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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • William S. Middleton Memorial Veterans Hospital, Madison, WI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Participants who have had a TBI; (recruited by invitation only); Must be between 1- and 6-years post-injury; Closed head injury; Evidence of loss of consciousness; Must have an informant (friend, spouse, child etc.); Audit-C < 7, PCL < 65 and PHQ-9 < 15
Participants with No history of TBI; (Recruited by invitation only); No history of TBI; Must have an informant (friend, spouse, child etc.)
Veterans with History of TBI; Must be between 1- and 6-years post-injury; Closed head injury; Evidence of loss of consciousness; Must have an informant (friend, spouse, child etc.); Audit-C < 7, PCL < 65 and PHQ-9 < 15
US Veterans with No history of TBI; No history of TBI; Must have an informant (friend, spouse, child etc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognition change at study endpoint between TBI and controls		Greater than 3 years post-injury
Longitudinal change in white matter	Participants will include post-TBI in survivors the investigators have studied previously	2 months, 1 year, and greater than 3 years post-injury
Longitudinal change in whole brain morphology	Participants will include post-TBI in survivors the investigators have studied previously	2 months, 1 year, and greater than 3 years post-injury

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: University of Wisconsin, Madison
• Investigators: Principal Investigator: Sterling C Johnson, PhD, William S. Middleton Memorial Veterans Hospital, Madison, WI

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2007
• Primary Completion (Actual): October 31, 2016
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: May 22, 2007
• First Submitted That Met QC Criteria: May 22, 2007
• First Posted (Estimate): May 24, 2007

Study Record Updates

• Last Update Posted (Actual): December 22, 2017
• Last Update Submitted That Met QC Criteria: December 21, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Recovery; Magnetic resonance imaging; Awareness; Neurologic deficits
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: NEUC-029-06S; H-2006-0256 (Other Grant/Funding Number: University of Wisconsin, Madison)