An interventional study of Active High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) and Sham High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) in Primary Hypertension, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment
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
Hypertension is a highly prevalent cardiovascular disease and a major risk factor for stroke, heart failure, and kidney disease. Many patients continue to have poorly controlled blood pressure despite standard medication, which may be due to excessive activity of the central sympathetic nervous system and poor long-term compliance. Conventional antihypertensive drugs mainly act on peripheral targets and lack regulation of the brain-heart axis, leaving a large clinical need for safe, non-pharmacological adjuvant treatments.
High-intensity transcranial alternating current stimulation (Hi-tACS) is a non-invasive neuromodulation technique that can modulate central autonomic networks and normalize sympathetic-parasympathetic balance. Recent studies and our preliminary data suggest that 77.5 Hz, 15 mA Hi-tACS may safely reduce blood pressure in individuals with elevated baseline levels. Therefore, we hypothesize that Hi-tACS can lower blood pressure in patients with primary hypertension by regulating brain autonomic function and reducing sympathetic overactivity.
This study aims to evaluate the efficacy and safety of Hi-tACS in adults with primary hypertension, explore its underlying neural and physiological mechanisms, and provide high-quality evidence for a new non-pharmacological approach to hypertension management.
527 studies on the registry are indexed under Essential Hypertension; 76 are open to participants now.
This study's planned enrollment of 50 is below the median of 166 across 449 interventional studies indexed under Essential Hypertension.
Browse Essential Hypertension studies →Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.
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Participants receive high-intensity transcranial alternating current stimulation (Hi-tACS) at 77.5 Hz, 15 mA for 40 minutes per session, one session per day, 5 days per week, for 4 weeks (total 20 sessions). Electrodes are placed on the forehead (Fpz, Fp1, Fp2 regions) and bilateral mastoid regions.
Device: Active High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS)
Participants receive sham stimulation with the same electrode placement. Active stimulation is delivered only for the first 30 seconds, then ramped down to 0 mA over 10 seconds, with intermittent imperceptible skin-sensation signals for the remaining 40-minute session to mimic real stimulation. Same session schedule (20 sessions over 4 weeks).
Device: Sham High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS)
Active 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 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)
Time frame: From baseline to week 4 (end of treatment)
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
Time frame: From baseline to 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)
Time frame: From baseline to week 4 (end of treatment)
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)
Time frame: From baseline to week 4 (end of treatment)
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）
Time frame: From baseline to week 4 (end of treatment)
Difference in proportion of achieving target blood pressure at week 12
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 week 12
Time frame: From baseline to week 12
Plan to share: No
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Xuanwu Hospital, Beijing