HORNET Center for Autonomic Nerve Recording and Stimulation Systems (CARSS)

HORNET 自主神经记录和刺激系统中心 (CARSS)

• 批准号: 10557004
• 负责人: Raja Edward Hitti
• 金额: $ 60.7万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-23 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10557004
• 关键词: Abdomen; Accelerometer; Action Potentials; Address; Algorithms; Ally; Architecture; Autoimmune Diseases; Bladder; Bluetooth; Caliber; Cervical; Chronic; Clinical; Clinical Research; Colon; Colon Carcinoma; Colorectal; Communication; Constipation; Crohn' s disease; Custom; Development; Disease; Dyspepsia; Electrocardiogram; Electrodes; Epilepsy; FDA approved; Face; Fecal Incontinence; Gastrointestinal Motility; Gastroparesis; Head; Heart; Ileus; Individual; Inflammatory Bowel Diseases; Lead; Light Exercise; Lower urinary tract; Lung; Medicine; Mind; Modality; Monitor; Morphologic artifacts; Motion; Movement; Muscle; Nausea; Nerve; Obesity; Organ; Overactive Bladder; Pelvis; Physiologic pulse; Postoperative Period; Research Personnel; Rheumatoid Arthritis; Sacral nerve; Signal Transduction; Source; Stomach; Stroke; Substance Use Disorder; System; Technology; Temperature; Testing; Ulcerative Colitis; Withdrawal; autonomic nerve; base; bioelectronics; cell motility; electric impedance; flexibility; interest; mathematical ability; motility disorder; nerve supply; neuroregulation; obesity treatment; open source; operation; polydimethylsiloxane; signal processing; treatment-resistant depression; vagus nerve stimulation

Despite a wide-ranging interest in performing clinical research for bioelectronic medicine applications, there are no available open-architecture and open-source implantable systems for autonomic nerve stimulation and recording. As a result, clinical researchers face significant technical, regulatory, and financial hurdles in getting access to the implantable neuromodulation technologies that are required for performing these clinical studies. There are several clinical closed-loop implantable neuromodulation systems presently available and they have been helpful in supporting clinical research. However, in their current form, none are suitable for the bioelectronic medicine applications, as they lack key modules for accessing the autonomic nerves; moreover, many of them use closed architectures. To address this challenge, we propose to develop the implantable leads for the implantable pulse generator (IPG) platform, which will be based on a flexible, open-architecture, and modular approach. A large selection of stimulation and sensing leads will be developed for interfacing with the IPG header. Specifically, we will develop a polydimethylsiloxane-based cuff for stimulation of autonomic nerves with the diameter of 1 mm and larger. We will also develop a lead for sacral nerve stimulation. For enabling closed-loop neuromodulation, we will develop the leads for electrocardiographic, electromyographic, electroneurographic, and accelerometer-based motility sensing. Such flexibility and modularity will allow a significant degree of customization for different clinical indications, including open-loop and closed-loop IPG operation. Once the implantable leads are developed, they will be subjected to the benchtop testing.

尽管对对生物电子医学应用进行临床研究的兴趣广泛，但仍有 没有可用的开放式结构和开源植入系统用于自主神经刺激和 记录。结果，临床研究人员面临着重大的技术，法规和财务障碍 访问进行这些临床研究所需的可植入神经调节技术。 目前有几种可用的临床闭环神经调节系统 有助于支持临床研究。但是，以目前的形式，不适合生物电子 医学应用，因为它们缺少用于访问自主神经的关键模块；而且，其中许多 使用封闭的体系结构。 为了应对这一挑战，我们建议为植入式脉冲发生器开发可植入的潜在客户 （IPG）平台，该平台将基于灵活的开放式结构和模块化方法。大量选择 将开发刺激和传感导线，以与IPG标头接口。具体来说，我们将发展 基于聚二甲基硅氧烷的袖口，用于刺激直径为1 mm且较大的自主神经。我们 还将为萨克神经刺激发展带来铅。为了启用闭环神经调节，我们将发展 心电图，肌电图，电学和基于加速度计的运动能力的线索 感应。这种灵活性和模块化将允许对不同临床的大量自定义 指示，包括开环和闭环IPG操作。一旦开发了可植入的线索，他们就会 将进行台式测试。