Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury: Short and Long-Term Effects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Systolic blood pressure
研究概览
简要总结
The purpose of this study is to learn whether stimulation applied to the spinal cord through the skin (called transcutaneous spinal stimulation) can help control blood pressure in people with a spinal cord injury.
The main questions this study attempts to solve:
- What are the immediate effects of spinal cord transcutaneous stimulation on BP?
- Does stimulation produce lasting improvements in BP regulation and subsequently, daily function?
详细描述
We want to find out if this stimulation can help both right away (during a session) and over time (after several sessions). Specifically, this study will look at whether spinal stimulation can treat orthostatic hypotension, which is a drop in blood pressure that happens when the patient moves from lying down to sitting or standing up. To take part, one must have had a spinal cord injury for more than one year.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with a SCI ≥ 1 year after injury
- •Injury level ≥ T6 (thoracic level)
- •AIS grade A-C
- •Cardiovascular dysfunction characterized by one or more of the following:
- •Persistent hypotension (SBP < 90mmHg)
- •Orthostatic hypotension (OH, a drop of 20/10 mmHg in SBP/DBP within 5 minutes of standing/upright positioning).
- •Additionally, experiencing orthostatic symptoms in daily life and/or requiring medication to manage OH.
排除标准
- •Current illness (e.g., infection, a pressure injury that might interfere with the intervention)
- •Ventilator-dependent
- •History of implanted brain/spine/nerve stimulators
- •Cardiac pacemaker/defibrillator or intra-cardiac lines
- •Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction
- •History of seizures
- •pregnancy
- •Insufficient mental capacity to understand and independently provide consent
- •Deemed unsuitable by the study physician
研究组 & 干预措施
participants with chronic SCIs.
Participation in this study will take about 5 to 6 months and will include approximately 30 to 40 separate lab visits. Most visits will last about 2 hours, though some of the early visits may take longer.
The study consists of:
- Baseline assessments, including a tilt test and various cardiovascular assessments
- Mapping stimulation sessions - several days when different stimulation parameters and locations are tested in order to obtain the configurations for the most suitable blood pressure response.
- Repeat tilt test, with stimulation (intervention 1), with continuous blood pressure monitoring
- 20 stimulation sessions, each 30-min long, with participants in their wheelchairs (intervention 2)
- Repeat baseline assessments
干预措施: 20 sessions of stimulation (Intervention 2) (Device)
participants with chronic SCIs.
Participation in this study will take about 5 to 6 months and will include approximately 30 to 40 separate lab visits. Most visits will last about 2 hours, though some of the early visits may take longer.
The study consists of:
- Baseline assessments, including a tilt test and various cardiovascular assessments
- Mapping stimulation sessions - several days when different stimulation parameters and locations are tested in order to obtain the configurations for the most suitable blood pressure response.
- Repeat tilt test, with stimulation (intervention 1), with continuous blood pressure monitoring
- 20 stimulation sessions, each 30-min long, with participants in their wheelchairs (intervention 2)
- Repeat baseline assessments
干预措施: Tilt test with stimulation (real-time effects): Intervention 1 (Device)
结局指标
主要结局
Systolic blood pressure
时间窗: 1 month
Evaluate changes in blood pressure during an orthostatic tilt test comparing stimulation to no stimulation.
Systolic blood pressure
时间窗: Through study completion, an average of 5 months
changes in blood pressure drop with tilt (no stimulation) from baseline testing to tilt test (no stimulation) after 20 sessions of stimulation
次要结局
- duration in tilt test(Through study completion, an average of 5 months)
- Orthostatic symptoms questionnaire(Through study completion, an average of 5 months)
- 24-hour ABPM OH events - taken at home(Through study completion, an average of 5 months)
- Autonomic Dysfunction Following Spinal Cord Injury questionnaire scores(Through study completion, an average of 5 months)
- Spinal cord injury - quality of life scores(Through study completion, an average of 5 months)
- Canadian Occupational Performance Measure scores(Through study completion, an average of 5 months)
研究者
Einat Haber
Research scientist
Kessler Foundation