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临床试验/NCT03900247
NCT03900247Unknown不适用

Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface

University of Aarhus1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年3月18日最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
试验地点
1
主要终点
Action Research Armtest part b Grip

研究概览

简要总结

The current project will aid patients with motor impairment to reduce the need for homecare. Specifically the aim is to develop and implement a robotic exoskeleton and brain computer interface to assist and eventually perform arm and hand movement in patients with the progressive neurodegenerative disease ALS. This proposal brings together state-of-the-art robotic technology, EEG-based brain computer interface (BCI) know-how, clinical expertise, patient perspective and industrial partners to develop and implement a robotic arm/hand device that will adapt, with increasing brain-computer control, based on the need of the patient. In short the BCI will measure electroencephalography (EEG) from the surface of the scalp and recognize signature EEG as the patient intents to move. As the patient loses muscle power the BCI robotic-device will gradually take over and support motor activity, even when the patient is totally paralyzed. As the device supports hand/arm function only, the investigators aim to address ADLs associated to hand function, specifically eating activities.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •ALS according to the latest revision of El Escorial Criteria (Ludorph et al. 2015)
  • •Loss of muscle force or fine motor skills in a hand

排除标准

  • •Other severe Neurological or Psychiatric disease
  • •Drug or Alcohol dependency
  • •Pregnancy
  • •Severe cognitive disturbances found to impede with study completion

结局指标

主要结局

Action Research Armtest part b Grip

时间窗: At 6 months

performance with and without BCI/robotic device

次要结局

  • Grip strength(At 6 months)
  • Bringing glass of water to the mouth(At 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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