Service Member Fatigue and Lack of Motivation Following Concussion
|First Received Date ICMJE||December 17, 2011|
|Last Updated Date||November 11, 2014|
|Start Date ICMJE||December 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01496586 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||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 ] [ Designated as safety issue: No ]|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Service Member Fatigue and Lack of Motivation Following Concussion|
|Official Title ICMJE||Fatigue and Amotivation Following Mild Traumatic Brain Injury and Their Influence on Service Member Community Reintegration|
- 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.
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 ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Cross-Sectional|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||160|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
EXCLUSION CRITERIA mTBI GROUP:
INCLUSION CRITERIA companion group
EXCLUSION CRITERIA companion group:
-Lack of understanding of the English language
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01496586|
|Other Study ID Numbers ICMJE||120030, 12-N-0030|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP