INTRAOPERATIVE NEUROLOGICAL MONITOR (INM)

描述：(逐字摘自申请者摘要)NINDS征集 For Proposal认识到迫切需要一种技术来迅速和 持续评估手术中和危重中的大脑状态 护理室。我们强烈同意这种观点。我们的协作小组已经 我从基础科学的角度研究体感诱发电位 过去十年的观点。两年前，我们开始减少结果 将这项工作转化为一种强大、易于使用的临床设备，用于快速、准确 神经损伤的检测。我们很高兴地报告，在联合国 我们的第一阶段合同，我们超过了我们规定的具体目标，并建立了一个工作 原型术中神经监护仪(INM)并在 NIH/NINDS。这款设备重量不到4磅，具有触控功能 具有直观、用户友好的图形用户界面的灵敏彩色屏幕 界面。此外，它还结合了新的降噪和EP信号 分析了算法，并在一系列实验研究中得到了验证。 我们很高兴能提交这份第二阶段的申请，意在 建设临床级信息管理中心。我们的具体目标特别关注 性能和结果分析以及易用性和抗噪性。我们 将在一系列受控动物研究中进一步验证该设备 在一项涉及开颅手术和脊髓手术的临床试验中。 该装置不仅将用于手术室，还将用于后续的手术室 神经危重监护室(NCCU)。结果将与 临床神经学检查及其他常规检查方法 评估神经状况。 建议的商业应用： 我们乐观地认为，我们将成功实现我们的最终目标：将 用于诱发电信号解释的创新信号处理技术 将嘈杂环境中的活动转化为功能强大、易于使用的临床设备 快速、准确地检测神经损伤。

DESCRIPTION: (Verbatim from the Applicant's Abstract) The NINDS solicitation for proposals recognizes the great need for a technology to rapidly and continuously assess the state of the brain during surgery and in the critical care unit. We strongly agree with this sentiment. Our collaborative group has been studying somatosensory evoked potentials (SEPs) from a basic science viewpoint for the past decade. Two years ago, we set out to reduce the results of this work into a robust, easy to use clinical device for rapid, accurate detection of neurological injury. We are pleased to report that with the aid of our Phase I contract, we exceeded our stated Specific Aims and built a working prototype Intraoperative Neurological Monitor (INM) and demonstrated it at the NIH/NINDS. The device weights less than four pounds and features a touch sensitive color screen with an intuitive user-friendly graphical user interface. Additionally, it incorporates novel noise reduction and EP signal analysis algorithms and was validated in a series of experimental studies. We are very excited to submit this Phase II application with the intent of building the clinical grad INM. Our specific aims pay special attention to performance and outcome analyses as well as ease of use and noise immunity. We will further validate the device in a series of controlled animal studies as well during a clinical trial involving craniotomies and spinal cord surgeries. The device will not only be used in the OR, but also in follow-up in the Neurocritical Care Unit (NCCU). The results will be correlated with the clinical neurological exam as well as with other conventional methods of assessing neurological status. PROPOSED COMMERCIAL APPLICATION: We are optimistic that we will succeed in our ultimate goal: to incorporate innovative signal processing techniques for interpretation of evoked electrical activity in noisy environments into a robust, easy to use clinical device for rapid accurate detection of neurological injury.