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Completed

NCT Number: NCT00478400

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cognition change at study endpoint between TBI and controls

    Time frame: Greater than 3 years post-injury

  2. Longitudinal change in white matter

    Time frame: 2 months, 1 year, and greater than 3 years post-injury

    Participants will include post-TBI in survivors the investigators have studied previously

  3. Longitudinal change in whole brain morphology

    Time frame: 2 months, 1 year, and greater than 3 years post-injury

    Participants will include post-TBI in survivors the investigators have studied previously

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • University of Wisconsin, Madison

Registry information

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
May 24, 2007
Registry last updated
Dec 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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