Not Yet RecruitingNot Applicable

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

China25 participantsStarted 2025-12-01

Plain-language summary

The primary objective of this research is to study the efficacy and safety of temporal interference stimulation for regulating the blood pressure.

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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;

Blood Pressure (BP24)

Timeframe: Up to 12 weeks after temporal interference stimulation

NCT IDNCT07239492

SponsorXuanwu Hospital, Beijing

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-01

Liankun Ren, MD

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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;