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: 10706618
• 负责人: Raja Edward Hitti
• 金额: $ 63.53万
• 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/10706618
• 关键词: Abdomen; Accelerometer; Action Potentials; Address; Algorithms; Ally; Architecture; Autoimmune Diseases; Bladder; Bluetooth; Cervical; Chronic; Clinical; Clinical Research; Colon; Colon Carcinoma; Colorectal; Communication; Constipation; Crohn' s disease; Darkness; Dedications; Development; Diameter; Disease; Dyspepsia; Electrocardiogram; Electrodes; Electromyography; Epilepsy; FDA approved; Face; Fecal Incontinence; Gastrointestinal Motility; Gastroparesis; Heart; Ileus; Implant; Individual; Inflammatory Bowel Diseases; Lead; Light Exercise; Lower urinary tract; Lung; Medicine; 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; Stomach; Stroke; Substance Use Disorder; System; Technology; Temperature; Testing; Ulcerative Colitis; Withdrawal; autonomic nerve; 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.

尽管人们对生物电子医学应用的临床研究有着广泛的兴趣，但 没有可用的开放架构和开源植入系统用于自主神经刺激和 记录。因此，临床研究人员在获得药物方面面临着重大的技术、监管和财务障碍。 获得进行这些临床研究所需的植入式神经调节技术。 目前有几种临床闭环植入式神经调节系统可用，它们具有 有助于支持临床研究。然而，就目前的形式而言，没有一个适合生物电子学 医学应用，因为它们缺乏访问自主神经的关键模块；此外，他们中的许多人 使用封闭式架构。 为了应对这一挑战，我们建议开发用于植入式脉冲发生器的植入式引线 (IPG) 平台，该平台将基于灵活、开放式架构和模块化方法。大量的选择 将开发刺激和传感引线用于与 IPG 接头连接。具体来说，我们将开发 用于刺激自主神经的聚二甲基硅氧烷袖带，直径为 1 毫米及以上。我们 还将开发用于刺激骶神经的导线。为了实现闭环神经调节，我们将开发 心电图、肌电图、神经电图和基于加速度计的运动的引线 传感。这种灵活性和模块化将允许针对不同的临床进行显着程度的定制。 适应症，包括开环和闭环 IPG 操作。一旦开发出可植入导线，它们 将接受台式测试。