Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2010-03-21
2015-09-05
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Moderate Head Injury Group
The moderate head injury group are patients admitted to the study with an admission GCS from 9 to 12.
No interventions assigned to this group
Mild Head Injury Group
The mild head injury group are patients admitted to the study with an admission GCS from 13 to 15.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Rao P Gullapalli
Professor
Principal Investigators
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Rao P Gullapalli, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland Medical School
Locations
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University of Maryland Medical Center
Baltimore, Maryland, United States
Countries
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Other Identifiers
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W81XWH-08-1-0725
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HP-00040713
Identifier Type: -
Identifier Source: org_study_id
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