Awareness of Deficit After Combat-related Brain Injury

Completed

• Conditions: Veterans; Traumatic Brain Injury

• Registration Number: NCT00478400
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2007-05-22
• Study First Submitted QC: 2007-05-22
• Study First Posted: 2007-05-24
• Study Start: 2007-10-01
• Primary Completion: 2016-10-31
• Study Completion: 2016-10-31
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-21
• Last Update Posted: 2017-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

William S. Middleton Memorial Veterans Hospital, Madison, WI; 🇺🇸 Madison, Wisconsin, United States