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Clinical Trials/NCT01196299
NCT01196299
Completed
Not Applicable

Prognostic Value of MR Imaging Markers in the Assessment of Traumatic Brain Injury Patients

University of Maryland, Baltimore1 site in 1 country150 target enrollmentMarch 21, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
University of Maryland, Baltimore
Enrollment
150
Locations
1
Primary Endpoint
Identification of advanced MR imaging markers
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 21, 2010
End Date
September 5, 2015
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rao P Gullapalli

Professor

University of Maryland, Baltimore

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • extent of disability(18 months post-injury)
  • level of orientation(18 months post-injury)
  • level of cognitive function(18 months post-injury)
  • level of functional independence(18 months post-injury)

Study Sites (1)

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