Epidural Electrical Stimulation for Spinal Cord Injury Patients and Corticospinal Motor Circuit Improvement
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
- 2
- 主要终点
- Electromyographic analysis
研究概览
简要总结
The study aims to examine the plausible interventional mechanisms underlying the effects of epidural spinal cord stimulation.
详细描述
The purpose of this study is for the treatment of spinal cord injury (SCI) paralysis patients use the signal by electrophysiological analysis of epidural spinal cord stimulation (SCS) settings that promote limbs activity so that SCI patients can restore motor ability under multiple sensory stimuli and multimodal electrical stimulation rehabilitation. The investigators hope to establish an atresia nerve regulation strategy and observe that the original blocked neural circuits can improve nerve plasticity by SCS. Even can establish new connections through residual nerves and allow SCI patients to rebuild neural circuits without SCS to restore limbs mobility and improve quality of life.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCI ASIA: A, B, C,D
- •Between 20 and 70 year of age
- •>1 year post SCI
- •Complete or incomplete spinal cord injury.
- •Expected will undergo spinal cord stimulation surgery.
- •Continued rehabilitation after surgery for spinal cord injury.
- •Able to comply with procedures and follow up.
- •Stable medical condition without cardiopulmonary disease or dysautonomia that would - contraindicate participation in lower extremity rehabilitation or testing activities
排除标准
- •Have significant cognitive impairment (MMSE<24).
- •Had a mental illness within one year or been treated in the past.
- •Have Major depressive disorder.
- •Active cancer diagnosis.
- •Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training.
- •Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention.
- •Unable to read and/or comprehend the consent form.
- •Have concerns about this trial and do not sign consent.
研究组 & 干预措施
Epidural Stimulator
Participants will have a 16-electrode epidural array implanted in the C4-C7 and T11-L2 areas of the spinal cord. Following a 2 weeks recovery period, patients will engage in a structured training of physical rehabilitation and electrical stimulation.
干预措施: Epidural Stimulator (Device)
结局指标
主要结局
Electromyographic analysis
时间窗: To measure assessing change between pre-implant and every 3 months until 24 months.
Average of 5-repetitive EMG activity for each superficial component of muscles from a five-second ramp contraction to the end of a ten-second rest
Electroencephalography and Electromyography
时间窗: To measure assessing change between pre-implant and every 3 months until 24 months.
To measure activity in the brain
Single transcranial magnetic stimulation
时间窗: To measure assessing change between pre-implant and every 3 months until 24 months.
To evaluate the function of corticospinal tract nerve conduction
Motion Analysis
时间窗: To measure assessing change between pre-implant and every 3 months until 24 months.
To evaluate the angles that can be achieved at each joint of the upper limbs
Functional Test
时间窗: To measure assessing change between pre-implant and every 3 months until 24 months.
To evaluate gait for subjects who can walk by assistive device or independently
次要结局
- American Spinal Injury Association (ASIA-2019) Impairment Scale(To measure assessing change between pre-implant and every 3 months until 24 months.)
- Modified Ashworth scale(To measure assessing change between pre-implant and every 3 months until 24 months.)
- Barthel Index(To measure assessing change between pre-implant and every 3 months until 24 months.)
- Spinal Cord Independence Measure(To measure assessing change between pre-implant and every 3 months until 24 months.)
- World Health Organization Quality of Life Brief Version(To measure assessing change between pre-implant and every 3 months until 24 months.)
- Box and Block Test(To measure assessing change between pre-implant and every 3 months until 24 months.)
- Action Research Arm Test Scoring Sheet(To measure assessing change between pre-implant and every 3 months until 24 months.)
- Walking Index for Spinal Cord Injury II (WISCI II- March 2005)(To measure assessing change between pre-implant and every 3 months until 24 months.)
- Berg Balance Scale(To measure assessing change between pre-implant and every 3 months until 24 months.)