Service Member Fatigue and Lack of Motivation Following Concussion
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01496586|
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : May 17, 2018
- Many service members have reported feeling tired, a loss of motivation, mood changes, and problems working with others after they have a concussion during deployment. These problems may lead to problems with their job and relationships. This study hopes to figure out what parts of the brain may be affected in people with these problems after a concussion.
- To learn more about the problems that may occur after service members have a concussion during deployment and return home.
- Service members or veterans between 18 and 40 years of age who have had a mild traumatic brain injury (concussion) in the past 6 months.
- Companions (at least 18 years of age) of the service members will also be included in this study. Companions will have interacted with the service member at least 1 hour a week since deployment.
- Service members will have 1 week of tests at the National Institutes of Health Clinical Center. Companions will have 2 days of tests at the Center.
- Each day, service members will have 4 or 8 hours of tests. Tests will include a medical history and physical exam, neuropsychological tests and imaging studies. The tests will ask about fatigue, stress, mood, pain, daily activities, and family support. The imaging studies will measure brain function at rest and during activity.
- Companions will have a medical history and physical exam. They will also complete several questionnaires about themselves as well as the service member/veteran. The tests will ask about fatigue, stress, mood, pain, daily activities, and family support.
|Condition or disease|
|Fatigue Traumatic Brain Injury|
Objective: The primary objective of this study is to determine the behavioral-anatomical relationships that underlie fatigue and amotivation following mild traumatic brain injury in deployed military service members. The specific aims are to 1) determine the neural correlates of fatigue, and 2) assess how fatigue and social cognition relate to social outcomes including employment, community integration and participation in social activities. The theory we will test is that fatigue in this population is the result of subtle changes in frontal cortical and subcortical structures.
Study Design: Observational, natural history study.
Populations: 1) Individuals who have sustained a mild traumatic brain injury as a service member deployed in support of Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn, and who continue to experience symptoms more than 6 months after injury, and 2) Companions of individuals from the first group.
Outcome Measures: We will seek statistical associations between fatigue measures and brain morphometric and white matter diffusion measurements obtained by MRI as well as task and resting state fMRI.
|Study Type :||Observational|
|Actual Enrollment :||45 participants|
|Official Title:||Fatigue and Amotivation Following Mild Traumatic Brain Injury and Their Influence on Service Member Community Reintegration|
|Study Start Date :||December 1, 2011|
|Study Completion Date :||August 3, 2015|
- Correlations between fractional anisotropy, effective connectivity measured by size of cortical and subcortical structures on DTI, and VBM that correlate with measures of fatigue, apathy, effort expenditure. [ Time Frame: One year ]
- Correlations between fractional anisotropy, effective connectivity measured by size of cortical and subcortical structures on DTI, and VBM that correlate with measures of alexithymia and perceived stress [ Time Frame: One year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496586
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Eric M Wassermann, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|