High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) for Hypertension: A Randomized Controlled Trial

Prior treatment

• Participation in another clinical trial involving an investigational product or device within 30 days prior to screening.

Other illness

• Resistant hypertension (blood pressure uncontrolled despite adherence to ≥3 antihypertensive drugs of different classes at optimal doses, including a diuretic ), or known secondary hypertension.
• Uncontrolled sleep apnea syndrome, active infectious diseases, chronic wasting diseases, or significant cognitive impairment.
• Current major psychiatric disorder as assessed by the Mini-International Neuropsychiatric Interview (M.I.N.I.).
• Contraindications to tACS or MRI: implanted electronic devices, intracranial metal implants, or known history of seizures.
• Any condition that, in the opinion of the investigator, would jeopardize the patient's safety or compliance with the study protocol, or interfere with data interpretation.

Lab values

• History of severe cardiovascular or cerebrovascular disease (e.g., myocardial infarction, stroke, heart failure NYHA Class III-IV) within the past 6 months, or severe hepatic or renal dysfunction (defined as ALT/AST \>3× upper limit of normal \[ULN\], or eGFR \<30 mL/min/1.73 m²).

Other

• Women who are pregnant, breastfeeding, or planning pregnancy during the study period.
• Skin lesions, eczema, or broken skin at the intended electrode placement sites.

• Clinical diagnosis of primary hypertension (Grade 1-3) as defined by the Chinese Hypertension Guidelines (Revised Edition 2024).
• For females of childbearing potential, agreement to use contraception during the study.
• Willing and able to comply with study procedures and provide written informed consent.