Experimental and Clinical Studies of Retinal Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in shape perception
研究概览
简要总结
The study will evaluate new methods of retinal stimulation and training with the goal of improving the visual ability of retinal prosthesis participants.
详细描述
The study will test new ways to make the retinal prosthesis visual perception easier with auditory-visual training and how to make the retinal prosthesis work better at perceiving shapes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be implanted with an Argus II Retinal Prosthesis system.
- •Have 5 or more electrodes that create a perception with stimulation.
- •Must be willing and able to comply with the protocol testing requirements.
排除标准
- •Subjects participating in another investigatory drug or device study
- •Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols.
研究组 & 干预措施
Retinal stimulation
Alternative stimulus patterns will be tested (vs. baseline). The intervention is the alternative stimulus pattern. The intervention will be tested only in the clinic vs. baseline. The subject will go home with baseline settings. The two alternative stimulus patterns to be tested are asymmetric waveforms and bipolar stimulus.
干预措施: New visual processing unit (VPU) with asymmetric waveforms (Device)
Retinal stimulation
Alternative stimulus patterns will be tested (vs. baseline). The intervention is the alternative stimulus pattern. The intervention will be tested only in the clinic vs. baseline. The subject will go home with baseline settings. The two alternative stimulus patterns to be tested are asymmetric waveforms and bipolar stimulus.
干预措施: New VPU with bipolar stimulation (Device)
结局指标
主要结局
Change in shape perception
时间窗: Baseline, 8 hours
As measured by elongation ratio. The elongation ratio is the ratio of major axis length to minor axis length of an ellipse. Subjects will draw shapes on a touch screen and these shapes will be fit to an ellipse.
Percent change in stimulus thresholds
时间窗: Baseline, 8 hours
Compare baseline threshold with threshold of modified stimulus parameters. Threshold is measured in microCoulumbs ( the product of stimulus duration and stimulus amplitude).
次要结局
未报告次要终点
研究者
James Weiland
Professor of Biomedical Engineering
University of Michigan