LOS ANGELES--(BUSINESS WIRE)--Please replace the release with the following corrected version due to multiple revisions.
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NEURAL ANALYTICS ENROLLS FIRST PATIENT IN CLINICAL STUDY TO EVALUATE TRANSCRANIAL DOPPLER ANALYTICAL PLATFORM FOR MONITORING OF MILD TRAUMATIC BRAIN INJURY
Neural Analytics Inc., a medical device company developing and commercializing technology to measure, diagnose and track brain health, today announced the company’s enrolled its first patient in a two-year study to develop a method for evaluating cerebral blood flow in patients with mild traumatic brain injury (TBI) using its Lucid M1 Transcranial Doppler (TCD) Ultrasound System™. The Lucid System is an all-in-one ultrasound system designed for measuring and displaying cerebral blood flow velocities of patients with brain disorders.
Meeryo Choe, MD, co-Principal Investigator of the study, and the research team at the University of California Los Angeles (UCLA) Steve Tisch BrainSPORT Program will divide the study’s 240 subjects from Los Angeles area high schools and colleges into three groups. These groups include individuals who have been affected by mild TBI, “In Sport” controls (high-risk contact sports, i.e. football and hockey) and “Out of Sport” controls (low-risk contact sports, i.e. baseball and tennis).
The study is designed to include both diagnostic and return-to-participation (RTP) components. This will support the development of a new objective method for quantification of well-known physiologic changes after a mild TBI, such as impairment of autonomic function and altered cerebral blood flow (CBF). The study is actively enrolling subjects and conducting assessments at UCLA to compare cerebral hemodynamic impairment measured with Neural Analytics’ Lucid System to clinical evaluations and magnetic resonance imaging (MRI) techniques.
“Understanding the pathophysiology of a concussion is very important to treating patients in a timely fashion,” said Christopher Giza, MD, Director of the UCLA Steve Tish BrainSPORT program and co-Principal Investigator of the study. “The findings of this study can potentially help us identify the subtle changes that aren’t easily detected using current diagnostic methods in treating and managing individuals with mild TBI.”
Current mild TBI diagnostic methods and RTP assessments are based on patient symptoms, neurocognitive evaluations and/or physical tests. They are not suitable for a significant majority of mild TBI patients because patient symptom assessments are subjective and variable, while neurocognitive evaluations and physical tests require a pre-injury baseline not usually available.
“There’s a need for a definitive method for mild TBI assessment, in particular for determining if a patient is ready to return to playing after a sports concussion, especially in high school and college athletes,” said Robert Hamilton, Ph.D., PI of the study, Co-Founder and Chief Scientific Officer of Neural Analytics. “Findings from this study may help inform physicians on return to play decisions.”
The rate of concussions in high school and colleges is reported to be as high as 1.5 and 3 per thousand events respectively in the U.S.1
Globally, each year, severe blood flow disorders affect more than 30 million people. TBI and stroke contribute the most to the global disease burden for these disorders. There are 14.8 million people affected by TBI worldwide annually, with 2.5 million in the United States.2,3
The study is part of a $3 million grant Neural Analytics received from the National Institutes of Neurological Disorders and Stroke of the NIH Award #R44NS092209.
About Lucid M1 Transcranial Doppler Ultrasound System™ (Lucid System)
Neural Analytics’ Lucid M1 Transcranial Doppler Ultrasound System™ (Lucid System), FDA cleared and CE marked, is an all-in-one ultrasound system designed for measuring and displaying cerebral blood flow velocities and monitoring of patients with brain disorders. The Lucid System is a battery operated medical grade tablet device. It uses a type of ultrasound called Transcranial Doppler (TCD) to assess the brain’s blood vessels from outside the body. This analysis can be performed in the physician’s office, and can help the physician diagnose brain disorders, potentially without the need for additional, more invasive tests. Many significant brain disorders are caused by blood flow disruption.
About Neural Analytics Inc.
Neural Analytics was founded in 2013 to create products and services to measure, diagnose and track brain health. They combine leading data science with cutting edge hardware to allow first responders and clinicians to accurately assess and monitor brain health issues. Their devices are designed to be portable, autonomous, reliable, and produce precise and objective physiological measurements for medical responder monitoring of neural disorders. More information is available at http://www.neuralanalytics.com.
Sources:
1. Daneshvar, “NIH Public Access,” Clin Sport. Med., vol. 30, no. 1, pp. 1–17, 2011.
2. http://www.cdc.gov/traumaticbraininjury/severe.html
3. Bryan-Hancock, C. et. Al.The global burden of traumatic brain injury: preliminary results from the Global Burden of Disease Project. Inj Prev 2010;16:A17 doi:10.1136/ip.2010.029215.61