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

基本信息

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
项目类别：
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

项目摘要

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。令人衰弱，但深刻的失明是毁灭个人独立的能力并执行日常任务和活动。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的视力丧失，这是一种退化性视网膜疾病假体是Argus®II视网膜假体系统，已获得FDA的批准但是，这些患者的商业用途。深刻盲目的人。该项目的目的是进行小规模的临床研究，目的是开发最终视觉假体愿景将基于Argus II系统的成功平台修改为大脑中的植入物。许多更深刻地盲目的盲人，使哈比因疾病失去视力的人不或对眼睛，视神经或丘脑的损害。该视觉皮质假体（称为猎户座）将由60个电极组成植入大脑的表面，接收天线和植入物将通过传输天线与外部设备通信无线设备。外部组件包括带有小型摄像机和视频的眼镜加工单元植入的患者戴在皮带或皮带上。该项目将是该设备在十个人中对该设备进行的一项小型早期可行的临床试验。评估安全性，有效性，可靠性并进行心理物理学特征研究赠款期的结束，皮质假体将被组成并定位用于在较大的人类受试者中进行测试。