Safety and Efficacy Evaluation of Non-invasive Temporal Interference Stimulation for Blood Pressure Modulation in Patients With Mild Essential Hypertension

Safety and Efficacy Evaluation of Non-invasive Temporal Interference Stimulation for Blood Pressure Modulation in Patients With Mild Essential Hypertension: A Prospective, Double-blind, Randomized Controlled Trial

The primary objective of this research is to study the efficacy and safety of temporal interference stimulation for blood pressure modulation in patients with mild essential hypertension.

This project aims to include 60 participants, who are randomly assigned in a 1 ratio into two groups named TI group and sham TI group , and evaluate the effectiveness and safety of temporal interference stimulation in patients with mild essential hypertension and through A prospective, double-blind, randomized controlled clinical trial. It is expected to provide new therapeutic options for patients with mild essential hypertension with alternative treatment options.

Inclusion Criteria:

1. Aged between 30 and 65 years old.
2. Office blood pressure with systolic blood pressure (SBP) 140-159 mmHg and/or diastolic blood pressure (DBP) 90-99 mmHg.
3. No intake of any antihypertensive drugs or have discontinued antihypertensive medication for at least 3 months prior to randomization; no intention to receive any other antihypertensive therapy within the 15-week study period.
4. Written informed consent has been obtained from the subject or their legally authorized representative after being informed of the potential risks.

Exclusion Criteria:

1. Known or suspected secondary hypertension.
2. Contraindications to TI treatment or sham TI treatment, including intracranial metal implants (e.g., pacemaker, ventriculoperitoneal shunt, vascular clip), craniocerebral surgery within the last 6 months, history of intracranial tumor or hemorrhage; skin damage, infection, eczema or allergy at the stimulation site (frontal/temporal region); severe skin diseases (e.g., psoriasis).
3. Subjects with high risk of cerebrovascular disease indicated by cranial magnetic resonance imaging.
4. History of myocardial infarction or cerebral infarction.
5. Atrial fibrillation or other severe arrhythmias, such as severe bradycardia, third-degree atrioventricular block, or ventricular tachycardia.
6. Severe or unstable medical conditions, including severe hepatic dysfunction (defined as alanine transaminase or aspartate transaminase level more than 2 times the upper limit of normal), severe renal dysfunction (defined as serum creatinine level more than 1.5 times the upper limit of normal), and severe heart failure (New York Heart Association Class III and IV).
7. Females who are pregnant, breastfeeding, or planning to become pregnant within one year.
8. Individuals unable to cooperate due to mental illness or other reasons.
9. Participants enrolled in other clinical trials within 3 months prior to randomization.
10. Participants deemed ineligible for this trial for other reasons determined by the investigator.