Cognitive neural prosthetics for clinical applications

临床应用的认知神经修复术

• 批准号: 8324695
• 负责人: RICHARD A ANDERSEN
• 金额: $ 39.42万
• 依托单位: CALIFORNIA INSTITUTE OF TECHNOLOGY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-02-15 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8324695
• 关键词: Accidents; Adverse event; Algorithms; Amyotrophic Lateral Sclerosis; Animals; Area; Behavioral; Biocompatible; Brain; Chronic; Clinic; Clinical Research; Clinical Trials; Clinical Trials Design; Cognitive; Collaborations; Computer Interface; Computers; Data; Data Analyses; Devices; Disabled Persons; Elements; Environment; Evaluation; Foundations; Goals; Grant; Health; Homologous Gene; Human; Implant; Individual; Infection; Institutional Review Boards; Intention; Laboratories; Learning; Limb structure; Location; Medical Device; Modeling; Monitor; Monkeys; Motor Cortex; Movement; Multiple Sclerosis; Neurons; Outcome; Paralysed; Parietal; Parietal Lobe; Patients; Performance; Peripheral Nervous System Diseases; Phase; Phase I Clinical Trials; Positioning Attribute; Preclinical Testing; Process; Public Health; Research; Robotics; Rodent Model; Safety; Series; Signal Transduction; Site; Skin; Source; Spinal Cord Lesions; Stroke; Technology; Technology Assessment; Testing; Time; United States Food and Drug Administration; Utah; Work; arm; base; biomaterial compatibility; clinical application; cognitive control; design; efficacy testing; gaze; good laboratory practice; human subject; implant material; implantation; improved; mind control; neural prosthesis; nonhuman primate; novel; performance tests; public health relevance; relating to nervous system; research study; response; virtual reality; wound

DESCRIPTION (provided by applicant): The objective of this application is to assess, in human posterior parietal cortex (PPC), the efficacy of both microwire-based array technology and decoding algorithms for neural prosthetic applications. An outcome of this work is a human-approved microwire array technology capable of reaching deep sulcal areas of the cortex. In animals, the posterior parietal cortex is an area that we have shown to encode both the reach target (goal) location and real time dynamics in point-to-point arm reaching tasks. It is our intention to show that, in the human, these features are also encoded and that goal and dynamic information can be combined for more accurate decoding of movement intentions. In addition, our research with animals has demonstrated that the PPC encodes a number of cognitive variables that could be potentially useful for neural prosthetic applications. Tasks will be designed to see if these cognitive signals can also be recorded and decoded from human PPC. These tasks will examine 1) rapid decoding of movement sequences; 2) decoding higher level aspects of goal information that are symbolic and non-spatial; 3) local field potentials to increase decode accuracy and provide a foundation for cognitive state decoding; 4) context decoding; 5) learning as a function of practice for goal and trajectory decoding and 6) learning novel effecter dynamics. We hypothesize that these cognitive aspects of animals' PPC are also available in the corresponding human PPC. Our five year goal for this grant is to complete the preclinical testing for an investigational device exemption (IDE) to the Food and Drug Administration, submit and gain approval for an IDE, obtain IRB approvals and design the behavioral tasks and data analysis that will be used in subsequent human clinical studies, and perform a clinical trial with two subjects. To this end, we have put forth five specific aims: (1) to perform a biocompatibility assessment of the technology per recommended standards, (2) to perform a histological assessment of the technology following chronic implantation, (3) to perform a safety and efficacy assessment in a non-human primate model, (4) to test the performance of decoding algorithms that will be used in humans, and (5) to assess the performance of our technology and cognitive decoding algorithms in paralyzed individuals under an FDA approved Investigational Device Exemption Clinical Trial. PUBLIC HEALTH RELEVANCE: This application has direct relevance to public health since its goal is to perform clinical trials to test a neuroprosthetic medical device for implantation in posterior parietal cortex. The clinical trials are designed to help patients with severe paralysis, which can result from spinal cord lesion and other traumatic accidents, peripheral neuropathies, amyotrophic lateral sclerosis, multiple sclerosis, and stroke.

描述（由申请人提供）：本申请的目的是在人类后顶叶皮层（PPC）中评估基于微孔的阵列技术和解码算法对神经假体应用的疗效。这项工作的结果是一种人类批准的微管阵列技术，能够到达皮质的深沟区域。在动物中，后顶叶皮层是我们证明的一个区域，可以编码触及目标（目标）位置和实时动态，以插入点对点臂达到任务。我们的目的是表明，在人类中，这些特征也是编码的，并且可以将目标和动态信息组合起来，以更准确地解码运动意图。 此外，我们对动物的研究表明，PPC编码了许多可能对神经假体应用可能有用的认知变量。将设计任务以查看这些认知信号是否也可以从人类PPC记录和解码。这些任务将检查1）运动序列的快速解码； 2）解码符号和非空间的目标信息的更高级别； 3）局部现场潜力提高解码的准确性并为认知状态解码提供基础； 4）上下文解码； 5）学习作为目标和轨迹解码的实践的函数以及6）学习新颖的效应器动力学。我们假设动物PPC的这些认知方面在相应的人类PPC中也可用。 我们这项赠款的五年目标是完成对食品药品监督管理局的研究设备豁免（IDE）的临床前测试，提交和获得IDE的批准，获得IRB批准并设计将在后续人类临床研究中使用的行为任务和数据分析，并对两名受试者进行临床试验。为此，我们提出了五个具体目的：（1）对根据建议的标准进行技术评估，（2）对慢性植入后对技术进行组织学评估，（3）在非人类的Primate模型中执行安全性和有效性评估，（4）可以评估Algorithmans and and and and and and ton Humans和humans（4）的性能（4）根据FDA批准的研究装置豁免临床试验，在瘫痪的个体中解码算法。 公共卫生相关性：此应用与公共卫生有关，因为其目标是进行临床试验，以测试神经假体的医疗装置，以植入后顶叶皮层中。该临床试验旨在帮助患有严重麻痹的患者，这可能是由脊髓病变和其他创伤性事故，周围神经病，肌萎缩性侧面硬化症，多发性硬化症和中风引起的。