Service Member Fatigue and Lack of Motivation Following Concussion



Status:Completed
Conditions:Other Indications, Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:December 1, 2011
End Date:August 3, 2015

Use our guide to learn which trials are right for you!

Fatigue and Amotivation Following Mild Traumatic Brain Injury and Their Influence on Service Member Community Reintegration

Background:

- 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.

Objectives:

- To learn more about the problems that may occur after service members have a concussion
during deployment and return home.

Eligibility:

- 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.

Design:

- 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.

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.

- INCLUSION CRITERIA mTBI GROUP:

- Diagnosis of at least one mTBI during deployment;

- At least six months from time of injury;

- Age range 18 or older;

- A self-report of somatic or behavioral symptoms that developed within 3 months
following mTBI and were not present before injury, and may or may not be present at
enrollment:

- Easy fatiguability

- Sleep disturbance

- Headache or other chronic widespread pain that does not seem related to extremity
injury

- Emotional lability

- Lack of spontaneity or apathy

- Lack of motivation

- Feelings of anxiety

- Personality change that they or others have noticed

- Irritability or aggressiveness

- The mTBI participant provides informed consent.

EXCLUSION CRITERIA mTBI GROUP:

- Daily use of stimulants, narcotics, hypnotic or anxiolytics

- Diagnosis of sleep apnea, thyroid disorder, or rheumatoid arthritis

- Any history of head injury associated with a loss of consciousness that lasted longer
than 24 hours (not including sedation);

- Daily use of more than 600mg caffeine (equivalent to approximately five cups of
coffee).

- Headaches more than once a month prior to deployment;

- Pregnancy;

- Claustrophia;

- Inability to comfortably lie supine for two hours

INCLUSION CRITERIA companion group

- Chosen by a mTBI participant as a close companion (i.e, spends or in the last 3 years
has spent a minimum of 1 hour per week on average with the mTBI participant and with
whom the mTBI participant is comfortable discussing personal matters);

- The companion provides informed consent.

EXCLUSION CRITERIA companion group:

-Lack of understanding of the English language
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
?
mi
from
Bethesda, MD
Click here to add this to my saved trials