跳至主要内容
临床试验/NCT01119001
NCT01119001已完成不适用

A P300 Brain Computer Interface Keyboard to Control Assistive Technology for People With Amyotrophic Lateral Sclerosis

University of Michigan2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2010年2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
13
试验地点
2
主要终点
Accuracy of Typing With a BCI Keyboard by ALS Patients.

研究概览

简要总结

People with Amyotrophic Lateral Sclerosis (ALS) will use a P300 based brain computer interface (BCI) keyboard to type in assistive technology devices. The results of this study will be compared with a previous study of a P300 BCI keyboard used by healthy volunteers.

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

入选标准

  • Age 18 or older.
  • Diagnosed with cerebral palsy, spinal cord injury, neuromuscular disease, or ALS that results in impaired hand and arm function making it difficult to manipulate objects (if at all) and requires help to prepare or modify activities
  • Able to see the BCI display
  • Able to give informed consent
  • Able to understand and remember instructions concerning participation
  • Able to communicate effectively at least with familiar conversation partners

排除标准

  • Are unable to give informed consent.
  • Are currently experiencing open head sores
  • Have a history of photo-sensitive epilepsy
  • Have a history of cognitive deficits requiring accommodation or special education services
  • Are unable to sit without moving the head and neck for at least 15 minutes

结局指标

主要结局

Accuracy of Typing With a BCI Keyboard by ALS Patients.

时间窗: 3 times over 2-4 weeks

Accuracy for the sentence typed in each environment was calculated as the percentage of characters for which the result character matched the target character. The target characters were determined based on the next character needed to complete the sentence to be copied. In the case of errors, the next character was therefore a backspace to correct the error. The target characters were modified by subject comments to account for errors in selecting the next character. Once sentence was typed in each environment in each session on a separate day. From the three repeated sessions, there were therefore 9 total sentences per subject with 3 measures for each environment. These were treated as repeated measures for the analysis.

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

Jane Huggins, PhD

Research Assistant Professor

University of Michigan

研究点 (2)

Loading locations...

相似试验