Spinal Cord Stimulation for Spinal Cord Injury Patients - Regain Walk and Alleviate Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Assessment of volitional movement of lower limbs using 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 lower limb activity so that SCI patients can restore the ability to stand and walk 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 lower limb 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
Subjects will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord. After 2 weeks recovery,patients will undergo a structured program of physical rehabilitation and electrical stimulation.
干预措施: Epidural Stimulator (Device)
结局指标
主要结局
Assessment of volitional movement of lower limbs using electromyographic analysis
时间窗: To measure assessing change between pre-implant and every 3 months until 24 months.
Average of 6-repetitive EMG activity for each superficial component of muscles from a five-second ramp contraction to the end of a ten-second rest
6-Meter Time Up and Go (6TUG)
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.
Trunk stability measurement (trunk control assessment)
时间窗: To measure assessing change between pre-implant and every 3 months until 24 months.]
To assess the sitting and walking dynamic balance by displacing the center of pressure (CoP) from the force plate and the trunk accelerations with a tri-axial accelerometer. The experiment includes sitting and walking.pressure (CoP) from the force plate and the trunk accelerations with tri-axial accelerometer.
次要结局
- 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 motor recovery as measured by the Total American Spinal Injury Association (ASIA) motor score(Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after 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)
- Change in ability (or inability) to safely balance as measured by the Berg Balance Scale (BBS)(Baseline; 7 months after implant)