A Closed-loop Brain-computer Interface for Stroke
2020年7月7日 更新者：Taipei Veterans General Hospital, Taiwan
A Closed-loop Brain-computer Interface for Paretic Hand Stimulation After Stroke
It may be hard to acquire stable sensorimotor rhythm from the affected motor cortex for patient without a response of paretic hand.
A few studies suggest two ways to approaching closed-loop therapy: peripherally extracting the residual signals, for example electromyogram (EMG) at proximal muscles (deltoids) and centrally extracting the activity patterns from unaffected hemisphere during attempting to move paretic hand.
Therefore, understanding neural signatures of residual upper extremity movement among stroke patients might help in discovering potential therapeutic target and developing tailored brain-computer interface (BCI) therapy.
Additionally, 59.4% of stroke patients in acute stage impair at least one somatosensory modality.
It remains unclear whether the patient with somatosensory impairment hinder BCI effect.
研究概览
地位
未知
条件
详细说明
Investigators will consecutively enroll subacute (1-4 weeks after stroke onset) patients with first-time, unilateral, subcortical stroke and age-matched healthy controls.
All participants will carry on 2 sequential experiments.
In the first experiment, participants will perform 2 motor tasks using either paretic/nondominant upper extremity or non-paretic/dominant upper extremity, called motor attempt (M) condition or calibration condition.
The second experiment contains 3 conditions: cyclic functional electrical stimulation (cFES), cFES during motor attempt (M-cFES), and functional electrical stimulation during brain-computer interface (BCI-FES) in random order.
The sensorimotor oscillations from the electroencephalography (EEG), upper extremity sensorimotor function score (Fugl-Meyer test, Action Research Arm test, and Revised Nottingham Sensation Assessment), corticospinal excitability from the transcranial magnetic stimulation (TMS), and resting-state functional and structural neuroimage from magnetic resonance imaging (MRI) will be assessed before and after the final experiment, as well as 3 months after stroke.
研究类型
观察性的
注册 (预期的)
70
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Taipei city、台湾、112
- 招聘中
- Taipei Veterans General Hospital
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接触：
- i-hui Lee, MD, PhD
- 电话号码：8109 886-2-28712121
- 邮箱：ihui_lee@hotmail.com
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首席研究员：
- i-hui Lee, MD, PhD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 80年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
概率样本
研究人群
Hospitalized participants and healthy controls will be recruited from the Taipei Veterans General Hospital.
描述
Inclusion Criteria:
- first-ever, unilateral infarction or hemorrhage at middle cerebral artery or posterior cerebral artery territory
- early subacute phase of stroke (between 1 and 4 weeks after stroke onset)
Exclusion Criteria:
- electroencephagraphy feature is not usable
- Fugl-Meyer Assessment of Upper Extremity score is over 50
- ataxia
- global aphasia
- concomitant neurological diseases
- psychiatric diseases
- participating in other interventional research during this period
- other conditions might interfere with experiment
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sensorimotor rhythms
大体时间：Baseline, during experimental procedures
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electroencephalography
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Baseline, during experimental procedures
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fugl-Meyer Assessment
大体时间：At baseline (1-4 week of stroke) and at 3 months after stroke
|
Fugl-Meyer Assessment (FMA) measures both upper-limb and lower-limb motor function.
The total score of FMA ranges from 0 to 100, which higher score indicates better motor recovery.
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At baseline (1-4 week of stroke) and at 3 months after stroke
|
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Action Research Arm test
大体时间：At baseline (1-4 week of stroke) and at 3 months after stroke
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Action Research Arm test (ARAT) measures specific upper-limb and hand function.
The total score of ARAT ranges from 0 to 57, which higher score indicates better motor function.
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At baseline (1-4 week of stroke) and at 3 months after stroke
|
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Revised Nottingham Sensation Assessment
大体时间：At baseline (1-4 week of stroke) and at 3 months after stroke
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Revised Nottingham Sensation Assessment (rNSA) measures various upper-limb sensory function.
The total score of rNSA ranges from 0 to 151, which higher score indicates better somatosensory function.
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At baseline (1-4 week of stroke) and at 3 months after stroke
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Motor Activity Log
大体时间：At baseline (1-4 week of stroke) and at 3 months after stroke
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Motor Activity Log (MAL) measures real-use of upper-limb.
The averaged index of MAL ranges from 0 to 5, which higher index indicates more frequently use of paretic upper limb.
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At baseline (1-4 week of stroke) and at 3 months after stroke
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Resting motor threshold
大体时间：At baseline (1-4 week of stroke) and at 3 months after stroke
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Transcranial magnetic stimulation test
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At baseline (1-4 week of stroke) and at 3 months after stroke
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Motor evoked potential
大体时间：At baseline (1-4 week of stroke) and at 3 months after stroke
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Transcranial magnetic stimulation test
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At baseline (1-4 week of stroke) and at 3 months after stroke
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Resting-state brain connectivity
大体时间：At baseline (1-4 week of stroke) and at 3 months after stroke
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Magnetic resonance imaging
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At baseline (1-4 week of stroke) and at 3 months after stroke
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2020年7月13日
初级完成 (预期的)
2022年8月31日
研究完成 (预期的)
2022年8月31日
研究注册日期
首次提交
2020年4月20日
首先提交符合 QC 标准的
2020年7月7日
首次发布 (实际的)
2020年7月10日
研究记录更新
最后更新发布 (实际的)
2020年7月10日
上次提交的符合 QC 标准的更新
2020年7月7日
最后验证
2020年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.