Characterization of Transcutaneous and Epidural Spinal Stimulation for Enabling Motor Function in Humans With Motor Complete Paraplegia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Kinematics
研究概览
简要总结
The purpose of this study is to compare transcutaneous electrical spinal stimulation (TESS) and epidural electrical stimulation (EES); in particular, the motor activity enabled by each method and the potential health benefits of each method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Kinematics
时间窗: Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13
Change in measurements of joint angles using video-based, inertial measurement, and/or electromagnetic markers.
Electromyography
时间窗: Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13
Change in measurements of electrical activity at major muscle groups below the level of injury.
Foot pressure
时间窗: Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13
Change in measurements of foot pressure through shoe-insole pressure sensors.
Somatosensory evoked potentials
时间窗: Baseline, Month 6, End of Month 7, Month 13
Change in measurements of change in conduction in the peripheral nerves, cervical and lumbosacral spinal cord, deep brain structures, and sensory cortex, through surface electrodes.
Transcranial magnetic stimulation motor evoked potentials
时间窗: Baseline, Month 6, End of Month 7, Month 13
Change in measurements of stimulus intensity required to elicit muscle responses in muscle groups known to elicit optimal motor evoked potential responses, both above and below the level of injury.
Monosynaptic spinal reflex testing
时间窗: Baseline, Month 6, End of Month 7, Month 13
Change in measurements of stimulation intensity H and F wave thresholds and maximal responses through surface electrodes.
Trunk stability
时间窗: Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13
Change in measurements of trunk stability using the modified functional reach test (mFRT).
Injury severity: American Spinal Injury Association Impairment Scale (AIS)
时间窗: Baseline, Month 6, End of Month 7, Month 13
Change in measurements of impairment of sensory and motor functions using the American Spinal Injury Association Impairment Scale (AIS). Individuals are classified from A" (complete spinal cord injury) to "E" (normal function). 28 dermatomes and 10 key muscles are assessed bilaterally. Results are summed to produce overall sensory and motor scores and are used in combination with evaluation of anal sensory and motor function as a basis for the determination of AIS classification. Sensory scores are rated 0 (sensation absent) to 2 (normal), bilaterally for each of 28 dermatomes. Muscle function is rated 0 (total paralysis) to 5 (active movement, full range of motion against significant resistance) for each myotome. Upper Extremity Motor Subscores and Lower Extremity Motor Subscores are each scored from 0 to 50; the ASIA Motor Score is scored from 0 to 100. The presence of anal sensation and voluntary anal contraction are assessed as a yes/no.
次要结局
- Spinal structural integrity(Baseline)
- Bowel function(Baseline, Month 6, Month 13)
- Bladder function(Baseline, Month 6, Month 13)
- Spasticity(Baseline, Month 3, Month 6, End of Month 7, Month 10, Month 13)
- Bone mineral density(Baseline, Month 6, Month 13)
- Body composition - body fat mass(Baseline, Month 6, End of Month 7, Month 13)
- Body composition - lean mass(Baseline, Month 6, End of Month 7, Month 13)
- Body composition - android and gynoid fat percentage(Baseline, Month 6, End of Month 7, Month 13)
- Body composition - android and gynoid fat ratio(Baseline, Month 6, End of Month 7, Month 13)
- Body composition - bone mass(Baseline, Month 6, End of Month 7, Month 13)
- Knee cartilage health(Baseline, Month 6; Month 13 for TESS cohort only)
- Metabolics - CBC(Baseline, Month 6, End of Month 7, Month 13)
- Male patient-reported sexual function (1)(Baseline, Month 6, End of Month 7, Month 13)
- Male patient-reported sexual function (2)(Baseline, Month 6, End of Month 7, Month 13)
- Male patient-reported sexual function (3)(Baseline, Month 6, End of Month 7, Month 13)
- Female patient-reported sexual function (1)(Baseline, Month 6, End of Month 7, Month 13)
- Female patient-reported sexual function (2)(Baseline, Month 6, End of Month 7, Month 13)
- Patient-reported quality of life (1): Spinal Cord Injury Secondary Conditions Scale (SCI-SCS)(Baseline, Month 6, End of Month 7, Month 13)
- Metabolics - glucose(Baseline, Month 6, End of Month 7, Month 13)
- Metabolics - total cholesterol(Baseline, Month 6, End of Month 7, Month 13)
- Metabolics - HDL cholesterol(Baseline, Month 6, End of Month 7, Month 13)
- Metabolics - calculated LDL cholesterol(Baseline, Month 6, End of Month 7, Month 13)
- Metabolics - triglycerides(Baseline, Month 6, End of Month 7, Month 13)
- Metabolics - non-HDL cholesterol(Baseline, Month 6, End of Month 7, Month 13)
- Injury severity and potential for spared tissue(Baseline)
- Stimulator array location and migration (EES cohort only)(End of Month 7, Month 13)
- Patient-reported bowel function (1)(Baseline, Month 6, End of Month 7, Month 13)
- Patient-reported bowel function (2)(Baseline, Month 6, End of Month 7, Month 13)
- Patient-reported bladder function (1)(Baseline, Month 6, End of Month 7, Month 13)
- Patient-reported bladder function (2)(Baseline, Month 6, End of Month 7, Month 13)
- Patient-reported quality of life (2): World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)(Baseline, Month 6, End of Month 7, Month 13)
研究者
Kristin Zhao, PhD
Principal Investigator
Mayo Clinic