Hemodynamic Effects of Transcutaneous Spinal Cord Stimulation During Passive Orthostasis: a Prospective Single-center Randomized Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Systolic blood pressure drop correction
研究概览
简要总结
This is a prospective single-center randomized crossover control study that aims to evaluate the effects of non-invasive transcutaneous spinal cord stimulation in patients with known or suspected orthostatic hypotension.
详细描述
The hypothesis is that transcutaneous spinal cord stimulation at thoracic level may correct hypotensive episodes during tilt testing in subjects with blood pressure drops.
Eligible patients will sign an informed consent form before the procedure. Non-invasive transcutaneous electrical stimulation of the spinal cord will be applied using modulated electrical impulses through external adhesive electrode patches connected to a neural stimulator device. The study protocol includes analysis of the following parameters: heart rate; 12-lead electrocardiogram; continuous beat-to-beat blood pressure recordings (measured noninvasively by plethysmography) before stimulation, during stimulation and after spinal cord stimulation. All registered data will be analyzed at the end of the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Stimulation patches will be applied in all patients and simulating of stimulation will be provided by an audible order by an investigator. Since high-frequency stimulation is almost non-sensible, masking is possible.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years
- •Suspected orthostatic hypotension (having a history of syncope and/or pre-syncope that occurred during the transition to an upright position, with complaints of recurrent dizziness that occurs during the transition to an upright position) or documented orthostatic hypotension.
- •The patient who signed the informed consent form
排除标准
- •Orthostatic hypotension caused by acute hypovolemia or bleeding.
- •Chronic heart failure III-IV functional class (NYHA)
- •Structural heart disease of the following: hypertrophic cardiomyopathy with obstruction of the left ventricular outflow tract, acute coronary syndrome, restrictive cardiomyopathy, hemodynamically significant valvular heart defects, uncorrected hemodynamically significant congenital heart defects.
- •Ongoing acute illness.
- •>90% paced cardiac rhythm.
- •Permanent atrial fibrillation.
- •A history of transient ischemic attack or stroke within 3 months before the enrollment and/or incomplete recovery.
- •Pulmonary embolism <1 month ago.
- •The presence of an implantable pump.
- •Patients with contraindications to the use of the patch electrodes used in this study, as indicated in the relevant instructions for use.
研究组 & 干预措施
Spinal cord stimulation
Before tilt testing, adhesive patches are applied to subjects' back skin. Single stimuli are delivered to the patches in order to define the stimulation threshold under the guidance of neuromyography. An investigator says loudly: "I am initiating high-frequency stimulation". Stimulation is initiated within 2 min before tilting the table. Then verticalization of the table 45 degrees is performed, and the test is continued for 15-30 min. Beat-to-beat blood pressure recording is carried out and 10 min after blood pressure complete stabilization the test is ended.
干预措施: Spinal cord stimulation (Procedure)
Sham stimulation
Before tilt testing, adhesive patches are applied to subjects' back skin. Single stimuli are delivered to the patches in order to define stimulation threshold under the guidance of neuromyography. An investigator says loudly: "I am initiating high-frequency stimulation". No stimulation is initiated. Two minutes after, verticalization of the table 45 degrees is performed, and the test is continued for 15-30 min. Beat-to-beat blood pressure recording is carried out and 10 min after blood pressure complete stabilization the test is ended.
干预措施: Sham stimulation (Procedure)
结局指标
主要结局
Systolic blood pressure drop correction
时间窗: 5-30 minutes following verticalization
It is suggested that spinal cord stimulation will correct systolic blood pressure drop during tilt testing. The effect is expected within 5-10 mmHg as a difference between minimum systolic blood pressure during stimulation and without stimulation (sham).
次要结局
- Diastolic blood pressure drop correction(5-30 minutes following verticalization)