National Research Action Plan for Improving Access to Mental ...

National Research Action Plan for Improving Access to Mental ...

Federal Coordination for Traumatic Brain Injury Research: The National Research Action Plan An Interagency Approach to Chronic Problems Stuart W. Hoffman, Ph.D. VETERANS HEALTH ADMINISTRATION Scientific Program Manager for Brain Injury Office of Research and Development US Department of Veterans Affairs [email protected] Disclosure The views expressed are in this presentation do not represent the views of the U.S. Government, Department of Defense, HHS, ED, or any other agency either public or private. I have no relevant financial relationships. VETERANS HEALTH ADMINISTRATION 2 Objectives

1.How do Federal Agencies cooperate on a common initiative? 2.The goals of this initiative 3.Examples of the National Research Plan in Action VETERANS HEALTH ADMINISTRATION 3 Historical Background for the Initiative en.wikipedia.org/wiki/The_Sphere The Sphere is a large metallic sculpture by German sculptor Fritz Koenig, currently displayed in Battery Park, that once stood in the area between the World Trade Center towers in Manhattan. After being recovered from the rubble of the Twin Towers after the 9/11attacks, its fate was initially uncertain and it was dismantled into its components. Although it remained structurally intact, it had been visibly damaged by debris from the airliners that were crashed into the buildings and the collapsing skyscrapers themselves. VETERANS HEALTH ADMINISTRATION 4

Background Since September 11, 2001, more than 2.5 million service members have deployed to Iraq and Afghanistan in Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn. Military forces sent to fight those wars have exhibited a number of unique features, including: 1. an all-volunteer military that has experienced multiple deployments to the war zone, 2. substantial use of the reserve components of the military and National Guard, 3. deployment of high numbers of women and parents of young children, 4. a high number of military personnel surviving severe injuries that in previous wars would have resulted in death. VETERANS HEALTH ADMINISTRATION Wounded to Dead Ratio From the American Revolution to GWOT

IOM (Institute of Medicine), 2014 5 The Legacy Improvements in outer tactical vests (body armor) and helmets have limited fatal injuries, many service members return with a TBI, PTSD, suicidal thoughts or behaviors, and/or related comorbidities. These comorbidities or co-occurring conditions are defined as mental health disorders by the NRAP. Returning Veterans who were seen in VA health care facilities revealed: that nearly one-third of Veterans received at least one mental health or psychosocial diagnosis. Another study estimated that only 23% to 40% of returning service members who screen positive for a mental disorder seek mental health care. Family members are also impacted by the multiple stressors associated with deployment and reintegration. These conditions are anticipated to increase in coming years as the Nation endures the effects of more than a decade of military conflict.

VETERANS HEALTH ADMINISTRATION 6 Signature Wound: The Unknown Prognosis IOM (Institute of Medicine), 2014 VETERANS HEALTH ADMINISTRATION 7 Hack, D. (Digital Image), 2014 VETERANS HEALTH ADMINISTRATION 8 Previous Focus: Acute Mechanisms & Therapies Acute Chronic

Excitotoxic damage Oxidative stress Injury [Protein Biomarker] blood Post-Acute doacto Em txicage Oxdiativestress Inflammation Axonal injury Apoptosis Neuroregeneration Neurodegeneration?

Demyelination Microgliosis Min Hr Years Consciousness Days Cognitive/Behavioral/Sensory Deficits VETERANS HEALTH ADMINISTRATION Weeks Months Reintegration Dementia? Table courtesy of Dr. Hoffman

9 Executive Order 13625 Sec. 5: PTSD, TBI, Suicide Prevention The lack of full understanding of the underlying mechanisms of Post Traumatic Stress Disorder (PTSD), other mental health conditions, and Traumatic Brain Injury (TBI) has hampered progress in prevention, diagnosis, and treatment. In order to improve the coordination of agency research into these conditions and reduce the number of affected men and women through better prevention, diagnosis, and treatment, the Departments of Defense, Veterans Affairs, Health and Human Services, and Education, in coordination with the Office of Science and Technology Policy, shall establish a National Research Action Plan within 8 months of the date of this order. VETERANS HEALTH ADMINISTRATION 10 Executive Order 13625 Sec. 5: Goals Department of Defense, Department of Veterans Affairs, Department of Health and Human Services, Department of Education, 2012 VETERANS HEALTH ADMINISTRATION

