Exploration of the Effectiveness and Mechanism of Personalized Epidural Electrical Stimulation in Improving Upper Limb Function in Participants With Spinal Cord Injury
2026年7月23日 更新者：Buddhist Tzu Chi General Hospital
This study aimed to determine whether cervical spinal cord epidural electrical stimulation (EES) can activate upper-limb muscles in individuals with spinal cord injury.
研究概览
详细说明
This study aims to determine whether epidural electrical stimulation (EES) of the cervical spinal cord can activate arm and hand muscles in patients with spinal cord injury.
Participants will undergo surgery to implant a system designed for cervical spinal cord EES.
Following surgery, they will engage in structured physical rehabilitation and electrical stimulation therapy.
Researchers will quantify the motor potentials in arm and hand muscles evoked by cervical EES, adjust stimulation parameters to optimize the elicitation of arm and hand movements, and assess the participants' upper-limb motor function using standard clinical tests and simple motor tasks.
研究类型
介入性
注册 (估计的)
20
阶段
- 不适用
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。
学习联系方式
- 姓名：Yu-Chen Chen, M.D., Ph.D.
- 电话号码：13054 +886-3-856-1825
- 邮箱：spring810569@gmail.com
研究联系人备份
- 姓名：Sheng-Tzung Tsai, M.D., Ph.D
- 电话号码：13054 +886-3-856-1825
- 邮箱：flydream.tsai@gmail.com
学习地点
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-
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Hualien City、台湾
- 招聘中
- Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
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接触：
- Sheng-Tzung Tsai, M.D., Ph.D
- 电话号码：13054 +886-3-856-1825
- 邮箱：flydream.tsai@gmail.com
-
-
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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age between 18 and 70 years.
- Duration since spinal cord injury ranging from 1 to 10 years.
- Spinal cord injury level at or above T4.
- MRI and/or CT imaging confirms adequate spinal cord decompression and spinal stability.
- Stable vital signs and no dependence on mechanical ventilation.
- Stable neurological and psychological status, with no history of neurological deterioration within the past 6 months (e.g., acute worsening of motor or sensory function, new-onset seizures, acute changes in muscle tone, or other neurological symptoms). Participants must be conscious, able to understand, and comply with study instructions. Clinical neurological examinations and imaging findings (MRI or CT) should demonstrate no new abnormalities.
- Willingness to participate in and comply with rehabilitation programs.
- Participants who have completed spinal cord electrical stimulation implantation surgery and/or are currently undergoing conventional rehabilitation therapy.
Exclusion Criteria:
- Patients with untreated fractures of the upper extremities.
- Patients with severe skin lesions or wounds that interfere with EMG electrode placement or the surgical sites for electrical stimulation implantation (e.g., chest/back, upper extremities, posterior cervical region, or subclavicular area).
- Patients with a history of other neurological diseases.
- Patients with known allergy or hypersensitivity to silver (Ag).
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
- 主要用途：治疗
- 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：Epidural electrical stimulation (EES)
Participants will undergo implantation of a 16-electrode epidural spinal cord array.
Following surgery, they will participate in a structured program of physical rehabilitation combined with epidural electrical stimulation.
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受试者将接受外科手术植入一个为颈髓提供硬膜外电刺激（EES）的系统。
手术后，受试者将接受结构化的身体康复计划和电刺激。
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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 |
|---|---|---|
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Change dexterity of the upper limb as measured by the Action Research Arm Test (ARAT)
大体时间：Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
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Use the Action Research Arm Test (ARAT) assessment to quantify functional hand and arm dexterity.
The score ranges from 0 to 57, with a higher value indicating better function.
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Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
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Change in hand dexterity as measured by the Box and Block Test (BBT).
大体时间：Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
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The Box and Block Test (BBT) assesses manual dexterity and upper extremity function by measuring the number of blocks transferred within 60 seconds.
Higher scores indicate better hand function and coordination.
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Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
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Change in functional independence as measured by the Spinal Cord Independence Measure III (SCIM-III)
大体时间：Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
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The Spinal Cord Independence Measure III (SCIM-III) is a standardized functional assessment tool specifically designed for individuals with spinal cord injury.
It evaluates independence in daily activities, including self-care, respiration and sphincter management, and mobility, to quantify the impact of spinal cord injury on functional ability.
The SCIM-III consists of 19 items, Each item is typically scored on a scale ranging from 0 (completely dependent) to 3 (completely independent).with
higher scores indicating greater independence in activities of daily living.
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Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
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Change in ASIA Impairment Scale (AIS) grade assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).
大体时间：Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
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The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) is a standardized assessment of motor and sensory function following spinal cord injury.
Neurological impairment is classified using the American Spinal Injury Association (ASIA) Impairment Scale (AIS), which ranges from Grade A (complete injury) to Grade E (normal motor and sensory function).
Higher AIS grades indicate better neurological function and less severe neurological impairment.
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Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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根据世界卫生组织生活质量 (WHOQOL-BREF) 衡量的生活质量 (QOL) 变化
大体时间：基线；植入后 1 - 4 - 7 - 13 - 19 - 25 个月
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WHOQOL-BREF 是一份自填问卷，包含 26 个问题，涉及个人在过去两周内对其健康和幸福的看法。
对问题的回答采用 1-5 的李克特量表，其中 1 代表“不同意”或“完全不同意”，5 代表“完全同意”或“非常同意”。
，得分越高，生活质量越好
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基线；植入后 1 - 4 - 7 - 13 - 19 - 25 个月
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Change in spasticity as measured by the Modified Ashworth Scale (MAS)
大体时间：Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
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Quantify spasticity scores using the Modified Ashworth Scale (MAS) for the shoulder, elbow, and wrist.
The muscle tension is divided into 0-4 grades.
The lower the score, the closer to normal.
The higher the score, the more severe the spasticity.
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Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
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Change in activities of daily living as measured by the Barthel Index (BI).
大体时间：Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
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The Barthel Index (BI) assesses functional independence in activities of daily living across 10 domains, including self-care, mobility, and continence.
Scores range from 0 to 100, with higher scores indicating greater independence.
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Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
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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。
调查人员
- 首席研究员：Sheng-Tzung Tsai, M.D., Ph.D、Hualien Tzu Chi General Hospital
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 (实际的)
2025年11月17日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2026年7月20日
首先提交符合 QC 标准的
2026年7月20日
首次发布 (实际的)
2026年7月23日
研究记录更新
最后更新发布 (实际的)
2026年7月24日
上次提交的符合 QC 标准的更新
2026年7月23日
最后验证
2025年8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.