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

NCT07566650 | Not Yet Recruiting

• 2 other identifiers: Hi-tACS for HBPHZ2025PYLJ003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Hypertension

Keywords

transcranial alternating current stimulation; autonomic nervous system; neuromodulation; primary hypertension

Outcome Measures

Primary Outcomes (1)

• 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)

  From baseline to week 4 (end of treatment)

Secondary Outcomes (5)

• Difference in systolic blood pressure at week 12

  From baseline to week 12

• Difference in diastolic blood pressure at the end of treatment

  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

  From baseline to week 4 (end of treatment)

• Difference in rate of achieving target blood pressure at the end of treatment

  From baseline to week 4 (end of treatment)

• Difference in proportion of achieving target blood pressure at week 12

  From baseline to week 12

Study Arms (2)

Active High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS)

EXPERIMENTAL

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)

Sham High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS)

SHAM COMPARATOR

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)

Interventions

Active High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) DEVICE

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).

Active High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS)

Sham High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) DEVICE

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).

Sham High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Related Publications (2)

• 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-Controlled Clinical Trial. Psychother Psychosom. 2020;89(1):38-47. doi: 10.1159/000504609. Epub 2019 Dec 17.

  PMID: 31846980 RESULT

• 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 RESULT

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Hongxing Wang, MD & PhD

CONTACT

+86 13911127385; wanghongxing@xwh.ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind, randomized, sham-controlled trial. Both participants and outcome assessors are masked to group assignment. The sham stimulation protocol delivers only 30 seconds of low-intensity current at the start and end of each session to mimic the transient scalp sensation of active high-intensity transcranial alternating current stimulation (Hi-tACS), ensuring the integrity of blinding. The statistician responsible for data analysis will also remain masked to group allocation until the final statistical analysis is completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)