NCT07239492尚未招募不适用
Efficacy and Safety Evaluation of Transcranial Non-invasive Temporal Interference Stimulation for Blood Pressure Regulation: A Pilot, Prospective Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Blood Pressure (BP24)
研究概览
简要总结
The primary objective of this research is to study the efficacy and safety of temporal interference stimulation for regulating the blood pressure.
详细描述
This project aims to include 25 participants, and evaluate the effectiveness and safety of temporal interference stimulation in patients with hypertension and hypotension through A pilot, prospective clinical trial. It is expected to provide new therapeutic options for patients with hypertension and hypotension with alternative treatment options.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 years old, male or female;
- •Three groups of patients will be enrolled in the study:
- •Essential Hypertension Grade 1 (Low Risk) - Antihypertensive Medication-Naive Group: No other cardiovascular risk factors or disease history, with systolic blood pressure (SBP) ≥140 mmHg and <160 mmHg and/or diastolic blood pressure (DBP) ≥90 mmHg and <100 mmHg;
- •Essential Hypertension - Refractory Hypertension Group: Meeting one of the following conditions after intensive lifestyle intervention plus taking 3 different types of antihypertensive drugs (including thiazide diuretics) for ≥4 weeks, with each drug at the maximum dose or maximum tolerated dose: Clinic blood pressure ≥140/90 mmHg and 24-hour average ambulatory blood pressure ≥130/80 mmHg, or average home blood pressure ≥135/85 mmHg; or blood pressure can only be controlled below 140/90 mmHg with ≥4 types of antihypertensive drugs;
- •Neurogenic Orthostatic Hypotension (nOH) Group: A decrease in SBP ≥20 mmHg and/or DBP ≥10 mmHg within 3 minutes of the head-up tilt test (HUTT) and/or standing activity;
- •BMI: 18-30;
- •After being informed of the potential risks, the patient agrees to participate in this study and signs the informed consent form (ICF).
排除标准
- •Patients with secondary hypertension;
- •Patients with intracranial structural lesions (e.g., infarcts, vascular malformations, space-occupying lesions, etc.);
- •Pregnant women;
- •Individuals unable to cooperate due to mental illness or other reasons;
- •Those who have participated in other clinical studies within the past 3 months;
- •Patients who apply to withdraw from this clinical study for any reason;
- •Patients with cardiac insufficiency;
- •Patients excluding those with white coat effect;
- •Individuals with a high risk of cerebrovascular disease confirmed by transcranial magnetic resonance imaging (MRI).
结局指标
主要结局
Blood Pressure (BP24)
时间窗: Up to 12 weeks after temporal interference stimulation
Blood Pressure (BP24) is defined as 24-hour ambulatory blood pressure monitoring in each 4 weeks.
次要结局
未报告次要终点
研究者
Liankun_Ren
Professor
Xuanwu Hospital, Beijing
研究点 (1)
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