SBIR-STTR Award

TBI (traumatic brain injury) is the leading cause of long-term disability and death for individuals under the age of 45. Over 2.5 million cases of TBI are reported each year in the United States, with ~3-5 million individuals living with TBI-related disabilities. About 75% of patients diagnosed with TBI are classified as mTBI, which can be difficult to diagnose, as history is often incomplete and symptoms are nonspecific and overlap with a broad range of neuropsychiatric disorders. Although most patients with mTBI make a full recovery, as many as 20% do not. Individuals who experience multiple mTBI are at increased risk of persistent post-injury symptoms and long-term complications, including serious sequelae such as chronic traumatic encephalopathy (CTE). Simple interventions such as removing the patient from risky environments may prevent these complications by allowing time for the brain to heal and preventing further injury. Management of mTBI in the field, in the emergency department, and even in the primary care office is complicated by the absence of a safe, simple, and sensitive tool to assist in making the diagnosis and in tracking a patient's recovery. Rebion has produced a portable device - with compelling preliminary, pilot data - for identifying and monitoring traumatic brain injury in patients by way of a retinal scan. The device, which has FDA clearance (DEN 130051) for identifying misaligned eyes in children, has shown to accurately identify acute episodes of mild traumatic brain injury (mTBI) and track a patient's recovery that matches the medical diagnosis. The device is called HITT, the Head and Intraocular Trauma Test device. Grant support is being requested to support further development of the HITT device so that it can be field deployable in a larger-scale clinical study. The data that has been collected to date has led to a better understanding of the algorithm and electronics requirements that will be needed to make the HITT device usable -and interpretable- by a lay user. Successful execution of project milestones will lead to pivotal clinical studies that will be vetted by the FDA. Data from the studies will be submitted to the FDA for consideration of market clearance of the HITT device.

Public Health Relevance Statement:
Project Narrative Rebion has produced a portable device for providing a quick, noninvasive retina-scan to identify and track brain dysfunction following concussive head injuries that are often referred to as traumatic brain injury (TBI). Based upon findings from pilot studies with a prototype device, Rebion is aiming to use this SBIR to further devlop its device and later test whether it can not only identify TBI but also monitor a patient's response to treatment. The device's approach, unlike eye-tracking or any other available technology, is to assess the quality of signals between the retina and the brain.

Project Terms:
Affect; Age; ages; Algorithms; Birefringence; Birefraction; Double Refraction; Brain; Brain Nervous System; Encephalon; Brain Concussion; Cerebral Concussion; Commotio Cerebri; concussion; Child; 0-11 years old; Child Youth; Children (0-21); children; childrens'; youngster; Clinical Protocols; Clinical Research; Clinical Study; Ocular Convergence; Cessation of life; Death; Decision Making; Diagnosis; Electronics; electronic device; Engineering; Environment; Epidemic; Eye; Eyeball; Goals; Grant; Hand; Head; Craniocerebral Trauma; Craniocerebral Injuries; Head Injuries; Head Trauma; Recording of previous events; History; Hospitalization; Hospital Admission; Lasers; Laser Electromagnetic; Laser Radiation; Light; Photoradiation; Methods; Optics; optical; Legal patent; Patents; Patients; Pilot Projects; pilot study; Primary Health Care; Primary Care; Primary Healthcare; Research; Retina; Risk; Signal Transduction; Cell Communication and Signaling; Cell Signaling; Intracellular Communication and Signaling; Signal Transduction Systems; Signaling; biological signal transduction; Technology; Testing; Time; United States; Binocular Vision; Volition; Measures; injuries; Injury; base; improved; Peripheral; Acute; Clinical; Medical; Neurological; Neurologic; Ensure; disability; pediatric; Childhood; insight; Individual; Recovery; Bilateral; NT mimic 1; mimic 1; neurotensin mimic 1; tool; Scanning; gaze; Emergency Department; Emergency room; Accident and Emergency department; innovative technologies; experience; Performance; success; eye tracking; visual tracking; laptop; Speed; Structure; Participant; novel technologies; new technology; Devices; Reporting; Modeling; performance tests; response; portability; Brain Trauma; traumatic brain damage; Traumatic Brain Injury; Intervention Strategies; interventional strategy; Intervention; Provider; preventing; prevent; Symptoms; Data; Detection; Clinical Evaluation; Clinical Testing; clinical test; research clinical testing; SBIR; Small Business Innovation Research; Small Business Innovation Research Grant; Monitor; Fixation; sample fixation; developmental; Development; point of care; Output; NINDS; National Institute of Neurological Diseases and Stroke; National Institute of Neurological Disorders and Stroke; healing; fight against; designing; design; Outcome; Trauma; Impairment; Graphical interface; graphic user interface; software user interface; graphical user interface; usability; prototype; response to treatment; therapeutic response; treatment response; IRB; IRBs; Institutional Review Boards; ED visit; ER visit; Emergency care visit; Emergency hospital visit; Emergency room visit; Emergency department visit; Traumatic encephalopathy; chronic traumatic encephalopathy; MTBI; mild TBI; mild brain trauma; mild traumatic brain injury; Traumatic injury; neuropsychiatric disease; neuropsychiatric disorder; dysfunctional brain; brain dysfunction; chronic symptom; persistent symptom; patient specific response; responsive patient; patient response

