Early Feasibility Clinical Trial of a Visual Cortical Prosthesis

视觉皮质假体的早期可行性临床试验

• 批准号: 10365847
• 负责人: Jessy D Dorn
• 金额: $ 15.6万
• 依托单位: SECOND SIGHT MEDICAL PRODUCTS, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-15 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10365847
• 关键词: Adopted; Adoption; Animal Testing; Benefits and Risks; Bioethics; Blindness; Brain; Clinical; Clinical Research; Clinical Trials; Cochlea; Communities; Data; Development; Device or Instrument Development; Devices; Disease; Ear; Elements; Engineering; Equilibrium; Exclusion Criteria; Exposure to; Eye; Feasibility Studies; Future; Glean; Goals; Grant; Human; Implant; Individual; Interview; Investigation; Knowledge; Ocular Prosthesis; Operative Surgical Procedures; Optic Nerve; Participant; Patients; Pattern; Population; Positioning Attribute; Process; Prosthesis; Protocols documentation; Psychophysics; Research Personnel; Research Proposals; Retina; Risk; Risk-Benefit Assessment; Safety; Scientist; Site; Structure; System; Target Populations; Techniques; Technology; Testing; Thalamic structure; United States; Vision; Visual Cortex; Visual Perception; Visually Impaired Persons; Work; base; blind; design; disability; expectation; experience; experimental study; feasibility testing; feasibility trial; first-in-human; human subject; implantable device; inclusion criteria; innovation; insight; neuroethics; neurotechnology; novel; novel therapeutics; parent grant; parent project; patient population; prototype; response; safety and feasibility; success

PROJECT SUMMARY Blindness in the United States is a large and increasing problem. Any significant vision loss is debilitating, but profound blindness is devastating to an individual’s ability to be independent and to perform everyday tasks and activities. Hundreds of thousands of people in the United States suffer from profound blindness. The goal of this project is to conduct a small scale clinical study with the intent of developing the final version of a visual prosthesis to be placed in the visual cortex – the part of the brain that processes vision. It is based on the successful platform of the Argus II System (a retinal visual prosthesis), but modified for implant in the brain. A cortical prosthesis could help restore visual perception to many more profoundly blind people, including people who have lost their vision due to disease or damage to the eyes, optic nerve, or thalamus. The parent project aims to evaluate safety, efficacy, reliability, and to conduct psychophysics characterization studies. The goal is that by the end of the grant period, the cortical prosthesis will be completely developed and positioned for testing in a larger group of human subjects. In addition to the above goals, it is increasingly evident that the success of such neurotechnology development also depends on critically understanding the relative valuation of risks and benefits from the perspective of the target population. These perspectives are increasingly recognized as recurring and critical in the development and adoption of new neurotechnologies. This supplement proposal in response to NOT-OD- 21-020 is a bioethics research proposal that aims to gain insight into perspectives of blind patients on acceptable risks, necessary benefits, and appropriate risk/benefit balance for visual cortical prostheses, with the aim of guiding the development of devices in line with the target population’s values. Without the input from the target population, we may be inappropriately determining the acceptable risk/benefit profile for visual cortical prostheses. Building on ongoing investigation of perspectives of current Orion trial participants, the work proposed here will interview 15 blind patient who would be eligible for Orion but have not yet been implanted, using semi-structured interviews. The knowledge gleaned will inform further development of the device, guide future psychophysical experiments, and promote regulatory approval of future trials of visual cortical prostheses in line with the target population’s perspectives and values, increasing the likelihood that the parent project to exert an influence and deliver a novel therapeutic technology.

项目摘要 在美国，失明是一个日益严重的问题。任何严重的视力丧失都会使人衰弱， 但深度失明会严重影响个体的独立能力和完成日常任务的能力 和活动.在美国，数十万人患有深度失明。 本项目的目标是进行一项小规模的临床研究，目的是开发最终的 视觉假体的一个版本被放置在视觉皮层-大脑的一部分，处理视觉。是 基于Argus II系统（一种视网膜视觉假体）的成功平台，但经过修改以植入 大脑皮质假体可以帮助许多深度失明的人恢复视觉感知， 包括由于眼睛、视神经或丘脑的疾病或损伤而失去视力的人。的 母项目旨在评价安全性、有效性、可靠性，并进行心理物理学表征 问题研究我们的目标是，在资助期结束时，皮质假体将完全开发出来， 用于在更大的人类受试者群体中进行测试。 除了上述目标，越来越明显的是，这种神经技术的成功 发展还取决于批判性地理解风险和利益的相对估值， 目标人群的视角。这些观点越来越被认为是在社会中反复出现和至关重要的。 开发和采用新的神经技术。这一补充建议是为了响应NOT-OD- 21-020是一项生物伦理学研究提案，旨在深入了解盲人患者的观点， 视皮质假体的可接受风险、必要受益和适当的风险/受益平衡， 目的是根据目标人群的价值观指导器械的开发。如果没有来自 对于目标人群，我们可能不适当地确定了视力可接受的风险/受益概况， 皮质假体基于对当前Orion试验参与者观点的持续调查， 这里提出的工作将采访15名盲人患者，他们有资格接受Orion治疗，但尚未接受治疗。 植入，使用半结构化访谈.所收集的知识将为进一步发展 设备，指导未来的心理物理实验，并促进监管批准未来的试验视觉 皮质假体符合目标人群的观点和价值观，增加了 母公司计划施加影响并提供新的治疗技术。