The results of a study conducted at Washington University Barnes Jewish Medical Center in St. Louis indicate that the FDA-cleared BrainScope One medical device reduced the use of unnecessary head CT scans by nearly one-third in a hospital emergency room setting when compared to the use of standard clinical practice. Stats show that emergency room (ER) visits for mild Traumatic Brain Injury (mTBI) have greatly increased due to increased awareness of potential consequences of such injuries. While the clear majority (>80%) of head-injured patients who go to the ER receive a head CT scan, more than 90% of them are found to be negative. This practice unnecessarily exposes these patients to radiation, increases the use of hospital ER resources, and lengthens throughput times.
BrainScope’s BrainScope One product is a multi-modal, comprehensive, handheld system that helps clinicians objectively and rapidly assess and triage head injured patients directly at the point of care. BrainScope One is allegedly the first and only FDA-cleared medical device to offer capabilities to assess the full spectrum of brain injury, from concussions (functional abnormality) to brain bleeds (structural injury).
In the study, ninety-one (91) patients presenting to the ER within 3days of sustaining a closed head injury (with a mean time since injury of 10.8 hours) were evaluated at Barnes-Jewish Hospital Washington University Medical Center ER. Patients were 18-76 years of age, and all but one had a Glasgow Coma Scale (GCS) score of 15 (one patient GCS=14). Eighty-two percent (82%) of the injuries were caused either by motor vehicle collisions or falls. All ninety-one patients were referred for a head CT scan, which was read by the site neuroradiologist and evaluated for related traumatic brain injury.
Patients also received a 5-to-10 minute BrainScope EEG-based Structural Injury Classifier (“SIC”) evaluation using a proprietary disposable EEG headset, which is rapidly and easily placed on the forehead region. Physician assistants, nurses and/or technicians administered the BrainScope evaluation, which utilizes proprietary Artificial Intelligence (AI) - based algorithms to provide clinically-relevant information to determine whether a patient is likely CT positive (structural brain injury) or likely CT negative (no structural brain injury).
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