Direct Electrical Stimulation of Central Autonomic Network for Blood Pressure Control: a Mechanism Study
The primary objective of this research is to study direct electrical stimulation of central autonomic network for blood pressure control.
研究概览
详细说明
This project aims to include 20 participants, and evaluate the direct electrical stimulation of central autonomic network for blood pressure control through A pilot, prospective clinical trial. It is expected to explore potential blood pressure regulation-related targets in the central autonomic neural network and provide a neuromodulation approach for the treatment of blood pressure disorders, including refractory hypertension and neurogenic orthostatic hypotension.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Liankun Ren, MD
- 电话号码：+86 13681576621
- 邮箱：renlk2022@outlook.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Aged 18-60 years, with no gender restrictions.
- Free from severe systemic diseases.
- Patients who have undergone stereoelectroencephalography electrode implantation.
- Patients who have been informed of potential risks, consented to participate in this study, and signed the informed consent form.
- Daytime clinic blood pressure fluctuates within the following range: 90 mmHg < systolic blood pressure < 140 mmHg; 60 mmHg < diastolic blood pressure < 90 mmHg.
Exclusion Criteria:
- Patients with scalp electrode hematoma or sub-electrode effusion after intracranial electrode implantation, who are unable to receive electrical stimulation.
- Patients with intracranial structural lesions (e.g., encephalomalacia foci, vascular malformations, space-occupying lesions, etc.).
- Pregnant women.
- Patients who are unable to cooperate due to mental disorders or other causes.
- Patients who have participated in other clinical trials within the past 3 months.
- Patients who apply to withdraw from this clinical trial for any reason.
- Patients with cardiac or pulmonary insufficiency.
- Patients with white coat effect are excluded.
- Patients with low cerebrovascular risk assessed by cranial magnetic resonance imaging (MRI).
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Direct electrical stimulation
Patients with hypertension and drug-resistant focal epilepsy who underwent intracranial monitoring via stereotactically implanted depth electrodes (SEEG) are assigned to Direct electrical stimulation for 30 sec per mission. |
The intervention consists of direct electrical stimulation delivered at three distinct frequencies (10 Hz, 50 Hz, and 120 Hz). A double-blind design will be employed to randomly assign one of these frequencies for a 30-second direct electrical stimulation session in each patient. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
blood pressure
大体时间：up to 4 hours
|
Blood Pressure is defined as the blood pressure measurement obtained 30 minutes after the completion of direct electrical stimulation. |
up to 4 hours
|
合作者和调查者
调查人员
- 首席研究员：Liankun Ren, MD、Xuanwu Hospital, Beijing
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.