Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Awareness of Deficit After Combat-related Brain Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00478400
First received: May 22, 2007
Last updated: September 27, 2010
Last verified: September 2010

May 22, 2007
September 27, 2010
October 2007
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00478400 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Awareness of Deficit After Combat-related Brain Injury
Awareness of Deficit After Combat-related Brain Injury

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

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

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.

  • Traumatic Brain Injury
  • Veterans
Not Provided
  • Participants who have had a TBI

    (recruited by invitation only)

    1. Must be between 1- and 6-years post-injury
    2. Closed head injury
    3. Evidence of loss of consciousness
    4. Must have an informant (friend, spouse, child etc.)
    5. Audit-C < 7, PCL < 65 and PHQ-9 < 15
  • Participants with No history of TBI

    (Recruited by invitation only)

    1. No history of TBI
    2. Must have an informant (friend, spouse, child etc.)
  • Veterans with History of TBI
    1. Must be between 1- and 6-years post-injury
    2. Closed head injury
    3. Evidence of loss of consciousness
    4. Must have an informant (friend, spouse, child etc.)
    5. Audit-C < 7, PCL < 65 and PHQ-9 < 15
  • US Veterans with No history of TBI
    1. No history of TBI
    2. Must have an informant (friend, spouse, child etc.)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
September 2010
Not Provided

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
Both
18 Years to 55 Years
Yes
Contact: Amy Hawley, BA 608-256-1901 ext 11418 fmri@medicine.wisc.edu
Contact: Sandy Harding, MS 608-256-1901 ext 11075 fmri@medicine.wisc.edu
United States
 
NCT00478400
2006-0256, 2006-0256
Yes
Sterling Johnson, PhD, University of Wisconsin - Madison
University of Wisconsin, Madison
Department of Veterans Affairs
Principal Investigator: Sterling C Johnson, PhD University of Wisconsin/VA GRECC
University of Wisconsin, Madison
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP