Stephanie A. Kolakowsky-Hayner, PhD, CBIST, FACRM is the Chief Operating Officer at the Brain Trauma Foundation (BTF). She is also BTF’s Principal Investigator on the Brain Trauma Evidence-based Consortium (B-TEC) project funded by the U.S. Army Research, Development and Engineering Command (RDECOM).
Thank you Dr. Kolakowsy-Hayner for participating. Before we dive into technology, can you tell our readers about the Brain Trauma Foundation and its history?
For 30 years, Brain Trauma Foundation (BTF) has been conducting innovative clinical research and developing evidence-based guidelines that improve outcomes for the millions of people who suffer from traumatic brain injuries every year. From concussion to coma, BTF’s expertise allows us to better educate athletes, coaches, families, and medical professionals for improved prevention, diagnosis, and treatment.
In 1986, Dr. Jamshid Ghajar and the board of the Sunny von Bulow Coma and Head Trauma Research Foundation founded BTF in order to support ongoing research on TBI. In the late 1980s, BTF began awarding TBI research fellowships to young neurosurgeons at top universities to advance their research and foster interest in head injury.
Incorporating evidence found in our ongoing clinical research, we collaborate with medical experts and organizations around the world to develop, update, and refine best practice guidelines for TBI. Results show that the implementation of TBI guidelines produces improved efficiency and outcomes for professionals and patients, beginning with the pre-hospital management phase and extending throughout long-term application of care.
BTF’s first evidence-based Guidelines for Managing Severe TBI was developed in 1995. This pivotal patient care standard was the result of collaboration between a national and international group of experts dedicated to finding the best evidence to improve patient outcomes. In the two decades since, BTF has developed additional guidelines including Management of Pediatric Severe TBI, Early Prognosis in Severe TBI, Surgical Management of TBI, Pre-hospital Management of Severe TBI, and Field Management of Combat-Related TBI. Additionally, in 2014, BTF published our Concussion Guidelines Step 1, which established an evidence-based definition of prevalent and consistent indicators of concussion.
BTF’s evidence-based guidelines are considered the best practice of care for TBI patients and are used in trauma centers all over the world. Our guidelines for the treatment of adults with severe traumatic brain injury are soon to be published in their 4th edition. Updates are in progress for our pediatric, pre-hospital, and concussion guidelines as well.
In addition to the development of evidence-based guidelines, BTF continues to focus on conducting innovative clinical research and working towards its goal of improving outcomes for the millions of people who suffer from traumatic brain injuries every year.
What are some of the current highlights of the BTF’s research program?
Brain Trauma Foundation constantly seeks to improve the diagnosis and treatment of TBI. To do this, we lead the way in cutting-edge clinical research spanning the spectrum from concussion to coma. We are primarily funded by the Department of Defense and partner with some of the most prestigious research organizations, such as Stanford University, Oregon Health & Sciences University, Portland State University, Oregon State University, Weill Cornell Medical College, University of Southern California, University of Utah, and University of California Santa Barbara.
Our current research includes Eye-Tracking Rapid Attention Computation Advance (ETA), Eye-Tracking Rapid Attention Computation Advance Technology Verification (ETA-TV), and the Brain Trauma Evidence-based Consortium (BTEC).
ETA administers and immediately scores eye-tracking tests in a field setting. Since 2012, the U.S. Department of Defense funded, EYE-TRAC Advance study examines the utility of eye-tracking as a marker of attention impairment in individuals with concussion. Data is collected using a predictive circular visual tracking paradigm (called EYE-SYNC), characterized by a red target moving in a circular pattern. Four arms of the study include:
Military Study (1) – Visual-tracking Performance Normative Database
Location: Fort Hood Military Base
Subjects: 5,500 military personnel
Military Study (2) – Visual-tracking Performance with MRI-DTI
Location: USARIEM (Natick Army Base)
Subjects: 150 military personnel
Civilian Study – Visual-tracking Performance Normative Database
Location: New York State, Boston, and Palo Alto
Subjects: 5,360 civilians
Longitudinal Study of Concussion Subjects
Baseline and post-injury data will be collected from high school and college athletes
Location: New York State, Boston, and Palo Alto
Subjects: Civilian concussions- 300
ETA-TV, is a sub-study of ETA including a multi-center trial to verify the use of eye tracking technology on the sidelines of competitive sports and practices, including contact and non-contact sports. The study provides the ability to assess not only a concussed individual, but a normal control participating in the exact same sport at the exact same time. Cohort 1 is measuring the effect of exercise and non-concussive hits on EYE-SYNC Scores. Study measures are being collected pre/post and at contact and non-contact practices for 150 athletes at Stanford University. Cohort 2 is testing the utility of EYE-SYNC as a monitor of recovery from injury over time. The study is evaluating concussions in contact sports, with paired controls, tested at the sideline acutely, then at 1, 7, and 14 days post injury in 100 athletes at Oregon State University, University of California Santa Barbara, University of Southern California, and the University of Utah.
