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

29 april 2026 uppdaterad 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

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

50

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Enhet: 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 Comparator: 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).
Enhet: 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).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Difference in systolic blood pressure at end of treatment
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Difference in systolic blood pressure at week 12
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Xuanwu Hospital, Beijing

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 maj 2026

Primärt slutförande (Beräknad)

1 oktober 2027

Avslutad studie (Beräknad)

1 maj 2028

Studieregistreringsdatum

Först inskickad

16 april 2026

Först inskickad som uppfyllde QC-kriterierna

29 april 2026

Första postat (Faktisk)

5 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 april 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

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NEJ

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