Grant will support clinical trial in collaboration with leading institutions, including Carilion Clinic and the Virginia Tech Carilion School of Medicine
BRAINBox Solutions, Inc. today announced that the company, in collaboration with leading institutions, including Carilion Clinic and the Virginia Tech Carilion (VTC) School of Medicine, has been notified that they have been awarded a $3.5 million SBIR grant from the National Institute of Neurological Disorders and Stroke (NINDS) to support the clinical development of a multi-modal system for the diagnosis and prognosis of occult mild traumatic brain injury (mTBI or concussion) and cognitive impairment in elderly patients.
The test, BRAINBox Geriatrics, builds on the company’s BRAINBox TBI adult test that is currently undergoing a pivotal clinical trial (HeadSMART II). It is designed to integrate blood biomarkers with functional tests to enable rapid mTBI diagnosis and prognosis at the bedside with a single device. There are currently no approved blood biomarker tests for diagnosis, nor combined with functional testing and no approved prognostic tests.
“mTBI in geriatric adults is a major and growing public health concern, yet this population remains the most underrepresented population in TBI research,” stated Ramon Diaz-Arrastia, MD PhD FAAN, Presidential Professor, Director of Traumatic Brain Injury Clinical Research Center at the University of Pennsylvania. “As a result, there are no objective tools to accurately diagnose or predict outcomes in geriatric TBI patients.” Dr. Diaz-Arrastia serves on the BRAINBox Scientific Advisory Board (SAB).
Since 2013, US adults over the age of 75 have had the highest incidence of TBI and rates of geriatric TBIs and subsequent mortality have doubled in the past decade1,2,3. Emergency department visits, hospitalizations, and deaths continue to rise disproportionately to their younger peers, who have garnered more public and research attention4,5. Geriatric patients have the highest TBI mortality and poorest neurological and functional outcomes compared to any other age group, even when normalized for injury severity6,7.
Damon Kuehl, MD FACEP, Vice Chair of Emergency Medicine for Carilion Clinic and Associate Professor of the VTC School of Medicine’s Department of Emergency Medicine, commented, “Elderly patients requiring acute care visits after evidence or suspected head trauma commonly receive computed tomography (CT). Despite most geriatric patients receiving this test, CT is very limited as a diagnostic or predictive tool in the geriatric TBI patient. TBI-related abnormalities are present on CT in only 10 percent of patients evaluated in emergency departments, yet a significant number of patients have disabling TBI symptoms despite initially negative imaging.” Furthermore, he noted that TBIs and dementia, which also predominantly affect the elderly, have a well-documented and dangerous interplay. Dr. Kuehl is an investigator on the grant and a member of the BRAINBox SAB.
The grant will support the test’s development and clinical trial, The HeadSMART Geriatrics Study. The system will integrate the BRAINBox system components developed, building upon data from the HeadSMART (Head injury Serum markers and Multi-modalities for Assessing Response to Trauma) Study (completed in 2017), and the HeadSMART II Study launched as an expansion of the original study, intending to validate the combined device as a system and obtain FDA clearance.
Through the grant, the BRAINBox TBI test will be modified as necessary to refine the system for optimum performance in this underserved and difficult to diagnose population. The resulting system will then be equilibrated to the geriatric population, designed to enable rapid mTBI diagnosis and prognosis at the bedside with a single device. Rachel Gardner, MD Associate Professor at the Memory and Aging Center at the University of California San Francisco, acted as an advisor to the design and development of the Geriatrics Clinical Study.
Donna Edmonds, BRAINBox CEO, stated, “We are grateful for this additional funding, which provides us the opportunity to expand our technology, clinical and scientific evidence to this important population. With this grant, we are one step closer to our goal of developing TBI tests for all patient groups. In addition to the HeadSMART Geriatrics and HeadSMART II trial of the BRAINBox TBI System in adults, we plan to launch the HeadSMART Pediatrics clinical study in the first half of 2022.”
The BRAINBox TBI Test is a novel point-of-care (POC) system that applies a multi-modal approach to the diagnosis and prognosis of TBI. The system uses a multiplex biomarker fluorescent immunoassay, together with tablet-based neurocognitive testing to algorithmically diagnose and provide a prognosis in mTBIs.
About BRAINBox Solutions
BRAINBox Solutions is developing the first AI‐enabled, multi‐modality approach for the diagnosis and prognosis of Mild Traumatic Brain Injury, commonly referred to as a concussion. The company seeks to establish a clinical best‐practice standard for the diagnosis and prognosis of concussion. The product incorporates a panel of proprietary, patented blood biomarkers that can be read in a few moments on a point‐of‐care instrument or using standard laboratory systems, as well as neurocognitive testing, to provide a single‐system score. The score provides a positive or negative diagnosis and the likelihood of symptoms from the injury so that clinicians can determine the appropriate treatment. The company is led by key physician and scientific thought leaders in the field and an experienced, clinically focused management team.
1 TBI Data and Statistics | Concussion | Traumatic Brain Injury | CDC Injury Center. Published April 10, 2019. Accessed March 17, 2020. https://www.cdc.gov/traumaticbraininjury/data/index.html
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3 McIntyre A, Mehta S, Aubut J, Dijkers M, Teasell RW. Mortality among older adults after a traumatic brain injury: A meta-analysis. Brain Inj. 2013;27(1):31-40. doi:10.3109/02699052.2012.700086
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5 Peters ME, Gardner RC. Traumatic brain injury in older adults: do we need a different approach? Concussion Lond Engl. 2018;3(3):CNC56. doi:10.2217/cnc-2018-0001
6 TBI in Older Adults: A Growing Epidemic. Psychiatric Times. Accessed June 30, 2021. https://www.psychiatrictimes.com/view/tbi-older-adults-growing-epidemic
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8Bouzat P, Ageron F-X, Thomas M, et al. Modeling the Influence of Age on Neurological Outcome and Quality of Life One Year after Traumatic Brain Injury: A Prospective Multi-Center Cohort Study. J Neurotrauma. 2019;36(17):2506-2512. doi:10.1089/neu.2019.6432