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Awareness of Deficit After Combat-related Brain Injury

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ClinicalTrials.gov Identifier: NCT00478400
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
VA Office of Research and Development

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

Condition or disease
Traumatic Brain Injury Veterans

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.


Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Awareness of Deficit After Combat-related Brain Injury
Actual Study Start Date : October 1, 2007
Primary Completion Date : October 31, 2016
Study Completion Date : October 31, 2016

Group/Cohort
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.)



Primary Outcome Measures :
  1. Cognition change at study endpoint between TBI and controls [ Time Frame: Greater than 3 years post-injury ]
  2. Longitudinal change in white matter [ Time Frame: 2 months, 1 year, and greater than 3 years post-injury ]
    Participants will include post-TBI in survivors the investigators have studied previously

  3. Longitudinal change in whole brain morphology [ Time Frame: 2 months, 1 year, and greater than 3 years post-injury ]
    Participants will include post-TBI in survivors the investigators have studied previously



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478400


Locations
United States, Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
VA Office of Research and Development
University of Wisconsin, Madison
Investigators
Principal Investigator: Sterling C Johnson, PhD William S. Middleton Memorial Veterans Hospital, Madison, WI

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00478400     History of Changes
Other Study ID Numbers: NEUC-029-06S
H-2006-0256 ( Other Grant/Funding Number: University of Wisconsin, Madison )
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017

Keywords provided by VA Office of Research and Development:
Recovery
Magnetic resonance imaging
Awareness
Neurologic deficits

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System