High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) for Hypertension: A Randomized Controlled Trial
29 april 2026 bijgewerkt door: Xuanwu Hospital, Beijing
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
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
50
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Hongxing Wang, MD & PhD
- Telefoonnummer: +86 13911127385
- E-mail: wanghongxing@xwh.ccmu.edu.cn
Studie Locaties
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China
- Xuanwu Hospital, Capital Medical University
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
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-vergelijker: 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).
|
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).
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Difference in systolic blood pressure at end of treatment
Tijdsspanne: 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)
|
From baseline to week 4 (end of treatment)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Difference in systolic blood pressure at week 12
Tijdsspanne: From baseline to week 12
|
Comparison of the change from baseline in diastolic blood pressure between the two groups at week 12
|
From baseline to week 12
|
|
Difference in diastolic blood pressure at the end of treatment
Tijdsspanne: From baseline to week 4 (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)
|
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
Tijdsspanne: From baseline to week 4 (end of treatment)
|
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)
|
From baseline to week 4 (end of treatment)
|
|
Difference in rate of achieving target blood pressure at the end of treatment
Tijdsspanne: From baseline to week 4 (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）
|
From baseline to week 4 (end of treatment)
|
|
Difference in proportion of achieving target blood pressure at week 12
Tijdsspanne: From baseline to 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
|
From baseline to week 12
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 mei 2026
Primaire voltooiing (Geschat)
1 oktober 2027
Studie voltooiing (Geschat)
1 mei 2028
Studieregistratiedata
Eerst ingediend
16 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
29 april 2026
Eerst geplaatst (Werkelijk)
5 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
5 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
29 april 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Hi-tACS for HBP
- HZ2025PYLJ003 (Ander subsidie-/financieringsnummer: Xuanwu Hospital, Capital Medical University)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .