Deep Brain Stimulation Array for Neuromodulation

描述（由申请人提供）：脑深部电刺激（DBS）设备-“脑起搏器”-已成为治疗神经系统疾病的革命性新方法。DBS治疗使用通过具有多个电极触点的可植入导线递送到特定脑深部结构的可控电刺激。DBS目前是晚期帕金森病的治疗选择，并被批准用于特发性震颤、肌张力障碍和强迫症。目前正在调查抑郁症、慢性植物人状态、肥胖症和痴呆症。创新DBS电极导线和下一代DBS系统具有临床需求和重要的商业机会，可提供增强的靶向、刺激选择性和调谐以及MR安全性。NeuroNexus之前已经开发并证明了创新的MR安全DBS电极导线（脑深部电刺激阵列，或DBSA）的可行性，用于脑深部靶点的精确，选择性和可调治疗电刺激。拟议的II期SBIR项目旨在将DBSA进一步开发为经过充分验证的临床级DBS电极导线，在该项目结束时，将进行临床评价，然后进行商业化。本项目将由NeuroNexus指导，并在MPI Research，Inc.进行临床前试验。和密歇根大学。项目结构遵循临床产品的标准产品开发过程，以符合设计控制和测试的法规要求。本项目的明确目标是完成准备IDE提交所需的所有开发、验证和确认阶段，以获得FDA许可，开始DBSA的初始临床试验。该项目的技术创新集中在使用先进的微加工电极技术来创建先进的临床DBS电极导线，该电极导线具有以安全有效的方式向深部脑靶点提供治疗刺激模式的能力。该项目将产生一种创新的临床级DBS电极导线，该电极导线将作为下一代DBS系统的一部分进行商业化，并成为神经科学研究的创新研究产品。通过这样做，该项目将增加尖端神经技术对改善和推进美国和全球市场重大神经系统疾病治疗的影响。 公共卫生相关性：脑深部电刺激（DBS）设备-“脑起搏器”-最近已经成为一种令人兴奋的新型神经技术，用于治疗严重的运动障碍，如帕金森病和原发性震颤。本项目将开发第二代DBS电极系统，与当前临床批准的DBS电极系统相比，该系统将提供显著的性能改进。通过改善接受DBS治疗的患者的护理和生活质量，预计该项目将产生显著的社会效益。

DESCRIPTION (provided by applicant): Deep Brain Stimulation (DBS) devices - 'brain pacemakers' - have emerged as a revolutionary new approach to the treatment of neurological disorders. DBS therapy uses controllable electrical stimulation delivered to specific deep brain structures through an implantable lead having multiple electrode contacts. DBS is currently the treatment of choice for late-stage Parkinson's Disease and is approved for essential tremor, dystonia, and obsessive-compulsive disorder. It is under investigation for depression, chronic vegetative state, obesity, and dementia. There is a clinical need-and significant commercial opportunity-for innovative DBS leads and next-generation DBS systems that provide enhanced targeting, stimulation selectivity and tuning, and MR- safety. NeuroNexus has previously developed and demonstrated feasibility of an innovative MR-safe DBS lead (the Deep Brain Stimulation Array, or DBSA) for precise, selective, and tunable therapeutic electrical stimulation of deep brain targets. The proposed Phase II SBIR project is directed at further development of the DBSA to a fully validated, clinical-grade DBS lead that, at the end of this project, will be positioned for clinical evaluation and then commercialization. This project will be directed by NeuroNexus with pre-clinical testing conducted at MPI Research, Inc. and the University of Michigan. The project structure follows a standard product development process for clinical products to comply with regulatory requirements for design controls and testing. The explicit goal of this project is to complete all development, verification, and validation stages that are required to prepare an IDE submission to gain FDA permission to commence the initial clinical trial for the DBSA. The technical innovation of the project centers on the use of advanced microfabricated electrode technology to create an advanced clinical DBS lead that has increased capabilities for delivering therapeutic stimulation patterns to deep brain targets in a safe and efficacious manner. This project will result in an innovative, clinical-grade DBS lead that will be positioned for commercialization as part of a next-generation DBS system, as well as an innovative research product for neuroscience research. In so doing, this project will increase the impact of leading-edge neurotechnology on improving and advancing treatments of significant neurological disorders in the US and global markets. PUBLIC HEALTH RELEVANCE: Deep brain stimulation (DBS) devices - 'brain pacemakers' - have recently emerged as an exciting novel neurotechnology for treating severe movement disorders, such as Parkinson's disease and Essential Tremor. This project will develop a 2nd-generation DBS electrode system that will provide significant performance improvements over the current clinically approved DBS electrode system. There is expected to be a significant societal benefit of this project through improved care and quality of life for patients receiving DBS therapies.