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Imaging of Traumatic Brain Injury (Imaging of TBI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by University of Maryland.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01196299
First Posted: September 8, 2010
Last Update Posted: September 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Maryland
  Purpose

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
Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Value of MR Imaging Markers in the Assessment of Traumatic Brain Injury Patients

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: March 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted with head trauma ranging from mild to severe.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Rao P Gullapalli, PhD 4103282099 rgullapalli@umm.edu

Locations
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Rao P Gullapalli, PhD         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Rao P Gullapalli, PhD University of Maryland Medical School
  More Information

Responsible Party: Rao P Gullapalli, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT01196299     History of Changes
Other Study ID Numbers: HP-00040713
W81XWH-08-1-0725 ( Other Grant/Funding Number: USA Med Research and Materiel Command )
First Submitted: September 3, 2010
First Posted: September 8, 2010
Last Update Posted: September 23, 2010
Last Verified: September 2010

Keywords provided by University of Maryland:
diffusion tensor imaging
magnetic resonance spectroscopy
traumatic brain injury
Metabolite changes
Cerebral perfusion
Hemorrhagic burden

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System