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: 10404502
• 负责人: Robert Jay Greenberg
• 金额: $ 111.23万
• 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/10404502
• 关键词: Address; Affect; Anatomy; Animals; Blinded; Blindness; Brain; Canada; Clinical; Clinical Research; Clinical Trials; Complex; Custom; Data; Development; Device Designs; Device Safety; Devices; Diabetic Retinopathy; Disease; Doctor of Medicine; Doctor of Philosophy; Electric Stimulation; Electrodes; Electronics; Ensure; Equipment; Europe; Eye; FDA approved; Funding; Glaucoma; Goals; Grant; Human; Implant; Implanted Electrodes; Individual; Knowledge; Measures; Medical; Modification; Multi-Institutional Clinical Trial; Neurosurgeon; Ocular Prosthesis; Optic Nerve; Patients; Performance; Persons; Phase; Photic Stimulation; Positioning Attribute; Privatization; Process; Prosthesis; Psychophysics; Recovery; Research; Retinal Degeneration; Retinitis Pigmentosa; Safety; Surface; System; Testing; Thalamic structure; Trauma; United States; United States National Institutes of Health; Validation; Vision; Visual Cortex; Visual Perception; Visually Impaired Persons; Work; adverse event monitoring; base; blind; density; design; experience; experimental study; human subject; implantation; in vivo; neurophysiology; neurosurgery; photoreceptor degeneration; prototype; relating to nervous system; retina implantation; retinal prosthesis; sight restoration; success; wireless

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, and most of these currently have no hope of vision recovery. Recently, a retinal prosthesis has become available in Europe, U.S., and Canada for people with profound vision loss from Retinitis Pigmentosa, a degenerative retinal disease. This prosthesis, the Argus® II Retinal Prosthesis System, has been approved by the FDA for commercial use in these patients. However, the Argus II System can only help a small subset of people who are profoundly blind. 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 will be based on the successful platform of the Argus II System, 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. This visual cortical prosthesis, called the Orion, will consist of an array of 60 electrodes that is implanted on the surface of the brain, a receiving antenna, and an electronics case. The implant will communicate wirelessly with the external equipment via a transmitting antenna. Other external components include glasses embedded with a small video camera and a video processing unit that the implanted patient wears on a belt or strap. This project will be to conduct a small early feasibility clinical trial of the device in ten people, to evaluate safety, efficacy, reliability and to conduct psychophysics characterization studies. At the end of this grant period, the cortical prosthesis will be completely developed and positioned for testing in a larger group of human subjects.

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 使人衰弱，但深度失明是毁灭性的个人的独立能力 并执行日常任务和活动。在美国有成千上万的人 国家遭受严重的失明，其中大多数目前没有希望的视力 复苏 最近，视网膜假体已经在欧洲、美国、和加拿大 患有色素性视网膜炎，这是一种退化性视网膜疾病。这 Argus® II视网膜假体系统已被FDA批准用于 在这些患者中的商业用途。然而，Argus II系统只能帮助一小部分 那些极度失明的人 本项目的目标是进行一项小规模的临床研究，目的是开发 视觉假体的最终版本将被放置在视觉皮层-大脑的一部分， 流程愿景。它将基于Argus II系统的成功平台， 被改造后植入大脑皮质假体可以帮助恢复视觉感知， 许多严重失明的人，包括因疾病而失去视力的人， 或对眼睛、视神经或丘脑造成损害。 这个视觉皮层假体，称为猎户座，将由60个电极组成的阵列， 植入大脑表面，接收天线和电子盒。植入物 将通过发射天线与外部设备进行无线通信。其他 外部组件包括嵌入有小型摄像机和视频的眼镜， 植入患者佩戴在腰带或带子上的处理单元。 该项目将在10人中进行该设备的小型早期可行性临床试验， 评价安全性、有效性、可靠性，并进行心理物理学表征研究。在 在此资助期结束时，皮质假体将完全开发和定位 用于在更大的人类受试者群体中进行测试。