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

Официальное название

A Randomized Controlled Trial of High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) for the Treatment of Essential Hypertension

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство Active 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).
• Устройство Sham High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS)
  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).

Первичные конечные точки

• Difference in systolic blood pressure at end of treatment [Срок оценки: From baseline to week 4 (end of treatment)]

Вторичные конечные точки (5)

• Difference in systolic blood pressure at week 12 [Срок оценки: From baseline to week 12]
• Difference in diastolic blood pressure at the end of treatment [Срок оценки: 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 [Срок оценки: From baseline to week 4 (end of treatment)]
• Difference in rate of achieving target blood pressure at the end of treatment [Срок оценки: From baseline to week 4 (end of treatment)]
• Difference in proportion of achieving target blood pressure at week 12 [Срок оценки: From baseline to week 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• 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.
• Skin lesions, eczema, or broken skin at the intended electrode placement sites.
• Participation in another clinical trial involving an investigational product or device within 30 days prior to screening.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xuanwu Hospital, Capital Medical University — Пекин

Публикации

• Wang HX, Wang L, Zhang WR, Xue Q, Peng M, Sun ZC, Li LP, Wang K, Yang XT, Jia Y, Zhou QL, Xu ZX, Li N, Dong K, Zhang Q, Song HQ, Zhan SQ, Min BQ, Fan CQ, Zhou AH, Guo XH, Li HB, Liang LR, Yin L, Si TM, Huang J, Yan TY, Cosci F, Kamiya A, Lu J, Wang YP. Effect of Transcranial Alternating Current Stimulation for the Treatment of Chronic Insomnia: A Randomized, Double-Blind, Parallel-Group, Placebo-C PMID 31846980
• Liu X, Wang K, Si T, Zhang X, Cosci F, Gao K, Wang H. The role of 15 mA and 77.5 Hz transcranial alternating current stimulation in blood pressure regulation: A post hoc analysis of a randomized controlled trial. J Affect Disord. 2025 Apr 1;374:91-98. doi: 10.1016/j.jad.2025.01.017. Epub 2025 Jan 9. PMID 39798713

Идентификаторы

NCT: NCT07566650 · Hi-tACS for HBP · HZ2025PYLJ003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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