Improving ALS Diagnosis using Needle I-EMG

使用针 I-EMG 改善 ALS 诊断

基本信息

批准号：
9905446
负责人：
Elmer C Lupton
金额：
$ 22.5万
依托单位：
HAYSTACK DIAGNOSTICS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-30 至 2021-03-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9905446
关键词：
Adult Affect Agar Age Amyotrophic Lateral Sclerosis Animals Anisotropy Area Atrophic Bilateral Boston Businesses Cachexia Cessation of life Characteristics Clinical Clinical Trials Collaborations Communities Custom Data Data Collection Data Quality Deposition Development Devices Diagnosis Diagnostic Disease Early Diagnosis Electrodes Electromyography Electrophysiology (science)Electrostatics Elements Engineering Evaluation Fatty acid glycerol esters Fee-for-Service Plans Future Harvest Histologic Human Industrialization Israel Letters Manufacturer Name Measurement Measures Medical Medical center Methods Modeling Monitor Mus Muscle Muscle Fibers Myography Myopathy Nature Needles Neuromuscular Diseases Outcome Patients Peripheral Nervous System Phase Physicians Positioning Attribute Process Radiculopathy Reproducibility Rest Riluzole Saline Sampling Shapes Signal Transduction Skin Small Business Innovation Research Grant Specificity Speed Standardization Sterilization Structure Surface Symptoms System Techniques Technology Testing Therapeutic Wild Type Mouse Work base biomaterial compatibility design disability electric impedance electrical property experimental study improved insight interest nervous system disorder novel phase 2 study quadriceps muscle sarcopenia simulation subcutaneous tool

项目摘要

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.

项目摘要针头肌电图（EMG）仍然是评估神经肌肉疾病的标准方法。尽管在过去的80年中，该技术在临床上有价值，它具有重要的局限性。这些包括对肌肉组成和结构的改变不敏感，无法评估肌肉的收缩仪器及其主题性质仅为60％，A 疾病的特异性仅为70％。一项可以无缝合并到EMG针的技术要克服其局限性是电阻止myagraphy（EIM）。通过将EIM和EMG合并为一个针头设备有可能大大提高临床标准EMG的准确性，最终产生一种“更聪明的EMG”技术来评估神经肌肉疾病。这个新的发展 “智能EMG”技术已被称为针阻抗 - 电镜像（I-EMG），它是主要的 Haystack Diagnostics，Inc。的重点，这是位于马萨诸塞州波士顿的小型企业问题。在此阶段1的AIM 1中 Haystack Diaginostics，Inc。SBIR应用程序将执行有限元模拟来设计不同的I-EMG 针拓扑。然后，这些针头将由FHC，Inc. （鲍登，我）生产。在AIM 2中，我们将在Phantom介质（盐水和琼脂）中测试针头设计健康的野生型小鼠和肌萎缩性侧索硬化症（ALS）小鼠。我们将评估EIM和EMG数据在重复性方面，独立和共同确定最有效，最强大的设计并将其与患病的肌肉区分开来，将标准EMG作为参考。在这项工作的结论，Haystack Diagnostics，Inc。将有能力追求第二阶段SBIR 寻求在各种神经肌肉疾病的患者中开发和测试I-EMG技术的应用程序，包括ALS。凭借医学界和Natus Medical，Inc。的兴趣，世界的兴趣最大的商业EMG制造商，我们认为，如果成功，Haystack Diagnostics，Inc。，技术最终可以在临床神经肌肉疾病实践中找到广泛的应用。

项目成果

期刊论文数量（8）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Electrical impedance myography: A critical review and outlook.

DOI：
10.1016/j.clinph.2020.11.014
发表时间：
2021-03
期刊：
Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology
影响因子：
0
作者：
Sanchez B;Martinsen OG;Freeborn TJ;Furse CM
通讯作者：
Furse CM

In vivo muscle conduction study of the tongue using a multi-electrode tongue depressor.

DOI：
10.1016/j.clinph.2020.11.010
发表时间：
2021-03
期刊：
Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology
影响因子：
0
作者：
Luo X;Gutierrez Pulido HV;Rutkove SB;Sanchez B
通讯作者：
Sanchez B

In silicomuscle volume conduction study validatesin vivomeasurement of tongue volume conduction properties using a user tongue array depressor.

在硅肌体积传导研究中，验证了使用用户舌阵列抑制器对舌体积传导特性的体内测量。

DOI：
10.1088/1361-6579/abed36
发表时间：
2021
期刊：
Physiological measurement
影响因子：
3.2
作者：
Luo,Xuesong;Sanchez,Benjamin
通讯作者：
Sanchez,Benjamin

Skin Electrical Resistance as a Diagnostic and Therapeutic Biomarker of Breast Cancer Measuring Lymphatic Regions.

DOI：
10.1109/access.2021.3123569
发表时间：
2021
期刊：
IEEE access : practical innovations, open solutions
影响因子：
0
作者：
Andreasen N;Crandall H;Brimhall O;Miller B;Perez-Tamayo J;Martinsen OG;Kauwe SK;Sanchez B
通讯作者：
Sanchez B

Nonhomogeneous volume conduction effects affecting needle electromyography: an analytical and simulation study.