Epidural Electrical Stimulation for Motor and Sensory Function Reconstruction in Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Functional Independence Measure (FIM)
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) in motor and sensory function Reconstruction in chronic spinal cord injury (SCI) patients classified as ASIA B-D. The main questions it aims to answer are:
Does EES treatment significantly improve motor and sensory function in patients with SCI compared to baseline? Is EES a safe intervention for this patient population? Researchers will compare participants' motor function, sensory function, and quality of life assessments before EES implantation, immediately after activation of the device, and at 1, 3, and 6 months post-implantation to evaluate the longitudinal effects of EES.
Participants will:
Undergo surgical implantation of an EES device in the epidural space. Have the EES device activated and receive personalized stimulation parameter adjustments during follow-up visits.
Complete regular motor and sensory function assessments using standardized protocols.
Participate in structured rehabilitation training sessions while using the EES device.
Report any adverse events and complete quality of life questionnaires at specified follow-up intervals.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal Cord Injury, ASIA B-D;
- •Spinal cord injury level above T10;
- •Diagnosed with spinal cord injury for ≥ 8 months and ≤ 36 months;
- •WISCI II score < 13;
- •No significant improvement in motor dysfunction after rehabitation over the past 2 months.
- •An expected survival period of ≥ 12 months.
- •Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, cooperate with necessary postoperative rehabilitation training and tests, and assist in follow-up visits.
排除标准
- •Subjects with other severe organic neurological diseases, mental illnesses other than anxiety/depression.
- •Subjects with hemorrhagic diathesis or coagulation dysfunction (prothrombin time [PT] ≥ 18 seconds).
- •Subjects with a history of alcohol or drug abuse or dependence.
- •Subjects with mental retardation, cognitive dysfunction, or personality disorders.
- •Subjects with a history of electroconvulsive therapy or those requiring continuous electrotherapy.
- •Subjects with implanted cardiac pacemakers, cardioverters, or defibrillators. Expected survival period < 1 year.
研究组 & 干预措施
Epidural Electrical Stimulation (EES) + Standard Rehabilitation
Participants receive the EES intervention combined with standard rehabilitation therapy (e.g., physical therapy, occupational therapy) for 6 months.
干预措施: Epidural Electrical Stimulation (Procedure)
Epidural Electrical Stimulation (EES) + Standard Rehabilitation
Participants receive the EES intervention combined with standard rehabilitation therapy (e.g., physical therapy, occupational therapy) for 6 months.
干预措施: positron emission tomography-computed tomography (PET-CT) (Radiation)
Epidural Electrical Stimulation (EES) + Standard Rehabilitation
Participants receive the EES intervention combined with standard rehabilitation therapy (e.g., physical therapy, occupational therapy) for 6 months.
干预措施: Diffusion Tensor Imaging (DTI) (Radiation)
Epidural Electrical Stimulation (EES) + Standard Rehabilitation
Participants receive the EES intervention combined with standard rehabilitation therapy (e.g., physical therapy, occupational therapy) for 6 months.
干预措施: Standard Rehabilitation Therapy (Procedure)
Epidural Electrical Stimulation (EES) + Standard Rehabilitation
Participants receive the EES intervention combined with standard rehabilitation therapy (e.g., physical therapy, occupational therapy) for 6 months.
干预措施: Somatosensory Evoked Potentials (SEPs) (Procedure)
Epidural Electrical Stimulation (EES) + Standard Rehabilitation
Participants receive the EES intervention combined with standard rehabilitation therapy (e.g., physical therapy, occupational therapy) for 6 months.
干预措施: Motor Evoked Potentials (MEPs) (Procedure)
结局指标
主要结局
Functional Independence Measure (FIM)
时间窗: baseline, and 1, 3, 6 months after surgery
The Functional Independence Measure (FIM) is a widely used assessment tool designed to evaluate a person's functional status and level of independence in daily living activities, particularly among individuals with disabilities. FIM items are scored based on the level of assistance required to complete a task, ranging from 1 to 7 points per item. The FIM consists of 18 items across two domains: Motor domain (13 items): Includes activities such as eating, grooming, bathing, dressing, toileting, transfers (bed/chair, toilet, tub/shower), walking, and stair climbing. Cognitive domain (5 items): Covers communication (comprehension and expression) and social cognition (memory, problem-solving, and social interaction). The total score ranges from 18 to 126 points: ≤ 35 points: Severe dependence 36-89 points: Moderate dependence 90-119 points: Mild dependence 120-126 points: Functional independence
WISCI II (Walking Index for Spinal Cord Injury II)
时间窗: baseline, and 1, 3, 6 monthes after surgery
The WISCI II evaluates walking ability in spinal cord injury patients. It has 21 levels (0-20), with scores based on mobility aids, assistance needed, and walking distance. A score of 0 means no walking; 20 indicates independent walking over 500 meters without aids. It tracks recovery progress and helps tailor rehabilitation plans for locomotor function.
次要结局
- Modified Ashworth Scale(baseline, and 1, 3, 6 monthes after surgery)
- Penn(baseline, and 1, 3, 6 months after surgery)
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)(baseline, and 1, 3, 6 monthes after surgery)
- Modified Ashworth Scale(baseline, and 1, 3, 6 monthes after surgery)
- Penn(baseline, and 1, 3, 6 months after surgery)
- Hamilton Depression Rating Scale (HAMD)(baseline, and 1, 3, 6 monthes after surgery)
- Hamilton Anxiety Rating Scale (HAMA)(baseline, and 1, 3, 6 monthes after surgery)
- Visual Analog Scale (VAS)(baseline, and 1, 3, 6 monthes after surgery)
研究者
Junming Zhu
Chief Physician
Second Affiliated Hospital, School of Medicine, Zhejiang University