INTRAOPARATIVE NEUROLOGICAL MONITOR (INM)

描述：（申请人摘要中的逐字记录）NINDS征集 的提案认识到，迫切需要一种技术， 在手术过程中和关键时刻不断评估大脑的状态 监护室。我们非常同意这种看法。我们的合作小组有 一直在研究基础科学中的体感诱发电位（SEPs） 过去十年的观点。两年前，我们着手减少结果 将这项工作转化为一个强大的，易于使用的临床设备， 检测神经损伤。我们很高兴地报告，在 在我们的第一阶段合同中，我们超越了既定的具体目标， 原型术中神经监测仪（INM），并在 NIH/NINDS。该设备重量不到四磅， 灵敏的彩色屏幕，具有直观的用户友好图形用户界面 接口.此外，它还集成了新颖的降噪和EP信号 分析算法，并在一系列的实验研究进行了验证。 我们很高兴能够提交第二阶段的申请， 建立临床格拉德所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干扰性。我们 将在一系列受控动物研究中进一步验证该器械， 在一个临床试验中，包括开颅手术和脊髓手术。 该器械不仅将用于手术室，还将用于随访。 神经重症监护室（NCCU）。结果将与 临床神经学检查以及其他常规方法， 评估神经系统状态 拟定商业应用： 我们乐观地认为，我们将成功地实现我们的最终目标： 用于解释诱发电生理的创新信号处理技术 活动在嘈杂的环境中变成一个强大的，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.