Deep Brain Stimulation Array for Neuromodulation

用于神经调节的深部脑刺激阵列

• 批准号: 8514084
• 负责人: RIO J VETTER
• 金额: $ 107.71万
• 依托单位: NEURONEXUS TECHNOLOGIES
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-08-01 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8514084
• 关键词: Adverse effects; Animal Model; Animal Testing; Animals; Authorization documentation; Brain; Caring; Characteristics; Clinical; Clinical Research; Clinical Trials; Data; Deep Brain Stimulation; Dementia; Development; Devices; Dysarthria; Dystonia; Electric Stimulation; Electrodes; Essential Tremor; Experimental Models; Face; Frequencies; Generations; Goals; Grouping; Intractable Epilepsy; Investigation; Laboratory Research; Lead; Marketing; Mental Depression; Michigan; Microfabrication; Modeling; Moods; Movement Disorders; Neurosciences Research; Obesity; Obsessive-Compulsive Disorder; Outcome; Pacemakers; Parkinson Disease; Patients; Pattern; Performance; Phase; Physiologic pulse; Positioning Attribute; Primates; Process; Qualifying; Quality Control; Quality of life; Research; Resolution; Safety; Sales; Series; Shapes; Signal Transduction; Site; Small Business Innovation Research Grant; Staging; Structure; System; Technology; Testing; Therapeutic; Tissues; Universities; Validation; Vegetative States; biomaterial compatibility; chronic depression; cognitive change; commercialization; cost effective; deep brain stimulation array; design; experience; flexibility; improved; innovation; manufacturing process; meetings; nervous system disorder; neural circuit; neuroregulation; neurotechnology; next generation; novel; novel strategies; pre-clinical; product development; programs; prototype; relating to nervous system; research clinical testing; simulation; verification and validation

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.

描述(申请人提供)：脑深部刺激(DBS)设备-脑起搏器-已经成为治疗神经疾病的一种革命性的新方法。DBS疗法使用可控的电刺激，通过具有多个电极接触的可植入导线传递到特定的大脑深层结构。DBS目前是晚期帕金森病的首选治疗方法，并被批准用于特发性震颤、肌张力障碍和强迫症。它正在接受抑郁症、慢性植物人状态、肥胖症和痴呆症的研究。创新的DBS导联和下一代DBS系统具有更强的靶向性、刺激选择性和调谐以及MR安全性，因此临床上存在需求，也存在巨大的商业机会。NeuroNexus之前已经开发并证明了一种创新的MR安全的DBS导联(脑深部刺激阵列，或DBSA)的可行性，用于对大脑深部靶点进行精确、选择性和可调的治疗性电刺激。拟议的第二阶段SBIR项目旨在将DBSA进一步发展为经过充分验证的临床级DBS领导，在该项目结束时，将用于临床评估，然后进行商业化。该项目将由NeuroNexus指导，MPI Research，Inc.和密歇根大学进行临床前测试。该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所有开发、验证和验证阶段，这些阶段需要准备一份IDE提交文件，以获得FDA的许可，开始DBSA的初步临床试验。该项目的技术创新集中在使用先进的微制造电极技术来创造先进的临床DBS导联，该导联增强了以安全有效的方式向脑深部靶点提供治疗性刺激模式的能力。该项目将产生一种创新的、临床级的DBS领先产品，它将作为下一代DBS系统的一部分进行商业化，并将成为神经科学研究的创新研究产品。通过这样做，该项目将增加前沿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。