Early Feasibility Clinical Trial of a Visual Cortical Prosthesis

项目总结

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. 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 is based on the successful platform of the Argus II System (a retinal visual prosthesis), 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. The parent project aims to evaluate safety, efficacy, reliability, and to conduct psychophysics characterization studies. The goal is that by the end of the grant period, the cortical prosthesis will be completely developed and positioned for testing in a larger group of human subjects. In addition to the above goals, it is increasingly evident that the success of such neurotechnology development also depends on critically understanding the relative valuation of risks and benefits from the perspective of the target population. These perspectives are increasingly recognized as recurring and critical in the development and adoption of new neurotechnologies. This supplement proposal in response to NOT-OD- 21-020 is a bioethics research proposal that aims to gain insight into perspectives of blind patients on acceptable risks, necessary benefits, and appropriate risk/benefit balance for visual cortical prostheses, with the aim of guiding the development of devices in line with the target population’s values. Without the input from the target population, we may be inappropriately determining the acceptable risk/benefit profile for visual cortical prostheses. Building on ongoing investigation of perspectives of current Orion trial participants, the work proposed here will interview 15 blind patient who would be eligible for Orion but have not yet been implanted, using semi-structured interviews. The knowledge gleaned will inform further development of the device, guide future psychophysical experiments, and promote regulatory approval of future trials of visual cortical prostheses in line with the target population’s perspectives and values, increasing the likelihood that the parent project to exert an influence and deliver a novel therapeutic technology.