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 美国的失明是一个大问题。任何重要的视力丧失是 令人衰弱但深刻的失明是毁灭个人独立的能力 并执行每天的任务和活动。曼联成千上万的人 国家遭受了深远的失明，目前大多数都没有视力的希望 恢复。 最近，在欧洲，美国和加拿大为人们提供了视网膜假体 具有视网膜炎色素炎的视力丧失，这是一种退化性残留疾病。这 假体是Argus®II视网膜假体系统，已获得FDA的批准 这些患者的商业用途。但是，Argus II系统只能帮助一小部分 深刻盲目的人。 该项目的目的是进行小型临床研究，目的是开发 视觉假体的最终版本将放在视觉皮层中 - 大脑的一部分 过程视觉。它将基于Argus II系统的成功平台，但 修改为大脑中的植入物。皮质假体可以帮助恢复视觉感知 许多更深刻的盲人，包括因疾病而失去视力的人 或对眼睛，视神经或丘脑的损害。 这种视觉皮质假体被称为猎户座，由60个电子的阵列组成 植入大脑表面，接收天线和电子情况。植入物 将通过传输天线与外部设备无线通信。其他 外部组件包括带有小型摄像机和视频的眼镜 植入患者戴在皮带或皮带上的处理单元。 该项目将是对十个人进行该设备的小型早期可行性临床试验，以 评估安全性，效率，可靠性并进行心理物理学特征研究。 在这一赠款期的结束时，皮质假体将被完全开发和定位 用于在较大的人类受试者中进行测试。