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Research > ActiveProtocols

Active Protocols

The NICoE research team currently has 14 active Institutional Review Board (IRB) approved protocols focused on advancing the evaluation and categorization of service members with the complex interaction of traumatic brain injury (TBI) and psychological health (PH) conditions. These protocols are conducted in collaboration with other scientists and researchers in federal government, academia and private industry.

Upon acceptance into the NICoE program, service members may be offered the opportunity to participate in on-going IRB approved research. Participation in research is voluntary and is not a requirement for acceptance into the NICoE program. Eligibility for participation in research protocols and willingness to participate in research studies has no bearing on the decision to offer participation in the NICoE clinical evaluation and treatment planning program, and has no impact on completeness or quality of care received. The service member may decline any or all of the research components of the evaluation. 

Study Name and Description
Institutional Affiliations
Principal Investigator (PI)
Advanced Imaging Acquisition and Data Analysis for a Military Traumatic Brain Injury (TBI) Neuroimaging Database
This study seeks to compile a database of over 500 neuroimaging images of eligible TBI patients. These studies are collected and analyzed in order to determine the most effective imaging methods for characterizing and tracking the TBI disease state. The highly individualized nature of TBI necessitates a large number of subjects to discover distinct sub-categories of TBI symptomatologies. The study combines multiple modalities of magnetic resonance imaging (MRI) and positron emission tomography (PET) and hypothesizes that TBI diagnosis will result from careful characterization of individual modalities followed by advanced multi-modal analysis.
Uniformed Services University of the Health Sciences (USUHS)
Walter Reed National Military Medical Center (WRNMMC)
Center for Neuroscience and Regenerative Medicine (CNRM)
Fort Belvoir
NICoE POC: Dr. Gerard Riedy
Dual-Task Assessment using the Computer Assisted Rehabilitation Environment (CAREN): Implications for Service Members with Co-morbid mTBI and PTSD
The goal of this study is to compare outcome measures obtained from a conventional dual-task assessment to a CAREN dual-task assessment to determine whether the CAREN can provide additional insight into dual-task performance.
Internal to the NICoE
NICoE POC: Ms. Sarah Kruger
Assessing the Impact of mild Traumatic Brain Injury (mTBI) on Multisensory Integration while Maneuvering on Foot
This study evaluates auditory-visual-vestibular integration by measuring the localization error and reaction time required to identify a target with and without visual/audio cues in both static and walking conditions.
WRNMMC
PI: Dr. Douglas Brungart
NICoE POC: Ms. Sarah Kruger
Exploring the Natural History of Traumatic Brain Injury (TBI) within a Military Cohort - A Longitudinal Database
The study seeks to improve understanding of TBI by developing a database that contains important TBI-related information. The study is sponsored by the Defense and Veterans Brain Injury Center (DVBIC), with funding provided by the Department of Defense (DoD). The goal of the study is to generate information that policy makers can use to improve the care of service members with TBI. The data collected for the study will provide the foundation for the development of hypothesis-driven protocols.
WRNMMC
Fort Belvoir
Defense and Veterans Brain Injury Center (DVBIC)
PI: Dr. Louis French  
NICoE POC: Dr. Gerard Riedy
Enhancing Exposure Therapy for Post-Traumatic Stress Disorder (PTSD): Virtual Reality (VR) & Imaginal Exposure with a Cognitive Enhancer
This study seeks to identify the superior method for treating PTSD and determine the efficacy of D-Cycloserine (DCS) for augmenting both Virtual Reality Exposure (VRE) as well as Prolonged Exposure (PE). Service members are randomized to receive either VRE or PE, in conjunction with random selection to a cognitive enhancer called DCS or a placebo/inactive agent. The four groups will then be compared: VRE plus DCS, VRE plus placebo, PE plus DCS, and PE plus placebo.
 USUHS
Emory University
Weill Cornell Medical College in New York City
Veterans Health Administration  (VHA)Hospital in Los Angeles
Institute for Creative Technologies at University of Southern California
PI: Dr. Michael Roy
NICoE POC: Ms. Denece Clayborne
The Community Balance and Mobility Scale: Assessment of Service Members with mTBI and PTSD
This study seeks to establish a collection of results for the Community Balance and Mobility scale test and compare data for the Activities-specific Confidence Scale, Functional Gait Assessment and gait speed in active duty service members with and without a history of mTBI and PTSD.
Internal to the NICoE
NICoE POC: Ms. Marcy Pape
Brain Injury and Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms after mTBI
The goal of this study is to describe the brain function and anatomy of service members with Post Concussive Syndrome (PCS). The study uses a comprehensive battery of assessments, across time to receive intervention (hyperbaric oxygen) or sham control, and explore potential associations between changes in function, anatomy, and participant reported outcomes.
The role of the NICoE in this study is to supervise and perform analysis for neuroimaging data and to integrate these results with other clinical measures.
 
