Improving ALS Diagnosis using Needle I-EMG

项目总结 针状肌电图(EMG)仍然是评估神经肌肉疾病的标准方法。而当 在过去的80年里，这项技术被证明是有临床价值的，但它有重要的局限性。这些 包括它对肌肉成分和结构的变化不敏感，它无法评估 肌肉收缩装置及其主观性质，评分者之间的可靠性仅为60%， 对疾病的特异性仅为70%。一种可以无缝集成到肌电针中的技术 为了克服它的局限性，电阻抗肌图(EIM)。通过将EIM和EMG合并为一个 针头装置最终有可能极大地提高肌电的准确性，这是临床标准 产生了一种“更智能的肌电”技术来评估神经肌肉疾病。这一新技术的发展 “更智能的肌电”技术被称为针阻抗肌电图仪(i-emg)，它是 总部设在马萨诸塞州波士顿的一家小型企业--草堆诊断公司的焦点。在本阶段1的目标1中 SBIR应用程序HayStack Diagnostics，Inc.将执行有限元模拟以设计不同的I-EMG 针状拓扑结构。这些针头将由FHC，Inc.以按服务收费的方式制造， (ME，Bowdoin)，这是一家我们以前与之合作过的公司，拥有定制针的专业知识 制造。在目标2中，我们将在体模介质(生理盐水和琼脂)中测试针头设计，并在 健康的野生型小鼠和肌萎缩侧索硬化症(ALS)小鼠。我们将评估EIM和EMG数据 独立地和共同地确定最有效和最健壮的设计，两者都是在可重复性方面 并在区分健康肌肉与病变肌肉时，与标准肌电进行比较，作为参考。在 这项工作的结论是，HaySTACK诊断公司将处于有利地位，进行第二阶段SBIR 寻求开发和测试I-EMG技术在各种神经肌肉疾病患者中的应用， 包括肌萎缩侧索硬化症。医学界和Natus Medical，Inc.表示了兴趣，世界上 最大的商业肌电制造商，我们相信，如果成功，HaySTACK诊断公司的技术 最终可以在临床神经肌肉疾病实践中得到广泛应用。

PROJECT SUMMARY Needle electromyography (EMG) remains the standard approach for assessing neuromuscular disease. While the technique has proven to be clinically valuable over the last 80 years, it has important limitations. These include its not being sensitive to alterations in muscle composition and structure, its inability to assess the contractile apparatus of muscle, and its subjective nature with an inter-rater reliability of only 60% and a specificity for disease of only 70%. One technology that could be incorporated seamlessly into the EMG needle to overcome its limitations is electrical impedance myography (EIM). By combining EIM and EMG into a single needle device there is the potential for greatly enhancing the accuracy of EMG, the clinical standard, ultimately yielding a “smarter EMG” technology to evaluate neuromuscular disorders. The development of this new “smarter EMG” technology has been termed needle impedance-electromyography (I-EMG) and it is the main focus of Haystack Diagnostics, Inc., a small business concern based in Boston, MA. In Aim 1 of this Phase 1 SBIR application, Haystack Diagnostics, Inc., will perform finite element simulations to design different I-EMG needles topologies. These needles will be then manufactured on a fee-for-service basis by FHC, Inc., (Bowdoin, ME), a company with which we have previously worked with expertise in custom needle manufacture. In Aim 2, we will test the needle designs in phantom media (saline and agar) and in groups of healthy, wild-type mice and amyotrophic lateral sclerosis (ALS) mice. We will evaluate the EIM and EMG data both independently and together to identify the most effective and robust design, both in terms of repeatability and in differentiating healthy from diseased muscle, comparing to standard EMG as a reference. At the conclusion of this work, Haystack Diagnostics, Inc., will be well positioned to pursue a Phase 2 SBIR application seeking to develop and test I-EMG technology in patients with a variety of neuromuscular diseases, including ALS. With expressed interest from the medical community and Natus Medical, Inc., the world’s largest commercial EMG manufacturer, we believe that if successful, Haystack Diagnostics, Inc., technology could ultimately find wide application in clinical neuromuscular disease practice.