Cognixion ALS BCI Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- System Usability Score
研究概览
简要总结
The goal of this study is refine the usability of a BCI based communication platform.
The study will take place in the greater Los Angeles area and will enroll up to 10 participants with late stage ALS. Each subject will receive a Cognixion Axon-R augmented reality brain computer interface and associated communication software. The study duration is 3 months for each participant.
The key questions that will be addressed in this study are:
- How quickly can participants learn and gain confidence with a pure BCI interface.
- How effective are alternate input modalities including eye tracking for this use case.
- Identify the extent to which generative AI based personalization impacts the communication quality.
Key measures include:
ITR - information transfer rate SUS - system usability scale
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have someone (LAR) who can consent to their participation and who will be present in the study alongside the participant
- •Must have a designated individual who can be trained on the Cognixion system
- •Fluent in understanding English
- •18 years or older
- •Must have ALS and need an assistive communication device
- •Must be able to engage in volitional eye opening and sustain eye opening independently for x duration
- •Must have a way to communicate apart from using the Cognixion device such as vocalizations, head nod, eye blinks, eyebrow raises, etc. At a minimum, reliable way of communicating "Yes" and "No"
排除标准
- •Disruption in English comprehension, either due to lack of fluent proficiency or due to a developmental/acquired language disorder (e.g. aphasia)
- •Severely hearing impaired or deaf
- •Sensitivity to flashing lights
- •History of epilepsy and/or seizures
- •Vision disorders restricting the visual field such as glaucoma, diplopia (double vision), nystagmus (involuntary eye movements)
- •History of vertigo or other vestibular disorders
- •Scalp that is prone to irritation, inflammation, injury, or infectious process
结局指标
主要结局
System Usability Score
时间窗: 3 months from training and setup of device.
A score ranging from 0 to 100 that captures the usability the device. This is an essential characteristic of a device feasibility study.
Information Transfer Rate (ITR)
时间窗: 3 months from training and setup of device.
The rate, in bits per minute, of information transfer for each of the device modalities. ITR is measured using a standardized selection procedure.
次要结局
- Words per Minute (WPM)(3 months from training and setup of device.)