11 Authors and Active Participants Psychological Health TBI COL (ret.) Carl Castro, USARMY CAPT Carroll Forcino, USN Dr. Theresa Gleason, VA/ORD Dr. Farris Tuma, HHS/NIMH LTC Dennis McGurk, USARMY Dr. Katherine Nassauer, USARMY Dr. Thomas Insel, HHS/NIMH Dr. Susan Borja, HHS/NIMH Dr. Eve Reider, HHS/NID COL Dallas Hack, USARMY Dr. Kenneth Curley, USARMY COL Wanda Salzer, USARMY Dr. Walter Koroshetz, HHS/NINDS Dr. Ramona Hicks, HHS/NINDS

Dr. Cate Miller, ED/NIDRR Dr. Stuart Hoffman, VA/ORD Dr. Shirley Groer, VA/ORD Dr. Robert OBrien, VA/ORD Dr. Arlene Greenspan, HHS/CDC VETERANS HEALTH ADMINISTRATION Leadership Dr. Michael Stebbins, OSTP Dr. Philip Rubin, OSTP Dr. Timothy OLeary, VA/ORD Dr. Terry Rauch, DoD Dr. Kelley Brix, DoD Dr. Robert Jaeger, VA/ORD Ruth Brannon, ED/NIDRR google.com/imgres?imgurl=http:// www.elitconsultancy.com/assets/img/ ass1.png&imgrefurl=http:// www.elitconsultancy.com/ &h=500&w=870&tbnid=RDQ9lF3NUX90EM &zoom=1&tbnh=170&tbnw=296&usg=__0p EP6xgLxVVmJ6hHT_u1kdLn9KA=

12 craighospital.org/repository/image/Research/NDSCLogo.jpg whitehouse.gov/sites/default/files/uploads/ nrap_for_eo_on_mental_health_august_2013.pdf lcweb.loc.gov/loc/brain/images/doblogo2.gif VETERANS HEALTH ADMINISTRATION 13 VETERANS HEALTH ADMINISTRATION Table courtesy of Dr. Hoffman 14 Current Treatment Research in: Post-Acute Therapies Acute

Post-Acute Chronic Excitotoxic damage Oxidative stress Injury dotacEo m xtciage Oxdiativestress [Protein Biomarker] blood Inflammation Axonal injury Apoptosis Neuroregeneration

Neurodegeneration? Demyelination Microgliosis Min Hr Consciousness Days Cognitive/Behavioral/Sensory Deficits VETERANS HEALTH ADMINISTRATION Weeks Reintegration Months Years Dementia? Table courtesy of Dr. Hoffman

15 Injury/Recovery Trajectories IOM (Institute of Medicine), 2014 Examples of possible long-term consequences after exposure to blast. Panel Asome service members who are exposed to blast will develop acute injuries and will fully recover within a short period of time, fully recover over a long period of time, or develop chronic diseases and disabilities. Panel Bsome service members who are exposed to blast will not experience acute clinically apparent injuries, but may later develop diseases or disabilities, either in the mid- or long term. Panel Csome service members who are exposed to blast will develop acute injuries and then will go on to develop chronic diseases or disabilities even though they had apparently recovered or at least partially recovered in the short term. VETERANS HEALTH ADMINISTRATION 16 VETERANS HEALTH ADMINISTRATION Table courtesy of Dr. Hoffman 17 VETERANS HEALTH ADMINISTRATION

Table courtesy of Dr. Hoffman 18 VETERANS HEALTH ADMINISTRATION Table courtesy of Dr. Hoffman 19 Portfolio Review and Analysis Across Agencies Department of Defense, et al (Digital Image), 2013 VETERANS HEALTH ADMINISTRATION 20 Bottom Line

TBI is a continuum of extremely heterogeneic insults to the sub cellular and cellular structure and function of the brain; effects can be life-long Co-morbidities (PTS, Pain, Depression) are more the rule than the exception Currently, physical/mental rest and education are the only validated treatments and there are no FDA approved therapies Regulatory science is inadequatea reflection of the state of the science in general. Need for validated endpoints for both diagnosis and treatment Because of our limited understanding of the pathobiology, along with a paucity of biomarkers, correlating the human condition with animal models is subjective The relationships between TBI, neurodegeneration and Chronic Traumatic Encephalopathy are yet to be clearly defined Does recovered mean recovered or does it mean compensated? Despite all of the above, we DO find ourselves at a tipping point where coordinated foundational efforts will establish the basis for future studies and real, evidence-based progress in the diagnosis and treatment of TBI VETERANS HEALTH ADMINISTRATION 21

