Efficacy and Safety Evaluation of Non-invasive Temporal Interference Stimulation for Blood Pressure Regulation

Other illness

• Patients with secondary hypertension;
• Individuals unable to cooperate due to mental illness or other reasons;
• Patients with cardiac insufficiency;
• Individuals with a high risk of cerebrovascular disease confirmed by transcranial magnetic resonance imaging (MRI).

Other

• Patients with intracranial structural lesions (e.g., infarcts, vascular malformations, space-occupying lesions, etc.);
• Pregnant women;
• 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 excluding those with white coat effect;

• 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).