University of Utah
Fort Evans Army Community Hospital
Fort Carson, CO

Las Vegas Imaging Center

Martinos Center Massachusetts General Hospital/Harvard
PI: Dr. Lindell Weaver
NICoE POC: Dr. Gerard Riedy
Differential Assessment of mTBI and PTSD Using Functional Brain Imaging Techniques (MEG/EEG)
This study seeks to characterize mTBI with the utility of the MEG. Various tasks are employed to assess different areas of cognition amongst service members with a diagnosis of mTBI, PTSD and controls.
Walter Reed Army Institute of Research (WRAIR)
NICoE POC: Dr. Thomas DeGraba
Integration of Image and Clinical Measurements of TBI Patients Using Machine Learning Techniques
 
The study performs a methodical and in-depth assessment of how data mining techniques can be used to integrate multimodal clinical data coming from different TBI evaluations. In order to effectively characterize the biological state of patients with mTBI/PTSD, a large collection of multi-modal clinical variables must be considered, evaluated, and modeled simultaneously using advanced analytical and data mining techniques.
Internal to the NICoE
NICoE POC: Dr. Jesus Caban
The National Intrepid Center of Excellence (NICoE) Clinical Research Database to Study the Natural History of Traumatic Brain Injury and Psychological Health Outcomes in Military Personnel
This study focuses on improving the understanding of TBI, PTSD and other PH conditions. Comprehensive data is collected and maintained from service members enrolled at the NICoE, to analyze injuries, symptoms and efficacy of treatment being utilized at the NICoE.
 
Internal to the NICoE
 
NICoE POC: Dr. Thomas DeGraba
The ViRTICo-BP Trial: Virtual Reality Therapy and Imaging in Combat Veterans with Blast Injury and Posttraumatic Stress Disorder
This study seeks to demonstrate that Virtual Reality Exposure Therapy (VRET) is feasible for the treatment of combat-related PTSD and establish an initial estimate of the efficacy of VRET in combat veterans. In order to demonstrate the fMRI can distinguish between four groups of Operation Iraqi Freedom or Operation Enduring Freedom veterans: blast exposure and PTSD; blast exposure and no PTSD; no blast exposure, with PTSD; and no blast exposure or PTSD.
 
USUHS
 
PI: Dr. Michael Roy  
NICoE POC: Ms. Donna Neuges
National Capital Consortium Evaluation of MRI Hardware and Software in Control Subjects
The study develops and evaluates software and hardware used with MRI at 3.0 Tesla to assess brain tissue structure and function in order to develop neuroimaging techniques for the MRI scanner, as opposed to examining a specific disease state. This project uses healthy control subjects for methodology development that can later be applied to TBI patients.
 
Internal to the NICoE
NICoE POC: Dr. Gerard Riedy
NICoE TBI MEG Core Project
This study develops imaging modalities to best translate MEG findings through functional MRI.
National Institutes of Health (NIH)
NICoE POC: Dr. Gerard Riedy
Brain Indices of Risk for PTSD after Mild TBI
The primary aim of this longitudinal study is to improve the ability to predict PTSD in service members who have sustained mTBI or bodily injuries with no TBI. A battery of measures of brain structure (MRI/DTI/SWI) and function (ERPs, neurocognitive, neurological) are evaluated at baseline to identify markers of risk for PTSD over a 6-month period. Secondary aims include investigating associations between brain indices and other outcome measures (post-concussion symptoms, headache, quality of life); evaluating differences between mTBI and injured, non-TBI subjects in terms of outcome; and characterizing differences in indices of brain structure and function between blast and impact mTBI.
WRNMMC
Fort Belvoir
PI: Dr. Connie Duncan
NICoE POC: Dr. Gerard Riedy

Studies Currently Recruiting

Enhancing Exposure Therapy for PTSD: Virtual Reality and Imaginal Exposure with a Cognitive Enhancer

Do you have symptoms of PTSD? PTSD symptoms include:
  • Problems sleeping
  • Difficulty concentrating
  • Irritability
  • Unwanted memories
If so, you may be eligible to participate in a treatment study for combat-related PTSD for OIF/OEF veterans being conducted at the National Intrepid Center of Excellence on the campus of Walter Reed National Military Medical Center in Bethesda. We are currently recruiting for a study in which we provide free evidence-based therapy to military veterans, service members, guards, and reservists experiencing symptoms of combat-related PTSD after Iraq or Afghanistan deployment. No formal PTSD diagnosis needed. Must be eligible for Tricare, medically healthy, willing to take study drug, and able to provide informed consent.

For more information or to participate, please contact (240) 507-6339.

This study has been approved by Walter Reed DRP's Institutional Review Board. IRB Protocol # 361712.
 
 

If you have additional questions about the research directorate at the NICoE please click here to contact someone from our research staff.