Rebion has produced a portable device - with support from NS117553 - that shows potential for serving as a tool that can identify functional impairment as a result of TBI. The device uses a retinal scan to measure disruptions between the retina and the visual pathway of the brain. The long-term vision of this work is to develop a tool that can serve as a functional assessment of injury at the time of injury, as well as during recovery, and to be paired with currently-available blood-based biomarkers to provide a comprehensive report for patients and providers. The device's approach, unlike eye-tracking or any other available eye technology, is to assess the quality of signals between the retina and the brain. Accurate monitoring of function and overall recovery from TBI are underserved problems in the healthcare system that Rebion is seeking to help solve. TBI (traumatic brain injury) is the leading cause of long-term disability and death for individuals under the age of 45. Over 2.5 million cases of TBI are reported each year in the United States, with ~3-5 million individuals living with TBI-related disabilities. About 75% of patients diagnosed with TBI are classified as mTBI, which can be difficult to diagnose, as history is often incomplete and symptoms are nonspecific and overlap with a broad range of neuropsychiatric disorders. Although most patients with mTBI make a full recovery, as many as 20% do not. These are the patients that Rebion is ultimately focused on helping. Individuals who experience multiple mTBI are at increased risk of persistent post-injury symptoms and long-term complications, including serious sequelae such as chronic traumatic encephalopathy (CTE). Simple interventions such as removing the patient from risky environments may prevent these complications by allowing time for the brain to heal and preventing further injury. Grant support is being requested to support a human-subject study which will compare the Rebion device to a battery of clinical tests - blood biomarkers and neurocognitive assessments - in participants suspected of TBI. Pilot data collected to-date shows promise that this rapid, non-invasive method can serve a useful purpose in the patient's journey through TBI.

Public Health Relevance Statement:
Project Narrative The development of a portable tool that can help with the identification and tracking of traumatic brain injury (TBI) can serve as an important ingredient in a patient's journey through recovery. Successful completion of the proposed study will provide meaningful data that clinicians can pair with already-available methods. Identifying and tracking TBI with the Rebion device can serve as a useful compliment to blood biomarkers, which the device will be compared to in this proposed work.

Project Terms:
Achievement; Achievement Attainment; Affect; Age; ages; Blood; Blood Reticuloendothelial System; Brain; Brain Nervous System; Encephalon; Statistical Data Interpretation; Statistical Data Analyses; Statistical Data Analysis; statistical analysis; Cessation of life; Death; Diagnosis; Dropout; Environment; Eye; Eyeball; Foundations; Grant; Head; Healthcare Systems; Health Care Systems; Blood Tests; Hematologic Tests; Hematological Tests; Hematology Testing; Recording of previous events; History; Learning; Methods; Paper; Patients; Retina; Risk; Running; Saccadic Eye Movements; Saccadic Pursuit; Saccades; Cell Communication and Signaling; Cell Signaling; Intracellular Communication and Signaling; Signal Transduction Systems; Signaling; biological signal transduction; Signal Transduction; Technology; Testing; Time; United States; Vision; Sight; visual function; Visual Pathways; Volition; Wisconsin; Work; Measures; Caring; Injury; injuries; base; human subject; Procedures; Acute; Clinical; Phase; disability; Stimulus; Individual; Recovery; Funding; Acquired brain injury; brain damage; brain-injured; Brain Injuries; tool; programs; Msec; millisecond; Scanning; Neurocognitive; Visit; gaze; experience; Performance; success; eye tracking; visual tracking; polarized light; Speed; Participant; Study Subject; Devices; Reporting; sorting; Sorting - Cell Movement; brain pathway; response; Functional impairment; functional disability; neurocognitive test; portability; Brain Trauma; traumatic brain damage; Traumatic Brain Injury; Intervention Strategies; interventional strategy; Intervention; Provider; preventing; prevent; Symptoms; Data; research clinical testing; Clinical Evaluation; Clinical Testing; clinical test; Enrollment; enroll; Monitor; Process; Modification; sample fixation; Fixation; Development; developmental; Output; healing; design; designing; Outcome; Trauma; Biological Markers; bio-markers; biologic marker; biomarker; phase 2 study; phase II study; chronic traumatic encephalopathy; Traumatic encephalopathy; Traumatic Brain Injury recovery; TBI recovery; recovery after TBI; recovery after traumatic brain injury; mild traumatic brain injury; MTBI; mild TBI; mild brain trauma; neuropsychiatric disorder; neuropsychiatric disease; blood-based biomarker; blood-based marker; recruit; preservation; clinical examination; clinical exam