NEW ACOUSTIC DEVICE FOR CLINICAL BRAIN TRAUMA DIAGNOSIS

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DESCRIPTION: (Verbatim from the Applicant's Abstract) Active Signal Technologies proposes to clinically evaluate decisions made with a newly developed non-invasive acoustic measurement technique and compare with physician judgement based on invasive skull0-peetrating pressure measurement catheters at the University of Maryland Shock Trauma Center (STC). This process represents the next logical step before seeking FDA approval in a long-term development effort to exploit real-time analysis of acoustic interaction with the brain and changes in its acoustic properties to assess clinical criticality of head injury. Based on ongoing clinical trails of the device at STC Active Signal has identified several features and parameters in the low frequency power spectrum of the brain which in combination establish whether viability has been compromised in the normal cerebral regulation and compensation mechanisms as manifested in high ICP or low CPP. The algorithm will be assessed on a least 30 patients, first by statistical correlation with individual medical measures of brain state (ICP, CPP, CT exam, etc.), an then once the algorithm is improved and refined, it will be compared with clinician judgement, progress of pathology, and medical outcome. PROPOSED COMMERCIAL APPLICATION: The commercial application for the BAM are two: 1) A laptop based system available to hospital neurotrauma staff for diagnostics and management of brain injured patients. 2) A handheld device available to EMS personnel that will allow an assessment of the severity of brain injury at the site of the injury prior to assignment to an emergency facility. Both of these applications will be further explored in Phase II of the current program.