Brain Injury Research at NIH

1. Brain Injury Research at NIH Alison Cernich, Ph.D., ABPP-Cn Director National Center for Medical Rehabilitation Research Eunice Kennedy Shriver National Institute of Child Health and Human Development

2. Overview • NIH Overview • Traumatic Brain Injury Research at NIH • Rehabilitation Research Plan & Resources • How Can you Be A Part? • Moving Forward

3. National Institutes of Health • Mission: Seek fundamental knowledge about the nature & behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability • Organizationally constituted by the Office of the Director and 27 Institutes and Centers

4. National Center for Medical Rehabilitation Research (NCMRR) Established in 1990 within NICHD to promote rehabilitation research within the NIH, coordinate efforts of the ICs, and promote collaboration with other federal agencies Lead for Trans NIH Medical Rehabilitation Coordinating Committee Rehabilitation Research Plan Federal Interagency Coordination

5. TBI Research Support: NIH • In 2015, NIH funded $93 million dollars in TBI research from 16 Institutes, Centers, and Offices (www.projectreporter.nih.gov) • Depending on the type of research an investigator pursues, the type of support needed, and the topic area, different Institutes and Centers would support it

6. NINDS Common Data Elements • Standardize data • Facilitate sharing • Increase comparability of studies • Includes • TBI • Concussion • Pediatric Concussion

7. Federal Interagency Traumatic Brain Injury Research • Over 200,000 patient clinical records from over 4500 patients • Over fifteen funded researchers have contributed as of July 1, 2015.

8. Why Build Big Data for TBI? • Data that are comparable and can be combined are powerful • NICHD released a funding opportunity to promote opportunity to use data for secondary analyses • Funded 9 studies at a lower cost than an individual project • Broad range of topics https://projectreporter.nih.gov/reporter_SearchResults.cfm?icde=33469397

9. BRAIN Initiative • Develop and apply cutting edge technologies to create a dynamic picture of the brain in action • Interagency initiative with lots of other agencies involved (National Science Foundation, Department of Defense) • Includes public-private partnerships to advance science

10. BRAIN Initiative • Brain Scanning Helmet • Deep Brain Stimulation for Moderate to Severe Brain Injury • Drugs to turn neurons on and off • Large scale recording and modulation of brain activity • Noninvasive neuromodulation techniques http://www.hsc.wvu.edu/news/story?headline=portable-pet-helmet-captures-images-ofhuman-brain-in-motion

11. BRAIN Initiative • New trial starting in humans will use deep brain stimulation to treat cognitive limitations following TBI • Looking at clinical feasibility of central thalamic stimulations for people with severe to moderate TBI • Similar to approaches used in Parkinson’s disease, obsessive-compulsive disorder, and depression https://projectreporter.nih.gov/project_info_description.cfm?aid=9148199&icde=33469465&ddparam=&ddvalue=&ddsub=&cr=40&csb=default&cs=ASC&pball=

12. TRACK-TBI • Following over 2,000 individuals with brain injury • Including neuroimaging, blood biospecimens, and clinical data • Includes older adults and children • Finding genetic ties to some outcomes (genes related to cognitive outcomes) • Refining biomarkers for TBI 1U01NS086090-01

13. ADAPT Trial • International study with multiple sites • Enrolling 1,000 children with severe TBI who require intracranial pressure monitoring • Comparative effectiveness • Strategies to control intracranial hypertension • Mitigation of bleeding and loss of oxygen to the brain • Strategies to provide metabolic support 5U01NS081041-02

14. NETT • Treatment trial network focused on the acute phase of care • 22 participating primary hospitals that have three spoke hospitals associated with it • Trials • BOOST-3 – starting soon, explores if brain tissue oxygen monitoring improves neurologic outcomes in severe TBI • HOBIT – starting soon, determine treatment parameters for use of hyperbaric oxygen treatment in severe TBI • ProTECT – completed and provided no evidence that progesterone was effective to treat acute TBI 5U01NS056975-10

15. Biomarkers • Looking for markers in blood, saliva, urine, or spinal fluid that might predict outcome or diagnose injury • Biomarkers are especially important for mild injury • Recent study funded by NINR and NICHD found blood protein tau could be important to predict recovery https://www.nih.gov/news-events/news-releases/biomarker-blood-may-help-predict-recovery-time-sports-concussions

16. Rehabilitation • Predicting long term outcome at time of diagnosis or discharge from rehabilitation • Effective strategies for • Cognitive rehabilitation • Walking and gait problems • Speech-language therapies for communication problems • Functional rehabilitation for activities of daily living • New drug therapies • Ways to address depression and anxiety following TBI

17. Neurodegeneration • Brain injury can increase risk of changes in the brain over time – greater than what is normally expected • Chronic traumatic encephalopathy (CTE) is a diagnosis for brain changes related to repetitive injury to the brain that causes symptoms similar to other dementias • NIH is examining how to diagnosis, track, protect, prevent, and treat CTE

18. NIH Research Plan on Rehabilitation Rehabilitation Across the Lifespan Community and Family Technology Use and Development Research Design and Methodology Translational Science Building Research Capacity and Infrastructure https://www.nichd.nih.gov/publications/pubs/Documents/NIH_ResearchPlan_Rehabilitation.pdf

19. Research Infrastructure www.ncmrr.org

20. Meetings • Rehabilitation Research Conference • BRAIN Initiative Investigators Meeting • Pediatric Sports Concussion • Clinical Trials in Rehabilitation • Devices for Pediatric Rehabilitation • Upcoming: Medical Devices for Rehabilitation

21. How can I participate? • Find a clinical trial • Provide input to a request for public input • Propose a study • Mentor a researcher • Talk to people about why research helps people with TBI https://clinicaltrials.gov/

22. Active Funding Opportunities • Research to Address Sleep Disorders in the Context of Medical Rehabilitation (R01) • http://grants.nih.gov/grants/guide/pa-files/PAR-17-163.html • NICHD Research Education Programs (R25) • http://grants.nih.gov/grants/guide/pa-files/PAR-17-183.html • NCMRR Early Career Research Award (R03) • http://grants.nih.gov/grants/guide/pa-files/PAR-17-161.html • Brain Initiative FOAs • https://www.braininitiative.nih.gov/funding/ • Promoting Caregiver Health Using Self-Management • https://grants.nih.gov/grants/guide/rfa-files/RFA-NR-16-003.html

23. Resources • NCMRR webpage: https://www.nichd.nih.gov/about/org/ncmrr/ • Join the Rehabilitation Research Listserv: https://www.list.nih.gov; rehab-nih • NIH Homepage: www.nih.gov • NIH Reporter: Database of all NIH-funded grants searchable by topic or institution/locale http://projectreporter.nih.gov/repoter.cfm • Center for Scientific Review: Study section descriptions and rosters www.csr.nih.gov • Videos on NIH Peer Review: http://cms.csr.nih.gov/ResourcesforApplicants/InsidetheNIHGrantReviewProcessVideo.htm

24. Questions