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

29. april 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina
        • Xuanwu Hospital, Capital Medical University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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).
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).
Enhed: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference in systolic blood pressure at end of treatment
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference in systolic blood pressure at week 12
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Xuanwu Hospital, Beijing

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. oktober 2027

Studieafslutning (Anslået)

1. maj 2028

Datoer for studieregistrering

Først indsendt

16. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Hi-tACS for HBP
  • HZ2025PYLJ003 (Andet bevillings-/finansieringsnummer: Xuanwu Hospital, Capital Medical University)

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Kliniske forsøg med Primær hypertension

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

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