Awareness of Deficit After Combat-related Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Awareness of Deficit After Combat-related Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478400
• Other study ID #: NEUC-029-06S
• Secondary ID: H-2006-0256
• Status: Completed
• Phase: N/A
• First received: May 22, 2007
• Last updated: December 21, 2017
• Start date: October 1, 2007
• Est. completion date: October 31, 2016

Study information

• Verified date: December 2017
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 31, 2016
• Est. primary completion date: October 31, 2016
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Veterans
• Wounds and Injuries

Locations

Country	Name	City	State
United States	William S. Middleton Memorial Veterans Hospital, Madison, WI	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognition change at study endpoint between TBI and controls		Greater than 3 years post-injury
Primary	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
Primary	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