NEW ACOUSTIC DEVICE FOR CLINICAL BRAIN TRAUMA DIAGNOSIS

用于临床脑外伤诊断的新型声学装置

• 批准号: 6394153
• 负责人: JOHN Milton SEWELL
• 金额: $ 45.41万
• 依托单位: ACTIVE SIGNAL TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-06-17 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6394153
• 关键词: biomedical equipment development; brain disorder diagnosis; brain injury; clinical research; computer program /software; diagnosis design /evaluation; head /neck injury; human subject; intracranial pressure; measurement; noninvasive diagnosis; patient monitoring device; sound frequency; trauma

DESCRIPTION: (Verbatim from the Applicant's Abstract) Active Signal Technologies, Inc. (AST) proposes to advance, during Phase II, the development of its non-invasive Brain Assessment Monitor (BAM) that was successfully tested on 30 patients during Phase I. AST's partner, the R. Adams Shock Trauma Center (STC) at the University of Maryland, will conduct an expanded clinical study designed to demonstrate correlations of the BAM indications with traditional measures of intracranial pathology. Specifically, AST will refine the sensor and electronics to be more universal in application, and add signal processing to increase accuracy and automate decision making. Active Signal will test the upgraded system on healthy volunteers until satisfied it produces zero false positive, and then will produce and deliver two units to STC for the clinical study. The STC will evaluate approx. 300 head-injured patients using the BAM upon admission and track approx. 100 receiving invasive monitors throughout their treatment. Correlations will be made between BAM indications and clinical evaluation on admission needs for subsequent interventions and outcome. Upon Phase II's conclusion this new non-invasive technology will achieve a statistically-demonstrated operational accuracy, currently available only with invasive techniques or CAT/MRI scans, thereby significantly increasing accessibility and reducing costs of brain-injury assessment. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE

描述：（逐字摘自申请人摘要）主动信号 Technologies, Inc. (AST) 提议在第二阶段推进开发 其无创大脑评估监测仪（BAM）已成功测试 在第一阶段对 30 名患者进行了研究。AST 的合作伙伴 R. Adams 休克创伤中心 马里兰大学（STC）将进行一项扩大的临床研究 旨在展示 BAM 指标与传统指标的相关性 颅内病理学测量。具体来说，AST将改进传感器 和电子学在应用上更加通用，并增加信号处理 提高决策的准确性和自动化。活动信号将测试 对健康志愿者进行升级系统，直到满意为止，产生零错误 呈阳性，然后将生产并交付两个单位给STC用于临床 学习。 STC 将评估大约。 300 名头部受伤患者使用 BAM 入场后并跟踪约。 100个接收侵入式监视器 他们的治疗。将在 BAM 适应症和临床之间建立关联 评估后续干预措施和结果的入院需求。之上 第二阶段的结论 这种新的非侵入性技术将实现 统计证明的操作准确性，目前仅适用于 侵入性技术或 CAT/MRI 扫描，从而显着增加 脑损伤评估的可及性并降低成本。 拟议的商业应用：不可用