Exploring the Parameter Space of High Frequency Magnetic Perturbation in Manipulating Neural Excitability and Plasticity.

探索高频磁扰动操纵神经兴奋性和可塑性的参数空间。

• 批准号: 10841060
• 负责人: Ludovica Labruna
• 金额: $ 9.75万
• 依托单位: MAGNETIC TIDES, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-15 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10841060
• 关键词: Area; Basic Science; Brain; Cephalic; Clinical; Communities; Electric Stimulation; Frequencies; Goals; Human; Individual; Knowledge; Learning; Literature; Magnetism; Marketing; Medical; Medical Device; Medical Technology; Methods; Neurosciences; Physiological; Process; Regulation; Safety; Scalp structure; Surface; System; Techniques; clinical application; cognitive neuroscience; comparative efficacy; electric field; functional restoration; interest; magnetic field; nervous system disorder; neural; noninvasive brain stimulation; novel; post stroke; research study; stroke recovery; stroke rehabilitation; tool

Project Summary/Abstract Non-invasive brain stimulation (NIBS) has attracted considerable interest in the cognitive neuroscience community, providing an important basic research tool to study brain function, with emerging clinical applications to restore function in individuals with neurological disorders. Despite this potential, an emerging literature has highlighted concerns regarding the reliability and robustness of transcranial electric stimulation (tES), the primary NIBS method used to induce changes in brain plasticity through the application of subthreshold stimulation. These problems are likely related to the fact that tES systems can only induce modest electrical fields (E-field) at the cortical surface given that safety/tolerance issues limit the intensity of tES stimulation that can be delivered at the scalp. We developed a radically new NIBS approach, one in which subthreshold modulation of neural excitability is brought about via oscillating magnetic fields at kHZ frequencies. This system, referred to kTMP (kHz Transcranial Magnetic Perturbation) significantly increases the range of subthreshold E-field induction, and through modulation of the envelope of the kHz carrier frequency, can impose E-fields at physiological relevant frequencies. The specific aims of the supplementee is to compare the efficacy of kTMP with two conventional NIBS techniques: tES and TMS. This comparison is fundamental to establish kTMP in the NIBS neuroscience community as more efficient and reliable method to advance our understanding of brain function and as translational tool for the treatment of neurological disorders. The project of the supplementee will be an important step towards the end goal of FDA approval of kTMP. Moreover, supported by Avania, an organization specialized in advancing medical technologies, the supplementee will be also working on the regulatory path for kTMP to be used for post-stroke recovery. By the end of the second year the supplementee will have learned how to conduct research studies independently, gained knowledge on the existing technical and practical aspects of the three NIBS methods, and obtained a broad overview of the FDA regulations and processes to market a medical device.

项目摘要/摘要 非侵入性大脑刺激（NIB）对认知神经科学引起了极大的兴趣 通过新兴的临床应用，社区提供了研究大脑功能的重要基础研究工具 恢复神经系统疾病患者的功能。尽管有潜力，但新兴文学已经 强调了对经颅电刺激（TE）的可靠性和鲁棒性的关注， NIBS方法用于通过应用亚阈值刺激来诱导大脑可塑性的变化。 这些问题可能与TES系统只能诱导适中的电场（电子场）有关 在皮质表面，鉴于安全/公差问题限制了可以传递的TES刺激强度 在头皮上。我们开发了一种新的NIBS方法，其中一种神经的子阈值调节 兴奋性是通过kHz频率振荡的磁场引起的。该系统，提到KTMP （KHz经颅磁扰动）显着增加了亚阈值电子场诱导的范围，并且 通过调节KHz载体频率的信封，可以将电子场施加在生理上 频率。 补充剂的具体目的是将KTMP的功效与两个常规NIB进行比较 技术：TES和TMS。这种比较是在NIBS神经科学中建立KTMP的基础 社区是更有效，更可靠的方法，以提高我们对大脑功能的理解和 治疗神经系统疾病的翻译工具。补充人的项目将是一个重要的 迈向FDA批准KTMP的最终目标。此外，由专业组织Avania的支持 在推进医疗技术时，补充人还将为KTMP的监管途径致力于 用于冲程后恢复。 到第二年结束时，补充人将学习如何进行研究 独立地获得了三种NIB方法的现有技术和实际方面的知识，以及 获得了FDA法规和流程以销售医疗设备的广泛概述。