This study focuses on individuals with primary hypertension, with the main objective of investigating the effectiveness and safety of high-intensity transcranial alternating current stimulation (Hi-tACS) as a non-invasive, non-pharmacological treatment for hypertension
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.
Women who are pregnant, breastfeeding, or planning pregnancy during the study period.
Resistant hypertension (blood pressure uncontrolled despite adherence to ≥3 antihypertensive drugs of different classes at optimal doses, including a diuretic ), or known secondary hypertension.
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).
Uncontrolled sleep apnea syndrome, active infectious diseases, chronic wasting diseases, or significant cognitive impairment.
Parallel
Active High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS)
DeviceActive Hi-tACS delivered using a transcranial alternating current stimulation device. Parameters: 77.5 Hz sinusoidal alternating current, 15 mA (peak-to-peak), 40 minutes per session. Electrode montage: one 8 cm × 4 cm electrode placed horizontally on the forehead (covering Fpz, Fp1, Fp2 regions) and two 6 cm × 2.9 cm electrodes placed on bilateral mastoid regions. Conductive gel ensures impedance \<10 kΩ. One session/day, 5 days/week for 4 weeks (total 20 sessions).
Sham High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS)
DeviceSham stimulation using the same device and electrode placement as the active arm. Active stimulation is applied only for the first 30 seconds, then ramped down to 0 mA over 10 seconds. For the remaining session duration, intermittent low-intensity signals producing imperceptible skin sensation are delivered to maintain blinding. Same schedule: 40 minutes/session, one session/day, 5 days/week for 4 weeks (total 20 sessions).
Difference in systolic blood pressure at end of treatment
Comparison of the change from baseline in systolic blood pressure between the two treatment groups at the end of treatment (week 4)
Difference in systolic blood pressure at week 12
Comparison of the change from baseline in diastolic blood pressure between the two groups at week 12
Difference in diastolic blood pressure at the end of treatment
Comparison of the change from baseline in diastolic blood pressure (DBP) between the two groups at the end of treatment (week 4)
Difference in 24-hour ambulatory blood pressure parameter at the end of treatment: Mean 24-hour systolic blood pressure
Comparison of the change from baseline in mean 24-hour systolic blood pressure between the two treatment groups at the end of treatment (week 4)
Difference in rate of achieving target blood pressure at the end of treatment
Comparison of the proportion of patients achieving target blood pressure (defined as SBP/DBP \<140/90 mmHg, or \<130/80 mmHg for those with diabetes or chronic kidney disease) between the two groups at end of treatment （week 4）
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