跳至主要内容
临床试验/NCT05951556
NCT05951556招募中不适用

Individualizing Home Use of an Electroencephalographic or EEG-based Brain-computer Interface (BCI) Using Telemedicine

Shirley Ryan AbilityLab2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2021年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
7
试验地点
2
主要终点
Log of communication

研究概览

简要总结

Determine if Telehealth intervention can allow/empower a caregiver (who is untrained) to effectively implement and utilize a Brain-Computer Interface for communication with a participant who is "Locked in" following progression of Amyotrophic Lateral Sclerosis and other conditions.

详细描述

People with Amyotrophic Lateral Sclerosis (ALS) or other conditions such as a pontine stroke may develop a condition called Locked In Syndrome (LIS) where they are unable to use alternative communication strategies such as eyegaze to allow for communication for social needs or instruction to caregivers. Brain-Computer Interface (BCI) devices have been shown in the laboratory to allow participants to effectively communicate needs and engage in social communication. However, translation of this research to the home environment has been limited. In order to be a functional option for people to utilize, BCI needs to be much easier to set up and operate.

This study is designed to determine if telehealth intervention is sufficient to allow an untrained caregiver to set up and maintain a BCI for a person with a long-term communication difficulty given LIS.

Participants will receive a computer and associated hardware to allow for set up of the BCI. Videoconference support will be provided by the research team to allow the client and caregiver to set up the device in their home. Participants will hopefully be able to use the device to generate novel communication related to their care and engage in social needs with caregivers and/or family members. Communication that is generated will be logged and times that the participant is engaged in use of the BCI when not under direct support by the researchers will also be monitored.

The hypothesis is that telehealth support will be sufficient to allow for setting up the computer. If this is true, this will make it much easier for a client to engage in use of a BCI to allow for that communication versus the current need of traveling to a clinic or other specialized setting.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
16 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis leading to severe communication impairment

排除标准

  • 未提供

研究组 & 干预措施

All Participants

Experimental

All Participants will receive trial device and will be trained (via Telehealth) in its use.

干预措施: Use of BCI (Device)

结局指标

主要结局

Log of communication

时间窗: From date of enrollment in study until the date of discontinuation of the intervention, whichever came first, assessed up to 100 months

Logs of any communication will be kept by monitoring number of accurate selections while utilizing the BCI.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Colin Franz

Attending MD, Principal investigator

Shirley Ryan AbilityLab

研究点 (2)

Loading locations...

相似试验