Deep Brain Stimulation Array for Neuromodulation

描述（由申请人提供）：慢性脑深部电刺激（DBS）是在过去十年中出现的一种治疗神经和精神疾病的革命性新方法。DBS目前被批准用于治疗帕金森病（PD）和原发性震颤，并有望用于治疗肌张力障碍、难治性癫痫、重度抑郁症和强迫症。DBS治疗涉及通过具有四个相对较大电极的导线进行可控电刺激，这些电极植入丘脑或基底神经节的目标区域。虽然DBS治疗通常安全有效地减少批准疾病的主要症状，但它通常具有显著的行为和认知副作用以及性能限制。此外，实验和计算研究揭示了特定疾病状态的复杂作用机制。越来越多的临床和科学证据强烈表明，精细电极定位、选择性和精确刺激模式等细节对临床结局非常重要。申报的脑深部电刺激阵列（或DBSA）是一种设计用于长期刺激的电极阵列，由许多微电极部位组成，因此可显著增强刺激选择性、精度和可调性。该器械的技术创新在于使用了大量较小的部位（64个部位），这些部位可以单独使用，也可以选择成组使用，以实现更多样化的电刺激模式。这一系列位点将显着扩大设备的可调范围，以便更好地为患者提供DBS治疗。它还将提供通过神经记录（32个部位）整合反馈控制的能力，用于最终按需DBS，类似于现代心脏起搏器。SBIR第一阶段提案的具体目标是开发DBSA的原型版本，并评估其用于选择性和可调DBS治疗的可行性。原型DBSA将用于评价器械的关键包装、材料和功能属性。第一个具体目标是开发原型DBSA，该目标的预期成果是经过验证的第一代原型设备。第二个具体目标是评估DBSA的电刺激特性。这一目标的预期结果将是DBSA的刺激能力的分析和实验分析。第三个具体目标是评价对DBSA的慢性组织反应。该目标的预期结果是所选材料、几何规格和刺激方案的安全性和生物相容性的初步数据。NeuroNexus正在与FHC，密歇根大学和克利夫兰诊所的顾问合作领导这个项目。多学科项目团队拥有经验，技能和资源来实现项目目标，并在此过程中推动神经工程领域向前发展。该项目的主要目标是开发用于脑深部电刺激（DBS）治疗的先进电极技术。DBS是用于治疗帕金森病和潜在的其他运动相关疾病的常见治疗方法。

DESCRIPTION (provided by applicant): Chronic Deep Brain Stimulation (DBS) emerged in the last decade as a revolutionary new approach to the treatment of neurological and psychiatric disorders. DBS is currently approved for treatment of Parkinson's Disease (PD) and Essential Tremor and is showing promise for treatment of dystonia, intractable epilepsy, major depression, and obsessive-compulsive disorder. DBS therapy involves controllable electrical stimulation through a lead having four relatively large electrodes that implanted in the targeted region of the thalamus or basal ganglia. While DBS therapy is generally safe and effective for reducing cardinal symptoms of the approved diseases, it often has significant behavioral and cognitive side effects and limits on performance. Additionally, experimental and computational studies have revealed complex mechanisms of action for specific disease states. The growing body of clinical and scientific evidence strongly suggests that details such as fine electrode positioning, selectivity, and precise stimulation patterning are very important for clinical outcomes. The proposed Deep Brain Stimulating Array (or DBSA) is an electrode array designed for long-term stimulation and is comprised of many microelectrode sites, therefore providing significantly enhanced stimulation selectivity, precision, and tunability. The technical innovation of this device is the use of a large number of smaller sites (64 sites) that can be used individually or in selectable groups in order to achieve more diverse electrical stimulation patterns. This array of sites will significantly expand the tunable range of the device in order to better fit the DBS therapy to the patient. It will also provide the capability of incorporating feedback control through neural recordings (32 sites) for eventual on-demand DBS, similar to that of modern cardiac pacemakers. The specific goals of this SBIR Phase I proposal are to develop a prototype version of the DBSA and to evaluate its feasibility for selective and tunable DBS therapy. The prototype DBSA will be used to evaluate critical packaging, materials, and functional attributes of the device. The first specific aim is to develop a prototype DBSA, with the expected outcome of this aim being a validated first generation prototype device. The second specific aim is to evaluate the electrical stimulation characteristics of the DBSA. The expected outcome of this aim will be an analytical and experimental analysis of the stimulation capabilities of the DBSA. The third specific aim is to evaluate the chronic tissue reactions to the DBSA. The expected outcomes of this aim are preliminary data on the safety and biocompatibility of the chosen materials, geometrical specifications and stimulation protocols. NeuroNexus is leading this project in collaboration with FHC, the University of Michigan and consultants from the Cleveland Clinic. The multi-disciplinary project team possesses the experience, skill sets, and resources to meet the project goals and, in the process, to move the field of neural engineering ahead. The primary objective of this project is the development of an advanced electrode technology used for deep brain stimulation (DBS) therapy. DBS is a common therapeutic approach for the treatment of Parkinson's Disease, and potentially other movement related disorders.