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.

项目总结/摘要 非侵入性脑刺激（NIBS）在认知神经科学中引起了相当大的兴趣 社区，提供了一个重要的基础研究工具，研究大脑功能，与新兴的临床应用 以恢复神经系统疾病患者的功能。尽管有这种潜力，但一种新兴的文学 强调了对经颅电刺激（tES）的可靠性和稳健性的担忧， NIBS方法用于通过应用阈下刺激诱导脑可塑性的变化。 这些问题可能与tES系统只能诱导适度电场（E场）的事实有关。 考虑到安全性/公差问题限制了可以输送的tES刺激强度， 在头皮上。我们开发了一种全新的NIBS方法，其中神经元的阈下调制 通过kHz频率的振荡磁场产生可激发性。该系统称为kTMP (kHz经颅磁扰动）显著增加了阈下电场感应的范围， 通过调制kHz载波频率的包络，可以在生理相关的电场 频率. 受试者的具体目的是比较kTMP与两种传统NIBS的疗效 技术：tES和TMS。这一比较是建立NIBS神经科学中kTMP的基础 社区作为更有效和可靠的方法来促进我们对大脑功能的理解， 治疗神经系统疾病的翻译工具。该项目的参与者将是一个重要的 朝着FDA批准kTMP的最终目标迈进了一步。此外，在Avania的支持下， 在推进医疗技术方面，该公司还将致力于制定kTMP的监管路径， 用于中风后恢复。 到第二年年底，学员将学会如何进行研究性学习 独立地获得了三种NIBS方法的现有技术和实践方面的知识， 获得了FDA法规和医疗器械上市流程的广泛概述。