跳至主要内容
临床试验/NCT04380649
NCT04380649进行中(未招募)不适用

Brain Computer Interface Prototype Development for Assisted Alternative Communication in ALS

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2023年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
5
试验地点
2
主要终点
Quality of the impedance of each electrode

研究概览

简要总结

"Brain-computer interfaces (BCIs) are computer-based systems that acquire brain signals, analyze them, and translate them into commands that are relayed to an output device to carry out a desired action. BCIs represent a very active and promising field of research among devices for people with severe motor disabilities. As the currently available systems correspond to research prototypes, they are not adapted to daily live situations. On the other hand, some systems have recently been commercialized, principally for video games but they are not satisfactory for use as a substitute technology in disability.

A BCI's prototype for alternative communication using a virtual keyboard, the P300 Speller, has been developed by the National Institute for Research in Digital Science and Technology (Athena team - Nice University). This prototype includes an EEG-cap with gel based active electrodes. A recent study conducted on 20 patients with ALS (University Hospital, Nice) demonstrated the usability of the system and the patient satisfaction concerning the ease of use and utility. To achieve a system that can be used in daily live in severely disabled patients, technical developments are necessary.

The investigators have conceptualized and developed an ergonomic, comfortable, headset, including dry electrodes to allow a prolonged use of the system.

The purpose of the study conducted all along the development of the headset is to improve the developed system until a successful system is achieved. This study is a monocentric usability study conducted on ALS people.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Quality of the impedance of each electrode

时间窗: at 6 months

The quality will be considered satisfactory if the impedance value of each of the electrodes is ≤ 1 000 kOhm, according to literature data.

Patient/caregiver satisfaction

时间窗: at 6 months

The evaluation of patient and caregiver satisfaction will be carried out using visual analogue scales (VAS rated from 0 to 10) on their feelings (patient/caregiver) of use.

prototype set-up time

时间窗: at 6 months

The time for setting up the prototype will be defined in seconds by the time elapsed between the start and stop of the stopwatch, the installation sequence being defined as follows: * start of the stopwatch: patient seated, equipment positioned on the table * patient or caregiver (depending on the patient's motor skills; 1 person): takes the prototype and positions it on the (patient's) skull * stopwatch stop: when the prototype is set up ready to operate

Number of errors during calibration

时间窗: at 6 months

The number of errors in copying the 10 letters during the calibration phase will be counted.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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