PFI:AIR-TT: From Lab to Market - Transcranial Focal Electrical Stimulation (TFS) for Epilepsy

这个PFI: AIR技术翻译项目的重点是翻译非侵入性经颅局灶性电刺激（TFS），以填补治疗难治性癫痫的需要。TFS技术很重要，因为它将提供一个强大的工具，供研究和医学界了解和调节大脑活动，并在广泛的技术领域广泛适用，以帮助癫痫和其他一般神经和精神疾病患者。该项目将产生一个强大且易于使用的临床TFS原型。TFS具有以下独特的特点：它是非侵入性的，局部的，并且允许从相同的电极记录和刺激。这些特点将有助于简化和推进癫痫的治疗方式，避免植入刺激器的风险或抗癫痫药物的副作用。该项目解决了以下技术差距，因为它从研究发现转化为商业应用。首先，将改进TFS原型的设计，以满足临床环境的安全和操作要求。其次，TFS的安全性和耐受性将通过首次人体试验来确定。这种创新的临床TFS原型将完全可编程，电流强度（0至100 mA）以2 mA为增量，脉冲宽度（50至500微秒）以10微秒为增量，频率（0至500赫兹）以5赫兹为增量，脉冲持续时间（30秒至30分钟）以30秒为增量。控制器将确保所选择的刺激参数低于能量密度因子0.92 A2/ cm2 -sec-1，通过电-热耦合场分析和初步动物实验发现，该参数是安全的。此外，直接参与该项目的研究生将通过TFS原型的设计和测试获得创新和技术翻译经验。该项目涉及业务开发和知识产权专业人员，以帮助实现从研究发现到商业现实的技术转化工作的商业化目标。

This PFI: AIR Technology Translation project focuses on translating non-invasive transcranial focal electrical stimulation (TFS) to fill the need for the treatment of refractory epilepsy.   The TFS technology is important because it will provide a powerful tool that is accessible to the research and medical community for understanding and modulating brain activities and has extensive applicability in the broad space of technologies to aid persons with epilepsy and other neurological and psychiatric disorders in general.  The project will result in a robust and easy-to-use clinical TFS prototype. TFS has the following unique features: it is non-invasive, focal, and allows recording and stimulation from the same electrodes. These features will help simplify and advance the therapeutic modality for epilepsy and avoid the risks involved with implantable stimulators or the side effects of antiepileptic drugs.  This project addresses the following technology gaps as it translates from research discovery toward commercial application.  First, the design of the TFS prototype will be improved to meet the safety and operational requirements of the clinical environment.  Second, the safety and tolerability of TFS will be established through first-in-human testing.  This innovative clinical TFS prototype will be fully programmable with current intensity (0 to 100 mA) in increments of 2 mA, pulse width (50 to 500 micro-sec) in increments of 10 micro-sec, frequency (0 to 500 Hz) in increments of 5 Hz, and duration of pulses (30 seconds to 30 minutes) in increments of 30 seconds.  The controller will assure the stimulation parameters selected are below the energy density factor, 0.92 A2/cm4-sec-1, which was found to be safe with electrical-thermal coupled field analysis and preliminary animal experiments. In addition, the graduate student directly involved in this project will receive innovation and technology translation experiences through the design and testing of the TFS prototype. This project engages business development and intellectual property professionals to help achieve the commercialization goal in this technology translation effort from research discovery toward commercial reality.