High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) for Hypertension: A Randomized Controlled Trial
29. april 2026 oppdatert av: 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
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
50
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Hongxing Wang, MD & PhD
- Telefonnummer: +86 13911127385
- E-post: wanghongxing@xwh.ccmu.edu.cn
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina
- Xuanwu Hospital, Capital Medical University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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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).
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Sham-komparator: 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).
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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).
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Difference in systolic blood pressure at end of treatment
Tidsramme: From baseline to week 4 (end of treatment)
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Comparison of the change from baseline in systolic blood pressure between the two treatment groups at the end of treatment (week 4)
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From baseline to week 4 (end of treatment)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Difference in systolic blood pressure at week 12
Tidsramme: From baseline to week 12
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Comparison of the change from baseline in diastolic blood pressure between the two groups at week 12
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From baseline to week 12
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Difference in diastolic blood pressure at the end of treatment
Tidsramme: From baseline to week 4 (end of treatment)
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Comparison of the change from baseline in diastolic blood pressure (DBP) between the two groups at the end of treatment (week 4)
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From baseline to week 4 (end of treatment)
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Difference in 24-hour ambulatory blood pressure parameter at the end of treatment: Mean 24-hour systolic blood pressure
Tidsramme: From baseline to week 4 (end of treatment)
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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)
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From baseline to week 4 (end of treatment)
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Difference in rate of achieving target blood pressure at the end of treatment
Tidsramme: From baseline to week 4 (end of treatment)
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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）
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From baseline to week 4 (end of treatment)
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Difference in proportion of achieving target blood pressure at week 12
Tidsramme: From baseline to week 12
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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
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From baseline to week 12
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. mai 2026
Primær fullføring (Antatt)
1. oktober 2027
Studiet fullført (Antatt)
1. mai 2028
Datoer for studieregistrering
Først innsendt
16. april 2026
Først innsendt som oppfylte QC-kriteriene
29. april 2026
Først lagt ut (Faktiske)
5. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Hi-tACS for HBP
- HZ2025PYLJ003 (Annet stipend/finansieringsnummer: Xuanwu Hospital, Capital Medical University)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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Nei
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