Development of an Implantable Trigeminal Nerve Stimulation System for Drug Resist

描述(申请人提供)：癫痫影响三百万美国人和全球五千万人。耐药癫痫(DRE)影响超过三分之一的癫痫患者，并可能导致失业、受伤和死亡。三叉神经刺激(TNS)是治疗DRE的一种新兴的神经调节疗法，与其他治疗方法相比具有独特的优势。TNS可通过双侧、高频、体外或皮下给药，具有极好的安全性和有效性。TNS的独特之处在于，在植入永久性皮下系统(STNS)之前，能够识别具有外部TNS(ETNS)的应答者。我们最近完成了首次外部TNS(ETNS)的随机对照试验(RCT)，试验对象为50名DRE患者。40%(40.5%)在18周时癫痫发作频率减少超过50%，情绪显著改善(贝克抑郁量表)。这项人类临床试验为DRE的TNS概念提供了强有力的证据。这项SBIR翻译研究项目的目的是开发一种用于治疗DRE的植入性三叉神经皮下刺激系统(STNSTM)。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，因此它在2011年获得了STTR奖。SBIR汇集了一支由生物医学工程师、神经科学家和神经外科医生组成的独特团队，他们在三叉神经刺激开发方面具有开创性的经验。此外，我们计划与领先的颅内电极制造商Stella Technologies和自1969年以来一直受人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针对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.