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

PFI：AIR-TT：从实验室到市场 - 经颅局灶性电刺激 (TFS) 治疗癫痫

• 批准号: 1701049
• 负责人: Walter Besio
• 金额: $ 20万
• 依托单位: University of Rhode Island
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-15 至 2021-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1701049&HistoricalAwards=false
• 关键词: PFI; AIR; TT; Lab; Market

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.

该 PFI：AIR 技术翻译项目专注于翻译非侵入性经颅局灶性电刺激 (TFS)，以满足治疗难治性癫痫的需求​TFS 技术很重要，因为它将提供一个可供研究使用的强大工具。和医学界理解和调节大脑活动，并在帮助癫痫和其他神经和精神疾病患者的广泛技术领域具有广泛的适用性。该项目将产生强大而有力的成果。易于使用的临床 TFS 原型具有以下独特功能：它是非侵入性的、局部的，并且允许从同一电极进行记录和刺激。这些功能将有助于简化和推进癫痫的治疗方式并避免风险。​该项目在从研究发现转向商业应用的过程中解决了以下技术差距。​首先，将改进 TFS 原型的设计以满足安全和操作要求。其次，TFS 的安全性和耐受性将通过首次人体测试来确定，这种创新的临床 TFS 原型将完全可编程，电流强度（0 至 100 mA）增量为 2 mA，脉冲宽度。 （50 至 500 微秒）以 10 微秒为增量，频率（0 至 500 Hz）以 5 Hz 为增量，持续时间脉冲（30 秒到 30 分钟），增量为 30 秒​控制器将确保所选的刺激参数低于能量密度因子 0.92 A2/cm4-sec-1，这对于电热耦合来说是安全的。此外，直接参与该项目的研究生将通过 TFS 原型的设计和测试经验获得创新和技术转化，该项目还聘请了业务开发和知识产权专业人士来提供帮助。在这项从研究发现到商业现实的技术转化工作中实现商业化目标。