Clinical trial NCT00478400: Awareness of Deficit After Combat-related Brain Injury
Official title: Awareness of Deficit After Combat-related Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Veterans
Keywords: Recovery
Magnetic resonance imaging
Awareness
Neurologic deficits
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Wisconsin, Madison
First posted: 2007-05-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans will be recruited through the Middleton VA Hospital in Madison, WI. Civilian participants will be recruited from a previous study led by Dr. Johnson.

Brief summary: This study will use MRI imaging, cognitive testing and outcome questionnaires to determine how the brain recovers and reorganizes after an injury.

Detailed description: The extent of recovery from brain injury is often difficult to predict because of our limited understanding of how the brain changes as it heals. New brain imaging methods may help in this regard. One imaging technique called functional magnetic resonance imaging (fMRI) has made it possible to study the brain "at work"; that is, we can see regions of the brain that are active during particular tasks such as focusing attention, making decisions, or remembering words and pictures. Another MRI method called diffusion tensor imaging provides information on the pathways between brain regions that may be altered with brain injury.

The goals of this research are to 1) determine the brain regions involved in making accurate judgments about one's abilities and disabilities after a brain injury and whether damage to these brain areas affects outcome; and 2) examine how recovery of cognitive and physical abilities relates to changes in brain function over time. In order to accomplish the first goal we will recruit Veterans who have sustained a head injury and matched control subjects. For the second goal, we are asking patients and controls who have previously participated in brain injury research with our lab to come back for another visit at three years post-injury.

Eligibility criteria: Inclusion Criteria:

* History of traumatic brain injury at least 12 months prior to enrollment
* Control Group: No history of traumatic brain injury

Exclusion Criteria:

* Claustrophobia
* Metallic or electronic implants or devices that are not MRI-safe
* Foreign metal, such as shrapnel, in the body

Primary outcomes:
measure: Cognition change at study endpoint between TBI and controls
timeFrame: Greater than 3 years post-injury
measure: Longitudinal change in white matter
timeFrame: 2 months, 1 year, and greater than 3 years post-injury
measure: Longitudinal change in whole brain morphology
timeFrame: 2 months, 1 year, and greater than 3 years post-injury
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: William S. Middleton Memorial Veterans Hospital, Madison, WI
state: Wisconsin
Study officials:
affiliation: William S. Middleton Memorial Veterans Hospital, Madison, WI
name: Sterling C Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References: