Primary HypertensionNCT07566650
High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) for Hypertension: A Randomized Controlled Trial
A study testing Active High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) in people with Primary Hypertension, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Hypertension
- What is being tested?
- Active High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality
About this study
Official title: A Randomized Controlled Trial of High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) for the Treatment of Essential Hypertension
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
Read the detailed description
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.
- Conditions
- Primary Hypertension
- Being tested
- Active High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS), Sham High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS)
- Keywords
- transcranial alternating current stimulation, autonomic nervous system, neuromodulation, primary hypertension
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: Sham High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From baseline to week 4 (end of treatment)
Secondary outcomes (5)
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
Measured: 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)
Measured: 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)
Measured: 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）
Measured: 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
Measured: From baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary HypertensionStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566650
- Sponsor's protocol ID
- Hi-tACS for HBP
- Other IDs
- HZ2025PYLJ003
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31846980Liu 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.
PubMed 39798713
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) for the Treatment of Essential Hypertension
- ClinicalTrials.gov ID
- NCT07566650
- Acronym / sponsor ID
- Hi-tACS for HBP
- Conditions
- Primary Hypertension
- Keywords
- transcranial alternating current stimulation, autonomic nervous system, neuromodulation, primary hypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) | Experimental | Device: Active High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS)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. |
| Sham High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) | Sham comparator | Device: Sham 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Active High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) |
| 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). | Device | Sham High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) |
Primary outcome
Difference in systolic blood pressure at end of treatment
Time frame: From baseline to week 4 (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)
5 secondary outcomes
Difference in systolic blood pressure at week 12
Time frame: From baseline to week 12
Difference in diastolic blood pressure at the end of treatment
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
Time frame: From baseline to week 4 (end of treatment)
Difference in rate of achieving target blood pressure at the end of treatment
Time frame: From baseline to week 4 (end of treatment)
Difference in proportion of achieving target blood pressure at week 12
Time frame: From baseline to week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Results publication: PubMed 31846980Wang 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.
- Results publication: PubMed 39798713Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) in people with Primary Hypertension, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongxing Wang, MD & PhD (+86 13911127385, wanghongxing@xwh.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in systolic blood pressure at end of treatment (time frame: From baseline to week 4 (end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07566650, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.