EYE-TRAC Advance A research study funded by the Department of Defense
BROCHURE CONTENTS About BTF..................................................... 1 Eye-Trac Advance Overview....................................1 A Normative Database of Eye-Tracking................................ 2 Studying Concussion in High-Risk Groups.............................3 Study Participation...........................................4 Frequently Asked Questions.............................................5 A Letter From Senator Hannon................................... 6 Principal Investigator Barry E. Kosofsky, MD, PhD Co-Principal Investigator Jamshid Ghajar, MD, PhD For a complete list of investigators and further information about the study, please visit: www.braintrauma.org/eta. The EYE-TRAC Advance study has been reviewed and approved by the Weill Cornell Medical College Institutional Review Board. Brain Trauma Foundation 7 World Trade Center, 34 Fl., Suite B New York, NY 10007 P: 212-772-0608 F: 212-772-0357 www.braintrauma.org ii
ABOUT BTF The Brain Trauma Foundation is a New York based non-profit research organization whose mission is to translate neuroscience into effective solutions for traumatic brain injury patients. BTF research focuses on the diagnosis and treatment of traumatic brain injury, from coma to concussion. BTF has a 25-year history of service and is the only organization in the world that develops best practice guidelines for severe traumatic brain injury. BTF is dedicated to improving the quality of life for individuals who have suffered head injuries. EYE-TRAC ADVANCE OVERVIEW EYE-TRAC Advance (ETA) is a Department of Defense (DoD) funded study which examines the relationship between eye-tracking, attention, and predictive timing. ETA will enroll over 5,000 athletes, 5,000 military participants, and several hundred civilian participants. Eye-tracking and predictive timing can be defined as a person s ability to accurately eye track a moving target. Accurate predictive timing in eye-tracking is a measure of how well someone pays attention, which we all rely on. EYE-TRAC Advance has two primary goals: To establish a normative database of eye-tracking performance with individuals who have no history of a concussion (a form of mild traumatic brain injury) To study abnormal eye-tracking, neurocognitive performance (attention, memory, reaction time, etc.), and brain imaging (MRI) following a concussion Pictured above, BTF staff stand in front of the EYE-TRAC Advance mobile testing center (See page 4) eye-trac advance, page 1
NORMATIVE DATABASE OF EYE-TRACKING Recent research has demonstrated that people who sustain a concussion may have behavioral and cognitive disabilities. Due to the nature of athletic and military activities (i.e., contact sports, combat), athletes and military personnel are among the most at risk for experiencing a concussion. BTF seeks to better understand brain function for visual tracking in these populations. The DoD has partnered with BTF to understand the relationship between normal and abnormal eye-tracking and cognitive performance. BTF has developed customized portable EYE- SYNC goggles and selected sensitive tests to understand the relationship between eye-tracking and various cognitive domains such as processing speed, reaction time, attention, and predictive timing. BTF Program Director Kevin Coppersmith (pictured above) demonstrates a prototype version of the EYE-SYNC goggles Previous research has demonstrated that eye-tracking may be a quick and objective measurement of predictive timing and attentional capacity- two important areas of cognitive performance for participation in demanding athletic and military activity. In the future, portable EYE-SYNC goggles may be used at the sideline of games, or in far forward military operations. Dr. Jamshid Ghajar, President and Founder of the Brain Trauma Foundation and Clinical Professor of Neurological Surgery at Weill Cornell Medical College, examines brain scan data. eye-trac advance, page 2
STUDYING CONCUSSION IN HIGH-RISK GROUPS Athletes are at risk for concussion and following a concussive event may exhibit problems, such as attention deficits and symptoms. In particular, military operations have traditionally involved explosives that can result in blast injuries. We need to measure the deviations from normal eye-tracking and cognitive performance, so that the readiness of an athlete to return to play or for a soldier to return to active duty can be appropriately gauged. Provided below are bulleted statistics discussing the prevalence of concussions in athletes and military personnel. Athletes There are between 1.6 and 3.8 million sports-related concussions every year in the United States. Concussions account for a significant percentage of total injuries among athletes participating in various sports, including collegiate ice hockey (12%), football (8%), and soccer (5%). Youths between ages 10 to 19 account for 71% of emergency hospital visits for sports or recreation-related traumatic brain injuries (e.g. concussions or more severe traumatic brain injury). Military Personnel Between 10 and 20% of Iraq veterans, or 150,000 and 300,000 service members, have some level of traumatic brain injury. 30% of wounded soldiers admitted to Walter Reed Army Medical Center have been diagnosed as having had a traumatic brain injury. Traumatic brain injury is the most common outcome of a blast injury due to land mines, rocket-propelled grenades, and improvised explosive devices. eye-trac advance, page 3
