Multi-Channel Spinal Transcutaneous Electrical Pulsed Stimulation System: STEPSS
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
- Leg EMG activity during spinal stimulation
研究概览
简要总结
The purpose of this study is to compare updated spinal stimulation devices with the spinal stimulation device that is currently used. Spinal stimulation is often used in studies aimed at assisting individuals with a spinal cord injury. These devices were updated to improve upon limitations in the currently used device. The devices will be compared in a group of people without spinal cord injury or other nervous system conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age
- •Proficient in English
- •Available for the testing session
- •Able to give informed consent
- •Able to tolerate spinal stimulation
排除标准
- •Pregnant (female only).
- •Untreated severe and persistent problems regulating blood pressure, heart rate, or other automatic functions.
- •Any past or present injury or disease to the nervous system
- •Heart or lung disease that may interfere with stimulation
- •A skin condition in any area that may affect the ability to receive stimulation
- •Taking any medication that may affect the ability to receive spinal stimulation
- •Ongoing drug abuse
研究组 & 干预措施
Healthy Participants
干预措施: Spinal Stimulation (Device)
结局指标
主要结局
Leg EMG activity during spinal stimulation
时间窗: up to 6 weeks
Participants will have electrodes connected to the STEPPS stimulator, placed over spinal site locations (T10/11 \& T11/12). These electrodes will send an electrical current to their spine while laying on their back. Additional electrodes will be placed over right leg muscles to measure leg EMG muscle activation during the spinal stimulation. The same procedures will be used for the ARC-ex stimulator. Four trials of each stimulation device with EMG recording will be given over the course of 4 hours each visit for 3 visits. Mean/standard deviation curves and correlation coefficients for right leg muscle activation will be calculated to compare curves for NRT (pre-existing data) and each stimulator.
Leg EMG activity during STEPPS spinal stimulations
时间窗: up to 6 weeks
Participants will have electrodes connected to the STEPPS stimulator, placed over spinal site locations (T10/11 \& T11/12). These electrodes will send an electrical current to their spine while laying on their back. Additional electrodes will be placed over right leg muscles to measure leg EMG muscle activation during the spinal stimulation. Four trials of stimulation with EMG recording will be given over the course of 2 hours each visit for 3 visits. Mean/standard deviation curves and correlation coefficients for right leg muscle activation will be calculated to compare curves for NRT (pre-existing data) and STEPSS stimulators.
次要结局
未报告次要终点
研究者
Gail Forrest
Director, Tim and Caroline Reynolds Center for Spinal Stimulation
Kessler Foundation