Neuromodulation With Spinal Stimulation Methods
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Motor evoked potentials
研究概览
简要总结
This is a pilot research study to test the protocols needed for transcutaneous spinal electrical stimulation in persons living with spinal cord injury (SCI). Up to 24 participants will be enrolled. A variety of stimulation parameters and outcome measures will be assessed.
详细描述
Purpose of this project
Spinal cord stimulation has the potential to improve motor function recovery after spinal cord injury. Commonly used approaches include low-intensity, direct current (DC) stimulation applied across multiple segments, electrical transcutaneous (ETC) stimulation, and magnetic transcutaneous stimulation (MTC).
Objective
to evaluate and compare the voluntary and reflexive motor performance in the same subjects, including people with and without spinal cord injury, after non-invasive spinal cord stimulation interventions. Comparing two different interventions applied in different experimental sessions and the respective sham stimulation is the goal of this study.
corticospinal and spinal motor pathways in paraplegics and in non-injured humans will be tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participant will be connected to the stimulation device(s) but will not know if it has been turned on during each trial. In addition, the person analyzing the outcome data will not be aware of the stimulation status of the participant.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •spinal cord injury C4 to L4
- •ability to understand and follow directions
排除标准
- •history of seizures, head injury, concussion, unexplained loss of consciousness or if they lived with an implanted cochlear stimulator, brain/neurostimulator, cardiac pacemaker, medication infusion device or live with metal implants in their body or if they are pregnant.
研究组 & 干预措施
Spinal cord stimulation
Spinal cord stimulation will be administered to participants for 15 min.
干预措施: spinal stimulation-DCS (Device)
Spinal cord stimulation
Spinal cord stimulation will be administered to participants for 15 min.
干预措施: spinal stimulation-EPS (Other)
Shamspinal cord stimulation
Sham spinal cord stimulation will be administered to participants for 15 min.
干预措施: spinal stimulation-sham DCS (Other)
Shamspinal cord stimulation
Sham spinal cord stimulation will be administered to participants for 15 min.
干预措施: sham spinal stimulation-EPS (Other)
结局指标
主要结局
Motor evoked potentials
时间窗: Immediately after stimulation (within 1-15 min)
MEP input-output curve
Motor response
时间窗: Immediately after stimulation (within 1-15 min)
H-reflex input output curve
次要结局
- Blood pressure(During the procedure/stimulation and up to 15 min after stimulation.)
- Perception of discomfort due to stimulation(During and after procedure/stimulation and up to 15 min after stimulation.)