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
  Purpose

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


Condition
Traumatic Brain Injury
Veterans

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Awareness of Deficit After Combat-related Brain Injury

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Estimated Enrollment: 100
Study Start Date: October 2007
Estimated Study Completion Date: September 2010
Groups/Cohorts
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.)

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478400

Contacts
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

Locations
United States, Wisconsin
University of Wisconsin - Wisconsin Comprehensive Memory Program Recruiting
Madison, Wisconsin, United States, 53792
Contact: Tamara S Markgraf, MBA    866-636-7764    memory-research@medicine.wisc.edu   
Principal Investigator: Sanjay Asthana, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Sterling C Johnson, PhD University of Wisconsin/VA GRECC
  More Information

Additional Information:
No publications provided

Responsible Party: Sterling Johnson, PhD, University of Wisconsin - Madison
ClinicalTrials.gov Identifier: NCT00478400     History of Changes
Other Study ID Numbers: 2006-0256, 2006-0256
Study First Received: May 22, 2007
Last Updated: September 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Recovery
Magnetic resonance imaging
Awareness
Neurologic deficits

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

ClinicalTrials.gov processed this record on August 01, 2014