NEW YORK, June 12, 2017 /PRNewswire/ -- The novel eye tracking device EyeBOX™ has been shown to rapidly and accurately detect brain abnormalities resulting from concussions and other head injuries by noninvasively measuring the effects of elevated intracranial pressure (ICP), according to data published in the peer-reviewed Journal of Neurosurgery.
Each year more than seven million Americans are estimated to suffer traumatic brain injuries (TBIs), the most common type being concussion.1 Traumatic brain injury can result in brain swelling, which leads to increased pressure in the skull, or elevated ICP. The current standard of care to accurately measure ICP is to drill a hole in the skull and place a pressure-detecting probe directly into the brain. Given the invasive nature of this procedure, it is only performed in patients with severe brain injury rather than in patients with concussion.
"Diagnosing elevated ICP noninvasively will enable many people with traumatic brain injuries to receive an appropriate diagnosis and treatment," said Uzma Samadani, M.D., Ph.D., associate professor of neurosurgery at the University of Minnesota, inventor of EyeBOX, founder of Oculogica, Inc., and neurotrauma consultant to the National Football League. "EyeBOX was designed to measure ICP by tracking eye movement to quickly, accurately and noninvasively diagnose concussions and other traumatic brain injuries. We are encouraged that the data from the clinical study published in Journal of Neurosurgery show a statistically significant correlation between abnormal eye movements and elevated ICP, since it supports the potential for EyeBOX as an advance in brain injury diagnosis."
Oculogica plans to file for U.S. Food and Drug Administration (FDA) clearance of the device under the rigorous de novo device review process, which requires statistically significant clinical validation of the product. If cleared, EyeBOX would be the first eye tracking device cleared by the FDA to diagnose concussions and other TBIs.
There have been over 3,000 eye-tracking scans conducted with EyeBOX to date. Research with the device is being conducted at many leading institutions, including Boston Children's Hospital, Children's Hospital of Philadelphia, Mayo Clinic, Rocky Mountain Concussion Clinic, Southern Methodist University and University of Minnesota.
About Conditions Associated with Elevated Intracranial Pressure
A concussion is a type of traumatic brain injury that results in temporary disruption of normal brain function. It is typically caused by a blow to the head and may be associated with elevated intracranial pressure (ICP). Consequences of untreated elevated ICP include headache, vision problems progressing to blindness, nausea, vomiting, impaired thinking and death.
Elevated ICP is believed to be the cause of the sudden deaths that occur when sports players return to play in a concussed state and suffer a second blow to the head – a condition termed second impact syndrome.
"I see hundreds of kids with varying degrees of concussions in my practice, and rapid, accurate diagnosis is essential to determining whether a concussed child can return to sports," said Christina L. Master, M.D., pediatric primary care sports medicine specialist at the Children's Hospital of Philadelphia. "Just because a kid gets back up on the field doesn't mean the injury isn't serious." Dr. Master did not participate in the published study, which was conducted in adults, but is currently conducting studies using EyeBOX in a pediatric population.
Noninvasive diagnosis of elevated ICP will also benefit the 7 million people living with hydrocephalus in the United States.
About the Study
The study evaluated how results from EyeBOX, a simple, noninvasive eye-tracking device, correlate to the invasive method of measuring ICP through drilling a hole in the skull.
The study included 23 patients who required ICP monitoring with a probe as part of treatment for brain bleeding, tumors or stroke. The patients watched music videos and film clips while a camera measured their eye movements for 220 seconds. Results were compared with traditional measurement of ICP.
Data showed a statistically significant correlation between increased ICP and decreased function of the nerves moving the eye, as measured by EyeBOX. Decreased lateral eye movements showed the strongest correlation with elevated ICP, consistent with known patterns of eye movement in patients with elevated ICP.
The study was funded by the National Space Biomedical Research Institute (NSBRI), which partners with NASA under the SMARTCAP program to support the commercialization of technologies that have utility both in space and on Earth.
"Astronauts exposed to microgravity experience vision problems similar to people on Earth with elevated ICP," said Dr. Dorit Donoviel, Deputy Chief Scientist and Industry Forum Lead at NSBRI and Assistant Professor in the Department of Pharmacology and Center for Space Medicine at Baylor College of Medicine. "Being able to identify elevated ICP noninvasively is critical for space travel."
The full study, entitled "Elevated Intracranial Pressure and Reversible Eye-Tracking Changes Detected While Viewing A Film Clip," was released online by the Journal of Neurosurgery at http://thejns.org/doi/full/10.3171/2016.12.JNS161265 and will appear in a future print edition.
EyeBOX™ is a novel device that uses a proprietary combination of hardware and software to monitor eye movements while a patient watches a film clip of their choosing for about four minutes. Eye movements are correlated via data analysis to specific neurologic functions to quantify the physiologic impact of ICP.
About Oculogica, Inc.
Oculogica, Inc., was founded by a neurosurgeon, Uzma Samadani, M.D., Ph.D., in 2013 based on her research at the New York Harbor HealthCare System. Dr. Uzma Samadani is now the Rockswold Kaplan Endowed Chair for TBI at Hennepin County Medical Center and an Associate Professor of Neurosurgery at the University of Minnesota. Rosina Samadani, Ph.D., a former consultant with McKinsey & Company, has served as CEO of the company since 2015. The company uses machine learning on large data sets of eye-tracking measurements to develop algorithms for the diagnosis of concussion, elevated ICP, and other brain dysfunction. The company is seeking FDA clearance for its machine learning based algorithms and has several patents issued or pending, including a recently issued patent for assessment of the physiologic impact of elevated ICP. Oculogica is located in New York, NY and New Richmond, WI. To learn more about Oculogica visit www.oculogica.com.
About National Space Biomedical Research Institute
NSBRI, a 501(c) (3) organization partnered with NASA, is studying the health risks related to long-duration spaceflight and developing the technologies and countermeasures needed for human space exploration missions. The Institute's science, technology and career development projects take place at approximately 60 institutions, distributed across the United States. For more information, please visit www.nsbri.org. The Industry Forum engages the private sector to develop medical products for both space and Earth through commercialization activities and seed funding. Find out more at www.NSBRIforum.org and follow the NSBRI Industry Forum on Twitter and Facebook.
1 Arbogast, K.B., Curry, A. E., Pfeiffer, M.R., et al, (2016). Point of Health Care Entry for Youth with Concussion Within a Large Pediatric Care Network. Journal of the American Medical Association Pediatrics, 170, 7.
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SOURCE Oculogica, Inc.