NEW ACOUSTIC DEVICE FOR CLINICAL BRAIN TRAUMA DIAGNOSIS

描述：(逐字摘自申请者摘要)激活信号 技术公司建议临床评估使用新的 发展的非侵入性声学测量技术及其与 基于有创颅内压测量的医生判断 马里兰大学休克创伤中心(STC)的导管。这一过程 代表了在长期寻求FDA批准之前的下一个合乎逻辑的步骤 开发工作，以利用声学相互作用的实时分析 大脑及其声学特性的变化以评估临床危害性 头部受伤。根据STC Active正在进行的该设备的临床试验 信号在低频下识别了几个特征和参数 大脑的功率谱结合起来确定是否有生存能力 在正常的大脑调节和补偿中受到了损害 其机制表现为高颅内压或低CPP。将对算法进行评估 在至少30名患者上，首先通过统计与个人相关 脑状态的医学测量(颅内压、CPP、CT检查等)，然后每一次 对算法进行了改进和改进，将其与临床医生的判断进行了比较， 病理学的进展和医学结果。 拟议的商业应用：BAM的商业应用 有两个：1)基于笔记本电脑的系统，可供医院神经创伤工作人员使用 颅脑损伤患者的诊断和处理。2)提供手持设备 给急救人员，这将使评估脑损伤的严重性在 在被分配到急救设施之前，受伤的地点。这两个都是 应用程序将在当前计划的第二阶段进一步探索。

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.