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: 10665808
• 负责人: Robert Jay Greenberg
• 金额: $ 103.28万
• 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 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10665808
• 关键词: Address; Affect; Anatomy; Animals; Blinded; Blindness; Brain; Canada; Clinical; Clinical Research; Clinical Trials; Complex; 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; Glass; Glaucoma; Goals; Grant; Human; Implant; 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; blind; density; design; experience; experimental study; human subject; implantation; in vivo; neural; neural implant; neurophysiology; neurosurgery; photoreceptor degeneration; prototype; retina implantation; retinal prosthesis; sight restoration; success; transmission process; trial planning; wireless communication

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.

项目概要 在美国，失明是一个严重且日益严重的问题。任何严重的视力丧失都是 严重的失明会让人衰弱，但对个人的独立能力来说是毁灭性的 并执行日常任务和活动。美国有数十万人 各国都遭受着严重的失明，其中大多数国家目前没有希望看到光明 恢复。 最近，视网膜假体已在欧洲、美国和加拿大可供人们使用 患有色素性视网膜炎（一种退行性视网膜疾病）导致视力严重丧失。这 Argus® II 视网膜假体系统已获得 FDA 批准用于 这些患者的商业用途。然而，Argus II 系统只能帮助一小部分人 完全失明的人。 该项目的目标是进行小规模临床研究，旨在开发 视觉假体的最终版本将被放置在视觉皮层中——大脑的一部分 处理视觉。它将基于 Argus II 系统的成功平台，但是 改良后可植入大脑。皮质假体可以帮助恢复视觉感知 许多严重失明的人，包括因疾病丧失视力的人 或眼睛、视神经或丘脑受损。 这种视觉皮层假体称为 Orion，由 60 个电极组成的阵列组成， 植入大脑表面、接收天线和电子设备外壳。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 人中对该装置进行小型早期可行性临床试验，以 评估安全性、有效性、可靠性并进行心理物理学特征研究。在 在此资助期结束时，皮质假体将完全开发并定位 用于在更大的人类受试者群体中进行测试。

项目成果

Sequence of visual cortex stimulation affects phosphene brightness in blind subjects.

视觉皮层刺激的顺序会影响盲人受试者的光幻视亮度。

• DOI: 10.1016/j.brs.2022.03.008
• 发表时间: 2022
• 期刊: Brain stimulation
• 影响因子: 7.7
• 作者: ArmentaSalas,Michelle;Bell,Joseph;Niketeghad,Soroush;Oswalt,Denise;Bosking,William;Patel,Uday;Dorn,JessyD;Yoshor,Daniel;Greenberg,Robert;Bari,Ausaf;Pouratian,Nader
• 通讯作者: Pouratian,Nader