Status:
COMPLETED
Service Member Fatigue and Lack of Motivation Following Concussion
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Fatigue
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Brief Summary
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 ma...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 3 2015
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01496586
Start Date
December 1 2011
End Date
August 3 2015
Last Update
December 17 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892