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临床试验/NCT02552368
NCT02552368已完成不适用

A Brain Computer Interface and Brain-Controlled Stroke Rehabilitation Method Utilizing Electroencephalography in Hemiparetic and Hemiplegic Stroke Patients to Achieve Thought Control of Machines and a Better Understanding of Brain Function

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2012年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Change in Action Research Arm Test (ARAT) Score

研究概览

简要总结

The ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor-impaired stroke survivors. This ultimate goal will be approached through two different means. The first method is to develop a functioning brain-computer interface that operates based on cortical activity ipsilateral to an intended movement on the motor-impaired side of the body. And secondly, to develop new methods of rehabilitation that involve stimulating peripheral muscles based upon cortical activity ipsilateral to intended movements. Finally, the study seeks to assess changes in functional connectivity as a result of using a BCI device.

详细描述

This study will be carried out in two phases designed to achieve the objectives described above. The first phase will determine the feasibility of recording ipsilateral (contralesional) motor commands and use the signals to control a computer. This phase will involve recording EEG signals during the performance of real and imagined motor movements of both the impaired and non-impaired hand in stroke survivors. After recording the signals and analyzing the data, the signals will be used to try to control a cursor on a computer screen or a robotic hand. The second phase of the study will determine if the BCI system can be used to impact rehabilitation. Motor commands would be performed as in phase 1 to determine the accompanying EEG signals. The EEG signals would then be used to control stimulation of the impaired limb. Rehabilitation would be assessed by examining changes in commonly used functional motor scores.

The ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor-impaired stroke survivors. This ultimate goal will be approached through two different means. The first method is to develop a functioning brain-computer interface that operates based on cortical activity ipsilateral to an intended movement on the motor-impaired side of the body. And secondly, to develop new methods of rehabilitation that involve stimulating peripheral muscles based upon cortical activity ipsilateral to intended movements. Finally, the study seeks to assess changes in functional connectivity as a result of using a BCI device.

研究设计

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

入排标准

年龄范围
18 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 6 months post stroke
  • Modified Ashworth Scale of 1+ or less of elbow flexion in the affected upper extremity
  • Short Blessed Test Score of 8 or less
  • Unstructured Mesulam with 2 or less omissions

排除标准

  • Severe spasticity in affected upper extremity
  • Unilateral Visual Inattention (neglect)
  • Contracture(s) in the affected upper extremity
  • Botox injections administered within 9 months
  • Aphasia which limits effective communication

研究组 & 干预措施

IpsiHand

Experimental

IpsiHand is a device which includes a robotic glove that you wear on your hand and a headset that you wear on your head. The headset picks up your thoughts and sends them to the robotic glove, to control opening and closing of your hand.

干预措施: IpsiHand Device (Device)

结局指标

主要结局

Change in Action Research Arm Test (ARAT) Score

时间窗: Baseline and 12 weeks

The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia (Lyle, 1981). It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation (Platz, Pinkowski, Kim, di Bella, \& Johnson, 2005). The ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty 1) Performs test partially 0) Can perform no part of test The maximum score achievable on this measure is 57 points.

次要结局

  • Canadian Occupational Performance Measure (COPM)(Baseline and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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