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临床试验/NCT00718497
NCT00718497已完成不适用

Comparing The Cyberlink Control System to the Manual Letter Board for Communication Purposes in the ALS Patient Population

Drexel University College of Medicine1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2007年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Time Taken to Complete a Sentence

研究概览

简要总结

New technologies are giving people with motor disabilities alternative communication and control channels. The investigators are interested in using the Cyberlink Control System as a hands free means to access a computer for people with Amyotrophic Lateral Sclerosis (ALS). The goal of this project is to determine whether this device is a practical and realistic means for ALS patients to communicate with only the use of facial muscle, brainwave, and eye movements.

The benefit of this study may be of substantial value to many people with severe motor impairment. Additionally, it is hoped that some of the study subjects may benefit by incorporating hands-free computer use into their daily lives.

This study is intended to evaluate the effectiveness of the cyberlink as a tool for daily communication compared to the standard manual letter board.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of definite or possible ALS by the El Escorial Criteria
  • Between ages of 18 to 89 years.
  • Scored two or less in the ALS FRS category 1 (Speech)
  • Scored two or less in the ALS FRS category 4 (Handwriting)
  • Cognitively intact with no other neurological diseases
  • No unstable medical problems

排除标准

  • Any subject not meeting the inclusion criteria
  • Patients unable to give informed consent either themselves or via a legally authorized personnel.
  • Patients diagnosed with neurological problems other than ALS (upon examination by the principal investigator)

结局指标

主要结局

Time Taken to Complete a Sentence

时间窗: 1 session

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 (1)

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