Imaging of Traumatic Brain Injury (Imaging of TBI)
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|ClinicalTrials.gov Identifier: NCT01196299|
Recruitment Status : Completed
First Posted : September 8, 2010
Last Update Posted : January 25, 2018
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.
|Condition or disease|
|Traumatic Brain Injury|
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 Type :||Observational|
|Actual Enrollment :||150 participants|
|Official Title:||Prognostic Value of MR Imaging Markers in the Assessment of Traumatic Brain Injury Patients|
|Actual Study Start Date :||March 21, 2010|
|Actual Primary Completion Date :||April 17, 2015|
|Actual Study Completion Date :||September 5, 2015|
Severe Traumatic Brain Injury Group
The severe traumatic brain injury group are patients admitted to the study with an admission GCS between 3 and 8.
Moderate Head Injury Group
The moderate head injury group are patients admitted to the study with an admission GCS from 9 to 12.
Mild Head Injury Group
The mild head injury group are patients admitted to the study with an admission GCS from 13 to 15.
Healthy Volunteer Group
Healthy volunteers will be selected to match the age distribution of the TBI groups. They must be absent of any abnormal radiological findings.
- Identification of advanced MR imaging markers [ Time Frame: 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.
- level of cognitive function [ Time Frame: 18 months post-injury ]
- extent of disability [ Time Frame: 18 months post-injury ]
- level of orientation [ Time Frame: 18 months post-injury ]
- level of functional independence [ Time Frame: 18 months post-injury ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196299
|United States, Maryland|
|University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Rao P Gullapalli, PhD||University of Maryland Medical School|