Development and In Vivo Validation of a Theoretical Framework and Practical Methods to Improve Safety and Efficacy of Neuromodulation Electrodes

提高神经调节电极安全性和有效性的理论框架和实用方法的开发和体内验证

• 批准号: 10572029
• 负责人: Kip A Ludwig
• 金额: $ 114.63万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-01 至 2025-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10572029
• 关键词: Accounting; BRAIN initiative; Biocompatible Coated Materials; Charge; Chronic; Clinical; Corrosion; Data; Development; Dimensions; Electric Stimulation; Electrodes; Electrolytes; Environment; Equilibrium; Evaluation; Extravasation; Film; Fractals; Generations; Geometry; Goals; Hydrolysis; Implant; Implanted Electrodes; Injections; Lead; Location; Longevity; Measurement; Measures; Metals; Methods; Microelectrodes; Movement; Nature; Outcome; Patients; Physiologic pulse; Polymers; Quartz; Reaction; Research; Rodent; Safety; Surface; System; Techniques; Testing; Therapeutic Effect; Thinness; Time; Titanium; Treatment Efficacy; United States Food and Drug Administration; United States National Institutes of Health; Validation; Water; Width; chemical reaction; cytotoxic; density; design; electric impedance; experimental study; improved; in vivo; instrumentation; iridium oxide; minimally invasive; neuroregulation; next generation; novel; phenomenological models; prevent; safety testing; surface coating

Despite widespread clinical use, the theoretical framework by which to understand safety of electrical stimulation through implanted electrodes is surprisingly limited. Most of our current understanding of stimulation safety was phenomenologically determined in the 80s and 90s using very limited electrode geometries, materials, stimulation systems, and stimulation locations. Current benchtop testing of electrode safety to support submissions to the Food and Drug Administration (FDA) is predominantly focused on identifying the applied charge density that drives the hydrolysis of water at the electrode/electrolyte interface. In this proposal, we seek to validate, optimize, and distribute a benchtop testing framework that more accurately predicts chronic in-vivo safety issues. This framework is extensible to coated microelectrode designs, including high-density and/or thin-film arrays, as well as to novel stimulation waveforms – both of which are critically enabling for next-generation minimally invasive neuromodulation therapies.

尽管广泛的临床应用，理论框架，以了解通过植入电极的电刺激的安全性是令人惊讶的有限。我们目前对刺激安全性的大多数理解是在80年代和90年代使用非常有限的电极几何形状、材料、刺激系统和刺激位置从现象学上确定的。目前支持向美国食品药品监督管理局（FDA）提交的电极安全性台架测试主要集中在确定驱动电极/电解质界面处水水解的施加电荷密度。在本提案中，我们寻求验证、优化和分发一个更准确地预测慢性体内安全性问题的台式测试框架。该框架可扩展到涂层微电极设计，包括高密度和/或薄膜阵列，以及新型刺激波形-这两者都是下一代微创神经调节治疗的关键。