Cardiopulmonary Changes Following Spinal Cord Stimulation in Individuals With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Circulating endothelial biomarkers in EMV/µL (Park et al., 2023)
研究概览
简要总结
The aim of this study is to examine the mechanisms of transcutaneous spinal cord stimulation (tSCS) for improving cardiovascular and pulmonary function in individuals with chronic motor-complete spinal cord injury (SCI) by measuring vascular related endothelial biomarkers, plasma catecholamines, and respiratory parameters.
详细描述
DETAILED RESEARCH PROCEDURES
(A) INFORMED CONSENT:
Prospective participants will be provided with the study informed consent form and will be given at least 24 hours to review the form, ask questions, and discuss with whomever they like.
(B) VISIT 1 -Screening
Approximately 1 hour
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
- 19 Years 至 65 Years（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
Circulating endothelial biomarkers in EMV/µL (Park et al., 2023)
时间窗: Real-time Effect: 1 week; Long-term Effect: 8 weeks
Real-time Effect: Change in circulating endothelial biomarkers (i.e., endothelial cell derived microvesicles (EMVs)) before and after real-time tSCS during cardiovascular stress (i.e., head-up tilt test to trigger orthostatic hypotension OH and/or vibrostimulation/DARS to trigger AD). Long-term Effect: Change from baseline in circulating endothelial biomarkers (i.e., endothelial cell derived microvesicles (EMVs)) before and after long-term tSCS intervention during cardiovascular stress (i.e., head-up tilt test to trigger OH and/or vibrostimulation/DARS to trigger AD).
次要结局
- Spirometric parameters for lung volume in ml/kg (Aung et al., 2019) for FVC(Real-time Effect: 1 week; Long-term Effect: 8 weeks)
- Spirometric parameters for lung volume in ml/kg (Aung et al., 2019) for FEV1(Real-time Effect: 1 week; Long-term Effect: 8 weeks)
- Plasma catecholamines in nmol/L (Claydon & Krassioukov, 2008)(Real-time Effect: 1 week; Long-term Effect: 8 weeks)
研究者
Andrei Krassioukov
Principal Investigator
University of British Columbia