Awareness of Deficit After Combat-related Brain Injury

NCT ID: NCT00478400

Last Updated: 2017-12-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-10-01
• Study Completion Date: 2016-10-31

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.

Conditions

Traumatic Brain Injury; Veterans

Keywords

Recovery; Magnetic resonance imaging; Awareness; Neurologic deficits

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

No interventions assigned to this group

Participants with No history of TBI

(Recruited by invitation only)

1. No history of TBI

2. Must have an informant (friend, spouse, child etc.)

No interventions assigned to this group

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

No interventions assigned to this group

US Veterans with No history of TBI

1. No history of TBI

2. Must have an informant (friend, spouse, child etc.)

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sterling C Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

William S. Middleton Memorial Veterans Hospital, Madison, WI

Locations

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

H-2006-0256

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NEUC-029-06S

Identifier Type: -

Identifier Source: org_study_id