The Brain Trauma Evidence-Based Consortium (BTEC) is a Brain Trauma Foundation and Stanford University partnership with Oregon Health and Sciences University and Portland State University that aims to develop an evidence-based classification for the spectrum of traumatic brain injury, and to model post-TBI trajectories and outcomes. BTEC was developed to solidify existing collaborations and forge new partnerships among brain trauma investigators in a unified effort to ground brain injury research in evidence-based principles and produce objective scientific advances in classification, diagnosis, and treatment of traumatic brain injury.
It is our hope that BTEC will inspire a commitment to the principles of evidence-based medicine in the design and conduct of brain trauma research. To help in this effort, BTEC has established an Evidence-based Clinical Research Coordinating and Training Center at Stanford University, integrating best-practice fundamentals of clinical research with those of evidence-based medicine, which will have the capability to coordinate the next generation of studies required to answer key questions about brain trauma epidemiology, physiology, natural history, treatment, and outcomes.
What current initiatives are the BTF involved with that utilize technology in assessment and treatment of TBI?
A 2008 Department of Defense TBI Advanced Technology award funded BTF’s development of a portable device that detects concussion in seconds. Today, that technology is fully functioning and being applied and tested through BTF’s EYE-TRAC Advance Study. In 2009, BTF helped spin off Sync Think, Inc., a technology company dedicated to developing a commercial goggle eye tracking solution for concussion. Recently, EYE-SYNC was cleared by the FDA for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment.
What are some of the specific challenges to developing and researching technological tools and interventions in TBI?
One of the biggest challenges in developing and researching technological tools and interventions in TBI is the proper classification of individuals entering into the study. Mild, moderate, severe is no longer an appropriate or specific enough classification system for properly enrolling participants. Additional subclassifications, that are more sensitive to the heterogeneity of brain injury, need to be established. We believe this is one of the largest hindrances to failed clinical trials in TBI. Without clearly and objectively establishing severity, investigators cannot be sure they are enrolling the correct patients, ultimately impacting the study outcome or failure to detect change based on intervention.
Are there any promising technology applications in TBI you see coming in the near future that have piqued your interest?
Yes, there are very many exciting and promising technologies being developed in the brain injury space. Given the increased awareness due to the military conflicts over the past 15 years, as well as the concussion crisis secondary to all of the media hype surrounding football, there are a lot of researchers trying to develop objective measures and treatments for individuals with brain injury.
Some emerging technologies include various ocular vestibular assessment tools for identifying concussion. For example, in addition to SyncThink’s EYE-SYNC goggles that we are researching and using clinically, Neuro Kinetics, Inc. is researching the FDA cleared I-Portal NOTC (neuro-otologic test center) and a portable version I-Portal PAS (portable assessment system with a head-mounted display and eye tracking). Georgia Tech Research Institute, Georgia Tech, and Emory University School of Medicine are investigating iDETECT, an integrated platform for multimodal assessment and management of mild traumatic brain injury including neurological symptoms, neurocognitive testing, balance testing, and ocular vestibular integrity. Neural Analytics is investigating a combined transcranial Doppler ultrasound, machine learning, and robotics approach to assess cerebral blood flow changes after mile TBI.
BrainCare, is a 45-60 minute computerized cognitive battery that helps characterize deficits in need of retraining after a neurological insult and suggests personalized cognitive retraining activities a patient can implement at home. The Neural Pathfinder Project, an interdisciplinary collaboration between clinicians and researchers at the San Francisco Martinez VA Medical Centers, is developing training tools to enhance goal-directed neurocognitive functioning after brain injury. Litesprite is developing games to treat anxiety and depression that can be implemented on a tablet or smart phone and interface with an electronic medical record, proving the capability to share information with clinicians and family as well as the patient.
There are also a number of studies being conducted on accelerometers, helmets, and other detection and prevention technology too.
ABOUT THE INTERVIEWER
Tina M. Trudel, PhD, CBIST is the Chief Executive Officer and Clinical Neuropsychologist for Northeast Evaluation Specialists, providing assessment and rehabilitation at locations throughout New England. She is a NABIS Board member, author of over 50 brain injury publications, and co-editor of the recent Essential Brain Injury Guide 5.0.