Characterizing the Effect of Epidural Electrical Stimulation on Blood Pressure in Hypertensive Individuals With Implanted Spinal Cord Stimulators
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in Diastolic Blood Pressure Across Spinal Cord Stimulation Conditions
研究概览
简要总结
High blood pressure, also called hypertension, raises the risk of heart disease, stroke, and kidney disease. Medications work well for many people, but some people still have blood pressure that stays too high, or they have side effects from their medications. Researchers are looking for treatments that do not involve taking more medication.
Nerves help control blood pressure by changing how blood vessels tighten and how hard the heart pumps. Because of this, treatments that act on nerves may be able to lower blood pressure.
Spinal cord stimulation is a treatment already used to manage long-term pain. It uses a small device, placed under the skin during a standard operation, that sends mild electrical signals to the spine. Laboratory studies suggest that stimulating the lower part of the mid-back may also lower blood pressure, but this has not been carefully studied in people who already use these devices.
This study will look at whether changing the settings on a spinal cord stimulator affects blood pressure. About 11 adults who have high blood pressure and who already have a spinal cord stimulator for long-term pain. No new device will be placed, and no surgery or other invasive procedure will be done for this study.
Participants attend a series of study visits. At each visit, trained staff record blood pressure and heart rate while the stimulator is turned on, turned off, and set to other settings that the person's care team has approved and that the person finds comfortable. There are rest breaks between each setting. Over successive visits, the study team works to identify the settings that best lower blood pressure. Participants can stop at any time, and their usual settings are restored at the end of each visit.
The study will also look at whether this kind of testing is practical and comfortable for participants. The results will help researchers decide whether larger studies of spinal cord stimulation for blood pressure control are worth doing.
详细描述
Hypertension is a major modifiable risk factor for cardiovascular disease, stroke, heart failure, and chronic kidney disease. Although effective antihypertensive medications are available, a proportion of individuals have inadequately controlled blood pressure, experience adverse medication effects, or require multiple agents to reach target. This has sustained interest in adjunctive, non-pharmacological approaches to blood pressure management.
The autonomic nervous system regulates blood pressure through modulation of vascular tone, cardiac output, and reflex control mechanisms, and elevated sympathetic activity is implicated in the pathogenesis and maintenance of hypertension. Device-based therapies including renal denervation and baroreflex activation therapy provide proof of concept that targeted neuromodulation can lower arterial pressure.
Spinal cord stimulation is an established clinical therapy for chronic pain. Individuals with implanted lower thoracic spinal cord stimulators represent a population in which the cardiovascular effects of spinal neuromodulation can be examined without exposing participants to a new implantation procedure. Preclinical work indicates that stimulation of lower thoracic spinal segments can acutely reduce arterial blood pressure through modulation of autonomic pathways; these effects have not been well characterized in humans with existing systems.
Study procedures: Participants attend a series of study visits conducted in a monitored clinical or research setting. Stimulation parameters are iteratively optimized across visits to identify settings that reduce blood pressure. Baseline assessment includes demographic information, relevant medical history, medication review (including antihypertensive and analgesic medications), and resting blood pressure and heart rate. Continuous or repeated non-invasive blood pressure monitoring is performed throughout the session; additional monitoring may include electrocardiography and pulse oximetry.
Stimulation testing is performed using the participant's own implanted system by personnel qualified in spinal cord stimulator programming. Adjustments remain within clinically approved device parameters and within participant tolerance. Rest periods are provided between conditions to allow return toward baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •Adults aged 18 years or older
- •Existing implanted spinal cord stimulator with leads positioned in the lower thoracic region as part of routine clinical treatment for chronic pain
- •Device functioning appropriately and participant cleared for routine programming adjustments by the treating clinical team
- •Able to understand study procedures and provide informed consent
- •Able to attend the study visit and tolerate temporary monitoring and stimulation testing
- •Documented hypertension or current use of antihypertensive medication
排除标准
- •Inability or unwillingness to provide informed consent
- •Pregnancy, if deemed clinically relevant by investigators or treating physicians
- •Unstable cardiovascular disease (e.g., uncontrolled arrhythmia, recent myocardial infarction, severe symptomatic hypotension, hypertensive emergency, or other conditions where stimulation testing may increase risk)
- •Acute illness or infection at the time of study visit
- •Implanted stimulator malfunction or clinical concerns regarding device use
- •Severe cognitive impairment or communication barriers preventing safe participation
- •Any other medical or clinical reason identified by the investigator or treating clinician that would make participation unsafe
研究组 & 干预措施
Spinal Cord Stimulation Testing
Adults with an existing implanted lower thoracic spinal cord stimulator for chronic pain undergo non-invasive cardiovascular monitoring during a series of stimulation conditions delivered through their own device. Conditions may include stimulation off, the participant's usual clinical program, and predefined alternative settings within clinically approved device parameters and participant tolerance, with rest periods between conditions.
干预措施: Lower Thoracic Spinal Cord Stimulation (Device)
结局指标
主要结局
Change in Diastolic Blood Pressure Across Spinal Cord Stimulation Conditions
时间窗: Through study completion, an average of 1 year
Change in diastolic blood pressure measured by validated non-invasive automated monitoring, compared across spinal cord stimulation conditions (stimulation off, the participant's usual clinical program, and predefined alternative settings).
Change in Systolic Blood Pressure Across Spinal Cord Stimulation Conditions
时间窗: Through study completion, an average of 1 year
Change in systolic blood pressure measured by validated non-invasive automated monitoring, compared across spinal cord stimulation conditions (stimulation off, the participant's usual clinical program, and predefined alternative settings).
Change in Mean Arterial Pressure Across Spinal Cord Stimulation Conditions
时间窗: Through study completion, an average of 1 year
Change in mean arterial pressure measured by validated non-invasive automated monitoring, compared across spinal cord stimulation conditions (stimulation off, the participant's usual clinical program, and predefined alternative settings).
次要结局
- Number of Participants Reporting Stimulation-Related Symptoms(Up to 12 months)
- Time to Onset of Blood Pressure Change Following Change in Stimulation Condition(Up to 12 months)
- Change in Heart Rate Across Spinal Cord Stimulation Conditions(up to 12 months)
- Number of Participants Completing the Full Testing Protocol(Up to 12 months)
- Duration of Blood Pressure Change Following Change in Stimulation Condition(Up to 12 months)
- Peak Magnitude of Blood Pressure Change Following Change in Stimulation Condition(Up to 12 months)