A dedicated joint DoD/VA effort addressing the long term consequences of TBI in Service Members and Veterans. Aligned to Presidential Executive Order 13625 and the National Research Action Plan $62.175M of VA and DoD Funding up to $5M/year for 5 years VA; $37.175M DoD FY12, awarded September 2013 Oversight via Government Steering Committee with representation from DoD, VA, NIH, NIDRR Currently Supporting 6 Studies across 18 Participating Institutions* VCU (Coordinating Center, Dr. David Cifu) Uniformed Services University of the Health Sciences Seattle RTI International Richmond VA Medical Center Tampa VA Medical Center Houston VA Medical Center South Texas Health Care System San Salt Lake City Francisco San Francisco VA Medical Center & NICRE Milwaukee VA Medical Center

Mountain Home VA Medical Center Phoenix San Antonio Military Medical Center Baylor Medical Center Duke University Coordinating Center & Research Site Roskamp Institute Research Site Barrows Neurological Institute Research Sites & Core Brigham Young University Research Core University of Washington VETERANS HEALTH ADMINISTRATION Milwaukee Bethesda Richmond Durham/ Research Triangle Park

Mountain Home San Antonio Tampa Houston * as of September 2014 https://cenc.rti.org Highlights Core facilities for common research efforts Alignment with DVBIC 15 Year Study for TBI Leverages Multiple DoD and VA clinical sites previously funded in-theater efforts for follow up data DoD and VA Centers of Excellence Nationwide expertise of established research networks

Use of common data elements (CDEs) and entry of data into FITBIR Robust Peer Review Program to identify new projects * Comorbidities include: psychological, neurological (memory, seizure, autonomic dysfunction, sleep disorders), sensory deficits (visual, auditory, vestibular), movement disorders, pain (including headache), cognitive, and neuroendocrine deficits FOR OFFICIAL USE ONLY (PROCUREMENT SENSITIVE) Approved CENC Projects & Research Cores Approved Studies* Integrated Research Cores Longitudinal Cohort Study Biostatistics, Data Management and Study Management

ADAPT Biorespository & Biomarkers Core Otolith Dysfunction and Postural Stability Neuroimaging Core Epidemiology of mTBI and Neurosensory Outcomes Neuropathology Core Tau Conformation DTI Standardization * Quad Charts can be found at the end of the slide deck FOR OFFICIAL USE ONLY (PROCUREMENT SENSITIVE) 24 FOR OFFICIAL USE ONLY (PROCUREMENT SENSITIVE)

CENC Project Alignment to DoD/VA National Research Action Plan Priorities NRAP Objective CENC projects or actions Classify/Stage mTBI, including imaging and biomarkers Longitudinal Cohort Study, DTI Standardization Acute/Chronic Effects of mTBI and risk factors Longitudinal Cohort Study, Epidemiology /Outcomes Study, Otolith Dysfunction and Postural Stability Study, TBD New Projects* Causal effects b/n mTBI, longitudinal effects and degenerative changes, including imaging, biomarkers Longitudinal Cohort Study, Epidemiology /Outcomes Study, ADAPT, DTI Standardization, TBD New Projects*

Efficacy of pharmacologic and nonpharmacologic interventions TBD New Projects* Efficacy of Team Interventions for MTBI TBD New Projects* Family and community effects of mTBI Longitudinal Cohort Study, Epidemiology/Outcomes Study, and TBD New Projects* Long-term health needs after mTBI Longitudinal Cohort Study, Epidemiology/Outcomes Study, ADAPT and TBD New Projects* Promote collaboration and data sharing TBD New Projects* & FITBIR submissions * New projects solicited via the CENC Peer Review Program

FOR OFFICIAL USE ONLY (PROCUREMENT SENSITIVE) 25 FOR OFFICIAL USE ONLY (PROCUREMENT SENSITIVE) Study Alignment to Consortium Objectives Longitudinal Cohort Study ADAPT Study Association Causative Effect Otolith Dysfunction & Postural Stability Study

Epidemiology of mTBI and Neurosensory Outcomes Study Tau Conformation Study DTI Standardization Effort Areas to address via new studies FOR OFFICIAL USE ONLY (PROCUREMENT SENSITIVE)

Identify Diagnostic and Prognostic Indicators Develop / advance treatment and rehabilitation methods

neurodegeneration 26 VETERANS HEALTH ADMINISTRATION Table courtesy of Dr. Hoffman 27 End Take Home Message: NRAP has White House visibility Please take the to time download and read the NRAP Cite NRAP in your justifications where appropriate

Think Long-Term! Contact Information: [email protected] 202.443.5762 Department of Veterans Affairs (Photograph). (n.d.). Retrieved August 25, 2014 from polytrauma.va.gov/ VETERANS HEALTH ADMINISTRATION 28

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