Deep Brain Stimulation Array for Neuromodulation

描述（由申请人提供）：脑深部刺激（DBS）设备——“大脑起搏器”——已经成为治疗神经系统疾病的一种革命性的新方法。DBS疗法通过具有多个电极接触的可植入导线对特定的脑深部结构进行可控电刺激。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。目前正在对抑郁症、慢性植物人状态、肥胖和痴呆进行研究。创新的DBS导联和下一代DBS系统具有临床需求和重要的商业机会，这些系统可提供增强的靶向性、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一种创新的核磁共振安全DBS引线（深部脑刺激阵列，或DBSA）的可行性，用于对深部脑目标进行精确、选择性和可调的治疗性电刺激。拟议的II期SBIR项目旨在进一步开发DBSA，使其成为完全验证的临床级DBS先导物，在该项目结束时，将定位于临床评估，然后商业化。该项目将由NeuroNexus指导，并由MPI Research， Inc.和密歇根大学进行临床前测试。项目结构遵循临床产品的标准产品开发流程，以符合设计控制和测试的法规要求。该项目的明确目标是完成准备IDE提交所需的所有开发、验证和验证阶段，以获得FDA批准开始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制造电极技术来制造先进的临床DBS引线，该引线具有以安全有效的方式向深部脑目标提供治疗性刺激模式的能力。该项目将产生一种创新的临床级DBS先导物，作为下一代DBS系统的一部分，该先导物将被定位为商业化，同时也是神经科学研究的一种创新研究产品。通过这样做，该项目将增加尖端神经技术在改善和推进美国和全球市场重大神经疾病治疗方面的影响。

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.