Early Feasibility Clinical Trial of a Visual Cortical Prosthesis

项目摘要 在美国，失明是一个巨大且日益严重的问题。任何严重的视力损失都是 令人虚弱，但深度失明对个人独立的能力是毁灭性的 并执行日常任务和活动。美国有数十万人 各州患有严重失明，其中大多数目前看不到希望 恢复。 最近，一种视网膜假体已经在欧洲、美国和加拿大上市 患有视网膜色素变性疾病的视网膜色素变性导致严重视力丧失。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 严重失明的人。 这个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被放置在视觉皮质-大脑的这一部分 处理视觉。它将基于Argus II系统的成功平台，但 为植入大脑而改装的。皮质假体可以帮助恢复视觉感知 更多的深度失明的人，包括因疾病而失明的人 或眼睛、视神经或丘脑受损。 这种名为猎户座的视觉皮质假体将由60个电极组成的阵列，这是 植入大脑表面，一个接收天线，和一个电子盒。植入物 将通过发射天线与外部设备进行无线通信。其他 外部组件包括嵌入小型摄像机和视频的眼镜 植入患者佩戴在腰带或皮带上的处理单元。 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，以 评估安全性、有效性、可靠性，并进行心理物理表征研究。在… 在此授权期结束时，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。

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.