Sympathetic Nerve Activity Recorded From the Skin and Cardiac Arrhythmias

描述（由申请人提供）：本研究项目的广泛和长期目标是使用，开发和销售一种使用皮肤电极同时记录交感神经活动（SNA）和心电图（ECG）的仪器。这种方法（neuECG）是陈博士在克兰纳特心脏病研究所的研究实验室发现的，印第安纳大学已经申请了专利。心律失常技术有限责任公司是为了进一步推进这一概念而开发的，我们认为，通过提供一种新的无创心律失常预测和检测工具，neuECG具有重要的商业价值。交感神经张力在心律失常发生中起重要作用。心率变异性分析和微神经造影记录是评估交感神经张力的标准技术。然而，这些技术有很多限制。这种新型心电图是为了在人体皮肤上同时记录心电图和神经活动而研制的。在与陈博士实验室的合作中，我们已经在人类患者中获得了强有力的初步结果，以记录正常志愿者和术后房颤和电风暴患者的新心电图的成功记录。在这些初步研究中，新心电图记录的电信号与SNA一致，SNA与心率加速、心房颤动和室性心律失常相关。我们建议新心电图可作为预测心律失常和心源性猝死的一种新的诊断工具。此外，它可能有助于周围神经疾病的诊断

DESCRIPTION (provided by applicant): The broad and long-term objective of this research project is to use, develop and market an instrument for the simultaneous recording of sympathetic nerve activity (SNA) and electrocardiogram (ECG) using electrodes on the skin. This method (neuECG) was discovered in Dr. Chen's research laboratory at the Krannert Institute of Cardiology, and a patent application has been filed by Indiana University. Arrhythmotech LLC was developed to further advance this concept and we propose that neuECG has a significant commercial value by providing a new non-invasive tool for arrhythmia prediction and detection. Sympathetic tone is important in cardiac arrhythmogenesis. Heart rate variability analyses and microneurography recordings are standard techniques to assess sympathetic tone. However, these techniques have multiple limitations. The neuECG was developed to record ECG and nerve activity simultaneously on the skin of human subjects. In collaboration with Dr. Chen's lab, we have obtained strong preliminary results in human patients to document the successful recording of neuECG in normal volunteers and in patients with postoperative atrial fibrillation and electrical storm. In these preliminary studies, neuECG recording showed electrical signals consistent with SNA, and that the SNA correlated with heart rate acceleration, atrial fibrillation and ventricular arrhythmias. We propose that the neuECG may serve as a new diagnostic tool for the prediction of cardiac arrhythmias and sudden cardiac death. In addition, it may be helpful in the diagnosis of diseases involving the peripheral nervous system, such as neuromuscular diseases. In this Phase 1 application, we have designed two clinical studies to document the feasibility and utility of neuECG recording in normal volunteers and in patients with cardiac arrhythmias. Once this is complete, we will immediately apply for Phase 2 funding to commercialize the neuECG for human use. Specific Aim 1: To record simultaneous ECG and SNA in normal volunteers and correlate the nerve activity to heart rate. We will consent normal volunteers for this study. We will place ECG electrodes on the skin using standard limb lead and chest lead configurations. The signals are digitized and filtered to record ECG and SNA simultaneously. After baseline recordings, the patients will undergo 2-min cold water immersion test, followed by Valsalva maneuver. The data will be analyzed to test the hypothesis that it is feasible to simultaneously record SNA from the skin, and that SNA recordings correlate with heart rate acceleration in normal volunteers. Specific Aim 2: To record simultaneous ECG and SNA in patients with cardiac arrhythmias and correlate an increase in nerve activity to arrhythmia onset. We will perform continuous neuECG recording at the bedside in patients with recurrent cardiac arrhythmias. The data will be analyzed to determine if the SNA are present on the skin of the diseased patients, and if the SNA correlates with the onset of cardiac arrhythmias. The results will be used to test the hypothesis that a continuous neuECG recording is feasible in patients with heart diseases, and that SNA predicts the impending onset of cardiac arrhythmias.