPD), Schizophrenia, or Dementia of any type.
• History of Brain Tumor
• Status post trauma due to asphyxiation
• Preexisting contraindications for Magnetic Resonance Imaging (MRI)
• Active Duty Military Status
• Police custody or prisoner status
• Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of advanced MR imaging markers	18 months post-injury	Systematically study the imaging markers obtained from novel MRI techniques (diffusion tensor imaging (DTI), susceptibility-weighted imaging (SWI), MR spectroscopy, resting state MRI, and arterial spin labeling) and assess the markers for sensitivity.

Secondary Outcome Measures

Name	Time	Method
extent of disability	18 months post-injury
level of cognitive function	18 months post-injury
level of functional independence	18 months post-injury
level of orientation	18 months post-injury

Trial Locations

Locations (1)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States