STUDY PARTICIPATION EYE-TRAC Advance is currently recruiting participants for all enrollment groups. Athletes: Ages 12 and up, can participate in the study. Based on eligibility, athletes will have the opportunity to receive: Baseline testing: This evaluation records brain tests, including eye tracking, that are different from currently available commercial computerized tests. Post-injury testing: If a participant sustains a concussion, he/she may undergo a full neurocognitive testing battery, which is currently recommended for concussion management. This includes tests that analyze memory, attention, and reaction time. Post-injury Magnetic Resonance Imaging (MRI): In addition to neurocognitive testing, participants may also receive MRI scans. MRI is a non-invasive imaging technique that examines brain anatomy in greater detail. The raw score results of neurocognitive tests and a copy of the MRI scan may be provided to a participant to share with a healthcare provider. Military Personnel: One of the aims of this study is to create a large eye-tracking database for healthy military personnel with no previous history of concussion in the last five years. Testing is currently being conducted at Fort Hood military base in Texas and USARIEM army research facility in Massachusetts. Civilians: BTF is also currently recruiting non-athletes/non-military personnel to participate in the EYE-TRAC Advance study. BTF is seeking people of all different ages, from 7 to 66+, to study normal and abnormal eye tracking and cognitive testing results. In particular, we are looking for individuals who fit into any of the following categories: Normals: No history of head injury Eyesight disorder: For example: color blindness, macular degeneration, presbyopia, etc. Concussion: Recently sustained an acute mild traumatic brain injury TESTING SITES Study participation will take place at BTF offices in NYC, or in one of our Mobile eye-tracking and brain Testing Centers (MTC). The MTC is an RV equipped with study equipment and staffed by BTF trained research assistants. The MTC can be driven directly to a school, university, or other participating institution. eye-trac advance, page 4
Is there compensation for participation in this study? Athlete and civilian participants are eligible to be compensated for participation. Compensation will be provided at the completion of each testing session with a check card or a gift card to a retailer. BTF can customize the type of compensation for school districts. For example, gift cards to sport retailers, restaurants, or other popular venues can be provided. Athletes Baseline Testing: $15 Follow-up Testing (post-mtbi): Cognitive tests: $130 MRI scan (if eligible): $150 each session Civilians FREQUENTLY ASKED QUESTIONS Cognitive testing & eye tracking (randomly selected): Long: $130 Short: $75 MRI scan (if eligible): $150 each session How will confidentiality be maintained? Data will be de-identified, which means that all elements of any identifiable information will be removed to ensure that participants will not be singularly identified. Data will be identified only via a randomly assigned subject number, which will not be derived from or be related to any information about a participant, nor will it be translated to identify a participant. Only BTF and designated affiliates will have access to de-identified study data. BTF is fully compliant with the Health Insurance Portability and Accountability Act (HIPAA), a privacy rule that provides federal protections for personal health information. These standards and the study have both been reviewed and approved by the Investigational Review Board at Weill Cornell Medical College. Will information gathered from this research study be used to determine return to sport-related activities after an injury? BTF is not a medical provider and accordingly cannot make that determination for a participant following an injury. However, upon request BTF can provide a participant with relevant data to give to a healthcare provider to aid in making decisions regarding safety and readiness to return to play after an injury. To learn more or contact us with questions, please visit www.braintrauma.org/eta or call 212-608-3063. eye-trac advance, page 5
In 2011 New York State passed the Concussion Management Awareness Act, which established guidelines for concussion management in schools. Senator Kemp Hannon, founder of this act, has formally endorsed and partnered with BTF to inform school districts and universities of this opportunity for participation. Administrators or representatives from an institution, such as a regional college, school district, or sports center, can help BTF achieve their recruitment goal. Participation will enhance compliance with the New York State Concussion Management Awareness Act. Furthermore, parents and student athletes may have the chance to benefit from cutting edge concussion research. A LETTER FROM SENATOR HANNON As senator of New York s 6th district, I am committed to taking a stand against Traumatic Brain Injury among youth. In 2011, my administration passed the Concussion Management Awareness Act, a law mandating that schools enforce government regulations for the treatment and monitoring of brain injury. This year, I am taking TBI efforts a step further by endorsing the efforts of the Brain Trauma Foundation to improve TBI diagnosis and treatment. Sponsored by a grant from the Department of Defense, the Brain Trauma Foundation has developed a unique eye-tracking technology that can be used to screen traumatic brain injury within minutes. The results from their IRB sponsored research has the potential to save thousands of lives every year, and would provide parents with the peace of mind to know that their schools are taking every initiative to protect their children against traumatic brain injury. I have given my full support to the Brain Trauma Foundation and I am asking you to stand by me in educating and protecting our children from sport-related concussion. Senator Kemp Hannon Sixth District New York, New York eye-trac advance, page 6