Exploration of the Effectiveness and Mechanism of Personalized Epidural Electrical Stimulation in Improving Upper Limb Function in Participants With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in neurological level of injury as determined by motor and sensory function assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).
研究概览
简要总结
This study aimed to determine whether cervical spinal cord epidural electrical stimulation (EES) can activate upper-limb muscles in individuals with spinal cord injury.
详细描述
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years.
- •Duration since spinal cord injury ranging from 1 to 10 years.
- •Spinal cord injury level at or above T
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Epidural electrical stimulation (EES) (Device)
结局指标
主要结局
Change in neurological level of injury as determined by motor and sensory function assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).
时间窗: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) is a standardized tool for assessing neurological impairment after spinal cord injury. It evaluates motor and sensory functions to determine the neurological level of injury and classify injury severity using the ASIA Impairment Scale (AIS), ranging from Grade A (complete injury) to Grade E (normal function).
Change dexterity of the upper limb as measured by the Action Research Arm Test (ARAT)
时间窗: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
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.
Change in hand dexterity as measured by the Box and Block Test (BBT).
时间窗: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
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.
Change in functional independence as measured by the Spinal Cord Independence Measure III (SCIM-III)
时间窗: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
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.
Change in ASIA Impairment Scale (AIS) grade assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).
时间窗: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
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.
次要结局
- Change in activities of daily living as measured by the Barthel Index (BI).(Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation)
- Change in spasticity as measured by the Modified Ashworth Scale (MAS)(Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation)
- Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF)(Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation)