Novel Brain Signal Feedback Paradigm to Enhance Motor Learning After Stroke
研究概览
详细说明
This study aims to develop and test an innovative protocol for recovery of wrist extension after stroke, using a combination of rtfMRI, rtfNIRS, FES, and motor learning.
Aim I. Test the innovative coordination training protocol of combination rtfMRI/rtfNIRS central neural feedback and peripherally-directed, neurally-triggered FES-assisted coordination practice implemented within a framework of motor learning principles.
Hypothesis 1. Chronic stroke survivors will show significant improvement in upper limb function in response to the combined rtfMRI/rtfNIRS central neural feedback; peripherally-directed FES-assisted coordination practice of wrist and finger extension; and whole arm/hand motor learning (Primary measure: Pre-/post-treatment change score in Arm Motor Abilities Test - function domain (AMAT - F); secondary measure: Pre/post-treatment change score in Fugl-Meyer upper limb coordination.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Florida
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Gainesville、Florida、美国、32608
- North Florida/South Georgia Veterans Health System, Gainesville, FL
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Cognition sufficiently intact to give valid informed consent to participate.*
- Sufficient endurance to participate in rehabilitation sessions.
- Ability to follow 2 stage commands.
- Medically Stable
- Age > 21 years.
- Impaired upper limb function as follows: impaired ability to flex and extend the wrist.
- At least 5 degrees of wrist flexion and extension of the wrist.
- Passive ROM of wrist extension of at least 20 degrees.
- At least 6 months post stroke.
Exclusion Criteria:
- Metal implants, pacemaker, claustrophobia, inability to operate the MRI patient call button or any other contraindications for MRI.
- Acute or progressive cardiac (including cardiac arrhythmias), renal, respiratory, neurological disorders or malignancy.
- Active psychiatric diagnosis or psychological condition, or active drug/alcohol abuse.
- Lower motor neuron damage or radiculopathy.
- More than one stroke.
Pregnancy (discontinued from the study, if a woman becomes pregnant). * The combined scores for the Aid to Capacity Evaluation (ACE) and Mini-Mental Status Examination (MMSE) as follows:
- MMSE 24-30 + the ACE score that states 'definitely capable'
- MMSE 17 - 23 + the ACE score that states 'probably capable'
学习计划
研究是如何设计的?
设计细节
- 主要用途:设备可行性
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Stroke Group
Intervention: Stroke subjects will receive neural feedback plus FES and motor learning intervention that spans 3 phases and up to a total of 60 sessions. Phase I: real-time fMRI neural feedback training; Phase II: rtfNIRS-based neural feedback learning (built upon self-regulation strategies learned in Phase I and also assisted by neurally-triggered, peripherally-directed FES motor practice of wrist and finger extension); Phase III: motor learning minus neural feedback for an additional sessions up to 60 total; Phase IV: follow-up testing at 3 months after-treatment ends |
We are not testing the feasibility of the imaging methods; that has been well established and is used clinically.
We are testing the feasibility of using neural feedback clinical imaging methods in a neural feedback paradigm which involves sequential rtfMRI (phase I) and rtfNIRS (phase II) training; Neurally-triggered, peripherally-directed FES-assist practice of wrist and finger extension will be combined with rtfNIRS training in Phase II; up to 60 total sessions, including additional motor learning sessions without brain neural feedback will be provided in Phase III.
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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 |
---|---|---|
Arm Motor Abilities Test Functional Domain (AMAT - F)
大体时间:change score from baseline to post-treatment; approximately 3 months.
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AMAT-F is a measure of 13 complex, coordinated tasks used in everyday living: functional normality of movement during the 13 tasks. Minimum clinically important difference (MCID) is 0.44 change score. AMAT-F : Arm Motor Abilities Test, functional domain. minimum = 0 points. maximum = 5 points. 5 points is normal function. |
change score from baseline to post-treatment; approximately 3 months.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change Score From Baseline to Post Treatment for the Fugl Meyer Coordination Scale
大体时间:from baseline to post-treatment, approximately 3 months
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FM: Fugl-Meyer Coordination Scale: arm/hand coordination of isolated joint movement. The minimum clinically important difference (MCID) is 4.25 points. FM: 0 points, no movement; 66 points, normal coordination throughout the upper limb. |
from baseline to post-treatment, approximately 3 months
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合作者和调查者
调查人员
- 首席研究员:Janis J. Daly, PhD MS、North Florida/South Georgia Veterans Health System, Gainesville, FL
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- N2192-P
- RX2192 (其他标识符:University of Florida)
计划个人参与者数据 (IPD)
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IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
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