Development of an Implantable Trigeminal Nerve Stimulation System for Drug Resist

描述（由申请人提供）：癫痫影响着300万美国人和全世界5000万人。耐药癫痫（DRE）影响到所有癫痫患者的三分之一以上，并可能导致失业、受伤和死亡。三叉神经刺激（TNS）是一种新兴的DRE神经调节治疗方法，与其他技术相比具有独特的优势。TNS可以双侧、高频、体外或皮下给予，具有良好的安全性和有效性。TNS的独特之处在于能够在植入永久性皮下系统（sTNS）之前识别外部TNS （eTNS）的应答者。我们最近在50名DRE患者中完成了首次外部TNS （eTNS）随机对照试验（RCT）。40%（40.5%）的患者在18周时癫痫发作频率降低了50%以上，情绪也有了显著改善（贝克抑郁量表）。这项人体临床试验为TNS在DRE中的概念提供了强有力的证据。这个SBIR转化研究项目的目的是开发一种植入式皮下三叉神经刺激系统（sTNSTM）治疗DRE。该项目建立在NeuroSigma在外部三叉神经系统（eTNSTM）方面的经验基础上，该项目于2011年获得了STTR。这个SBIR汇集了一个独特的团队生物医学工程师，神经科学家和神经外科医生在三叉神经刺激的发展开创性的经验。此外，我们计划与领先的颅内电极制造商Stellar Technologies和自1969年以来备受尊敬的植入式脉冲发生器和组件制造商CCC合作，后者已同意修改现有的多通道IPG，以满足NeuroSigma对sTNS的独特设计规范。

DESCRIPTION (provided by applicant): Epilepsy affects three million Americans and fifty million people worldwide. Drug resistant epilepsy (DRE) affects over one third of all people with epilepsy, and may lead to unemployment, injury, and death. Trigeminal Nerve Stimulation (TNS) is an emerging neuromodulation therapy for DRE, which has unique advantages over other techniques. TNS can be delivered bilaterally, at high frequencies, and externally or subcutaneously with excellent safety and efficacy. Unique to TNS is the ability to identify responders with external TNS (eTNS) prior to implantation with a permanent subcutaneous system (sTNS). We have recently completed the first-ever randomized control trial (RCT) of external TNS (eTNS") in 50 subjects with DRE. Forty percent (40.5 percent) experienced greater than 50 percent reduction in seizure frequency at 18 weeks, with significant improvements in mood (Beck Depression Inventory). This human clinical trial provides strong evidence for proof of concept of TNS in DRE. The purpose of this SBIR translational research project is to develop an implantable subcutaneous Trigeminal Nerve Stimulation System (sTNSTM) for the treatment of DRE. This project builds upon NeuroSigma's experience in external Trigeminal Nerve System (eTNSTM) for which it was awarded an STTR in 2011. This SBIR brings together a unique team of biomedical engineers, neuroscientists and neurosurgeons with seminal experience in the development of Trigeminal Nerve Stimulation. Furthermore, we plan to collaborate with Stellar Technologies, a leading manufacturer of intracranial electrodes, and CCC, a respected manufacturer of implantable pulse generators and components since 1969, who has agreed to modify an existing multichannel IPG which meets NeuroSigma's unique design specifications for sTNS.