ICVP - A Phase I Clinical Trial to Determine the Feasibility of a Human Cortical Visual Prosthesis for People With Blindness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- To test the safety of the WFMA-based cortical interface.
研究概览
简要总结
The purpose of this study is to determine the feasibility of producing artificial vision in persons with blindness. Study participants will have wireless electrical stimulators implanted into the cortical vision processing areas of their brains. The ability of the participants to perceive artificial vision in response to electrical stimulation will be assessed.
详细描述
The objective of this study is to test the safety of the ICVP system and the feasibility of eliciting visual percepts in response to electrical stimulation in persons with blindness. The electrical stimulation is provided by wireless floating microelectrode arrays (WFMAs) that are part of the ICVP system. The WFMAs are implanted in the visual cortex. Five participants will take part in the study and each participant will have multiple WFMA devices implanted in their visual cortex on one side of the brain. After recovery from surgery, participants will begin a series of tests to assess the ability of electrical stimulation to induce visual percepts and how these percepts may provide some measure of artificial vision. Weekly participant testing will occur over a period of one to three years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No light perception or bare light perception, in each eye in accordance with relevant International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes, where the physician has no expectation of improvement through currently approved treatments.
- •History of normal or near-normal vision, with or without refractive correction, during at least the first 10 years of life.
- •Adjusted to blindness for at least one year.
- •History of vision or blindness rehabilitation.
- •Willing and able to meet the time demands of the study with transportation assistance.
- •Willing to agree to audio and video recording, as specified in the pre-screening consent.
- •Motivated by altruism, willingness to participate in pioneering science.
- •Demonstrated support from spouse, family and/or friends.
- •High or average cognitive and spatial functioning.
- •Normal structural MRI.
- •English as preferred language.
- •Normal decision-making capacity.
排除标准
- •Poor adjustment to blindness, or vision loss within the last year.
- •Expectation of vision restoration to pre-blindness level through trial participation.
- •History of alcohol or drug dependence.
- •Evidence of prior immune response to an orthopedic implant which caused the implant to be explanted
- •A disease prognosis of living less than five years.
- •An implant which would prevent screening using MRI, or a pacemaker, or similar implant.
- •A history of seizures.
- •Current suicidal ideation.
- •Poor decision-making capacity.
- •Current diagnosis or history of severe mental illness.
- •Women who are pregnant or plan on becoming pregnant in the duration of the trial.
- •Hand Motion (HM) vision or better vision,
- •No Light Perception (NLP) or Light Perception (LP) vision with present OptoKinetic Nystagmus (OKN)
- •NLP vision with pupil constriction
- •Patients with Islands of perceivable vision in Goldmann Visual Field or Confrontational visual Field will also be excluded from the study.
- •Patients with Complete media opacity (complete cornea opacity, very dense cataract) that does not allow visualization of the posterior segment to determine the cause of blindness will be excluded from the study. Only patients with NLP and LP vision without OKN will be included in the study.
- •Patients with NLP or LP vision since birth will also be excluded from the study, as they may not have fully developed higher visual pathways, including cortical connections
研究组 & 干预措施
WFMA Cortical Visual Prosthesis Single-arm Study
The WFMA is an electronic device that is implanted in the cortical vision processing regions of the brain to produce artificial vision.
干预措施: WFMA - wireless floating microelectrode array (Device)
结局指标
主要结局
To test the safety of the WFMA-based cortical interface.
时间窗: From two-weeks post-op to end of device use, up to 3 years.
Safety is defined as the number of adverse events occurring over the study period due to surgical complications or use of the WFMA device.
次要结局
- To test the efficacy of the WFMA-based cortical interface(From four-weeks post-op to end of device use, up to 3 years.)