NCT02891629已完成不适用
Safety and Feasibility of the EyeControl Device (Eye-based Communication Device) for ALS Patients
Eyefree Assisting Communication Ltd0 个研究点目标入组 15 人开始时间: 2016年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 主要终点
- Feasibility - Successful Performance Rate of Device Features
研究概览
简要总结
The EyeControl device is an eye movement-based communication device in the form of wearable glasses with connected infrared cam-era that tracks the pupil and translates blinks and movements into commands.This study is aimed to demonstrate the safety and feasibility of the EyeControl device in healthy volunteers, and ALS patients in early stages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects 18 to 65 years old
- •Subject with understandable speaking communication
- •Subject fluent in Hebrew (speech and writing skills)
- •Additional inclusion criteria for Stage 2 of the study:
- •Subjects with early stage ALS diagnosis - whose speech capability is unaffected
排除标准
- •Subjects with glasses or contact lenses
- •Subjects with eye conditions such as Ptosis, Strabismus And Crossed Eyes
- •Medical history of epilepsy
- •Subjects who according to investigator's judgement, unable to comply with the requirements of this protocol
- •Pregnant or lactating women
结局指标
主要结局
Feasibility - Successful Performance Rate of Device Features
时间窗: 2 weeks
Ability to successfully perform at least 70% of device features (controlling the application and Free text features)
次要结局
- Safety Assessment - Number of Device Related Adverse Events(2 weeks)
研究者
相似试验
已完成
不适用
Eye-Control Trial: Wearable Eye-Tracking Device as Means of CommunicationAcute Respiratory Failure Requiring Mechanical VentilationNCT04582149Emory University30
已完成
不适用
Eyelid Movement Sensor Device- Blinking CharacterizingEyelid Movement DisordersNCT02309814HaEmek Medical Center, Israel80
已完成
不适用
Safeness and usefulness of Smart Eye CameraDry Eye Disease Allergic conjunctival disease Cataract Glaucoma Age related macular degeneration etcJPRN-jRCTs032190001Shimmura Shigeto40
已完成
不适用
Eyecontrol coMmunication Platform for dEliRium manaGemEnt in Intensive Care Units (EMERGE)Delirium in Old AgeCritical IllnessIntensive Care Unit DeliriumDeliriumNCT06029244Beth Israel Deaconess Medical Center160
已完成
不适用
Smart Autofocusing EyeglassesPresbyopiaNCT03911596University of Utah17