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Full text of "DTIC ADA542454: Deployment-Related Mild Traumatic Brain Injury (mTBI): Incidence Natural History and Predictors of Recovery in Soldiers Returning from OIF/OEF"

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Award Number: W81XWH-08-2-0105 

TITLE: Deployment- Related Mild Traumatic Brain Injury (mTBI): Incidence Natural 
History and Predictors of Recovery in Soldiers Returning from OIF/OEF 

PRINCIPAL INVESTIGATOR: Karen Schwab, PhD 

CONTRACTING ORGANIZATION: 

Henry M. Jackson Foundation for the Advancement of Military Medicine 
Rockville, MD 20852 


REPORT DATE: May 2010 


TYPE OF REPORT: Annual Report 


PREPARED FOR: 

U.S. Army Medical Research and Materiel Command 
Fort Detrick, Maryland 21702-5012 


DISTRIBUTION STATEMENT: 

XX Approved for public release; distribution unlimited 


The views, opinions and/or findings contained in this report are those of the author(s) and 
should not be construed as an official Department of the Army position, policy or decision 
unless so designated by other documentation. 



REPORT DOCUMENTATION PAGE 


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1. REPORT DATE (DD-MM-YYYY) 

01-05-2010 


4. TITLE AND SUBTITLE 


2. REPORT TYPE 

Annual 


Deployment- Related Mild Traumatic Brain Injury (mTBI): Incidence Natural History 
and Predictors of Recovery in Soldiers Returning from OIF/OEF 


3. DATES COVERED (From - To) 

1 MAY 2009-30 APR 2010 


5a. CONTRACT NUMBER 


5b. GRANT NUMBER 

W81XWH-08-2-0105 


5c. PROGRAM ELEMENT NUMBER 


6. AUTHOR(S) 

Karen Schwab, PhD 


5d. PROJECT NUMBER 


5e. TASK NUMBER 


5f. WORK UNIT NUMBER 


7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) 

AND ADDRESS(ES) 

Henry M. Jackson Foundation for the Advancement of Military Medicine 
Rockville, MD 20852 


8. PERFORMING ORGANIZATION REPORT 
NUMBER 


9. SPONSORING / MONITORING AGENCY NAME(S) AND ADDRESS(ES) 
U.S. Army Medical Research and Materiel Command 
Fort Detrick, Maryland 21702-5012 


12. DISTRIBUTION / AVAILABILITY STATEMENT 

Approved for Public Release; Distribution Unlimited 


13. SUPPLEMENTARY NOTES 


10. SPONSOR/MONITOR’S ACRONYM(S) 


11. SPONSOR/MONITOR’S REPORT 
NUMBER(S) 



15. subject terms no suDject terms provide 



16. SECURITY CLASSIFICATION OF: 


a. REPORT 

u 


b. ABSTRACT 

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c. THIS PAGE 

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17. LIMITATION 

18. NUMBER 

OF ABSTRACT 

OF PAGES 

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5 


USAMRMC 


19b. TELEPHONE NUMBER (include area 
code) 


Standard Form 298 (Rev. 8-98) 

Prescribed by ANSI Std. Z39.18 


































Table of Contents 


Introduction 3 

Body 

Key Research Accomplishments 3 
Reportable Outcomes 3 

Conclusion 

References 

Appendices 4 

Supporting Data 4 


Page 


3 


4 

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Introduction 


The overarching aim of this study is to describe the epidemiology, natural history, and 
prognostic predictors of mild traumatic brain injury (mTBI) in a well- defined cohort of 
recently- deployed soldiers at Fort Carson and Fort Bragg. This study will augment the 
ongoing surveillance and clinical efforts at these locations by expanding the post¬ 
deployment assessment of traumatic brain injury (TBI) and TBI- related exposures; 
identifying pre-existing and deployment- related exposures and comorbid conditions 
that may influence the risk or prognosis of mTBI-related sequelae; and re- assessing 
this cohort at three, six, and twelve months after return from deployment with the aim of 
determining the persistence of post-deployment symptoms and the degree to which 
these symptoms impact on military or civilian employment, including fitness for military 
duty, functional status, and quality of life. 

Body 

Award W81XWH-08-2-0105 was issued to the Henry M. Jackson Foundation for the 
Advancement of Military Medicine (HJF), effective 1 May 2008. The protocol review 
process was completed for Fort Carson, and is in its final stages for Fort Bragg. The 
Fort Carson site successfully recruited 189 subjects beginning 24 August 2009, and 
recruited a second wave of 189 subjects in May/June 2010. The Qualitative Sub-study 
has recruited a total of 103 subjects over the two recruitment cycles. The protocol for 
the Fort Bragg study site was approved by the WAMC IRB and CIRO on 22 April 2009. 
HJF signed a CRADA with CIRO on 12 May 2009 for the WAMC protocol. Final 
approval to start the study at Fort Bragg was placed on hold due to reassignment of the 
PI to another Army MTF. The new PI has reviewed the protocol and is finalizing it for 
resubmission to the WAMC IRB. The protocol for the Fort Carson study site was 
approved by the BAMC IRB on 1 April 2009 contingent upon minor clarifications. These 
clarifications have been made and the protocol has been resubmitted to the BAMC IRB 
for review by CIRO. 


Key Accomplishments 

• All Quarterly Reports submitted on schedule, per (award) terms and conditions. 

• Protocol for the Fort Bragg study site approved by local IRB and CIRO on 22 April 
2009. Protocol on hold until new PI identified. Protocol has been revised to 
accommodate modifications made at Fort Carson and PI is finalizing it for 
resubmission. 

• Protocol for the Fort Carson study site approved by local IRB on 1 April 2009. Local 
IRB transferred to MAMC, approval obtained after IRB, HJF, and CIRO reviews. 
Protocol deviations reported and reviewed, and study received approval to continue 
recruitment in time for second recruitment wave. 

• 169 subjects from the first wave of subject recruitment continue to be followed by 
phone for the study (20 have been lost to follow-up or declined further follow-ups); 
188 of the 189 subjects from the second wave of subject recruitment will be 
contacted for the first follow-ups shortly (1 subject has withdrawn from consent). 


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Reportable Outcomes 

No research findings are available at this time. 


Conclusion 

The following is a summary of key administrative/management actions during the 
reporting period: 

• Award W81XWH-08-2-0105 issued to HJF, effective 1 May 2008. 

• Staff required for the study at Fort Bragg have been hired and trained. Additional 
staff will be recruited before the first recruitment of subjects begin. 

• Staff required for the study at Fort Carson have been hired and trained. 

References 

N/A at this time 

Appendices 

N/A at this time 

Supporting Data 

N/A at this time 


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