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.

尽管临床应用广泛，但理解植入电极电刺激安全性的理论框架却出人意料地有限，目前我们对刺激安全性的理解大多是在 80 年代和 90 年代使用非常有限的电极几何形状、材料、刺激系统从现象学角度确定的。目前用于支持向食品和药物管理局 (FDA) 提交的电极安全性台式测试主要集中于确定驱动电极/电解质界面处的水水解的所施加的电荷密度。根据提案，我们寻求验证、优化和分发一个台式测试框架，该框架可以更准确地预测长期体内安全问题，该框架可扩展到涂层微电极设计，包括高密度和/或薄膜阵列以及微电极设计。到新颖的刺激波形——这两者都对下一代微创神经调节疗法至关重要。