Surgical Monitor for Detection of Spinal Cord Injury

用于检测脊髓损伤的手术监视器

• 批准号: 6585089
• 负责人: Ananth Natarajan
• 金额: $ 17.5万
• 依托单位: INFINITE BIOMEDICAL TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-04-01 至 2004-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6585089
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; electrophysiology; evoked potentials; laboratory rat; nerve decompression; orthopedics; patient monitoring device; somesthetic sensory cortex; spinal cord injury; spinal cord surgery; surgery material /equipment

DESCRIPTION (provided by applicant): Somatosensory evoked potential (SSEP) monitoring during spinal surgery has been associated with a 60% reduction in paraplegia. However, subjective interpretation of signals is not always accurate, and a significant learning curve has been demonstrated. Therefore, we propose the development and testing of innovative quantitative signal processing algorithms, focused on the detection of injury. In our Phase I effort, we will use adaptive Fourier analysis of SSEPs to evaluate parametric changes in the signal, and correlate the results with injury. We will further develop a spectral coherence analysis approach that results in an index of injury we call the Linearity Index. The injury detection algorithm will then be validated using an established rat model of graded spinal cord injury. Electrophysiological measurements will be performed by an expert neuroelectrophysiologist. We will then critically examine the problems of false-positives and false-negatives during SSEP monitoring, as well as study timely detection of spinal cord injury at various spinal compression ratios. If we are successful, we envision a Phase II focused on clinical validation of the device, improved noise-immunity, and investigation of human-subject specific alarm threshold criteria. It is our long-term goal to see the device used as a rapid, accurate sentry for detection of spinal cord compromise during high-risk surgeries.

描述（由申请人提供）：脊柱手术期间的体感诱发电位 (SSEP) 监测与截瘫减少 60% 相关。然而，信号的主观解释并不总是准确的，并且已经证明了显着的学习曲线。因此，我们建议开发和测试创新的定量信号处理算法，重点关注损伤检测。在我们的第一阶段工作中，我们将使用 SSEP 的自适应傅里叶分析来评估信号的参数变化，并将结果与​​损伤相关联。我们将进一步开发一种光谱相干分析方法，产生我们称为线性指数的损伤指数。然后将使用已建立的分级脊髓损伤大鼠模型来验证损伤检测算法。电生理学测量将由神经电生理学家专家进行。然后，我们将批判性地研究 SSEP 监测过程中的假阳性和假阴性问题，并研究在不同脊柱压缩比下及时检测脊髓损伤。如果我们成功了，我们预计第二阶段的重点是设备的临床验证、改进的抗噪性以及人体特定警报阈值标准的调查。我们的长期目标是将该设备用作快速、准确的哨兵，在高风险手术期间检测脊髓损伤。