Imaging of Traumatic Brain Injury (Imaging of TBI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Maryland.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT01196299
First received: September 3, 2010
Last updated: September 21, 2010
Last verified: September 2010

September 3, 2010
September 21, 2010
March 2009
June 2012   (final data collection date for primary outcome measure)
Identification of advanced MR imaging markers [ Time Frame: 18 months post-injury ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01196299 on ClinicalTrials.gov Archive Site
  • level of cognitive function [ Time Frame: 18 months post-injury ] [ Designated as safety issue: No ]
  • extent of disability [ Time Frame: 18 months post-injury ] [ Designated as safety issue: No ]
  • level of orientation [ Time Frame: 18 months post-injury ] [ Designated as safety issue: No ]
  • level of functional independence [ Time Frame: 18 months post-injury ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Imaging of Traumatic Brain Injury
Prognostic Value of MR Imaging Markers in the Assessment of Traumatic Brain Injury Patients

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients admitted with head trauma ranging from mild to severe.

Traumatic Brain Injury
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
June 2013
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Rao P Gullapalli, PhD 4103282099 rgullapalli@umm.edu
United States
 
NCT01196299
HP-00040713, W81XWH-08-1-0725
No
Rao P Gullapalli, University of Maryland, Baltimore
University of Maryland
Not Provided
Principal Investigator: Rao P Gullapalli, PhD University of Maryland Medical School
University of Maryland
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP