Clinical trial NCT01196299: Imaging of Traumatic Brain Injury
Official title: Prognostic Value of MR Imaging Markers in the Assessment of Traumatic Brain Injury Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: diffusion tensor imaging
magnetic resonance spectroscopy
traumatic brain injury
Metabolite changes
Cerebral perfusion
Hemorrhagic burden
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2010-09-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted with head trauma ranging from mild to severe.

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.

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

Primary outcomes:
measure: Identification of advanced MR imaging markers
timeFrame: 18 months post-injury
Secondary outcomes:
measure: level of cognitive function
timeFrame: 18 months post-injury
measure: extent of disability
timeFrame: 18 months post-injury
measure: level of orientation
timeFrame: 18 months post-injury
measure: level of functional independence
timeFrame: 18 months post-injury
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland Medical School
name: Rao P Gullapalli, PhD
role: PRINCIPAL_INVESTIGATOR
References: