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Starting soon Not applicable

Safety and Efficacy Evaluation of Non-invasive Temporal Interference Stimulation for Blood Pressure Modulation in Patients With Mild Essential Hypertension

NCT07577323 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-05-06
Last updated
2026-05-11

Condition(s) studied

Essential Hypertension

Investigational drug(s) / intervention(s)

Temporal InterferenceSham Temporal Interference Stimulation

Temporal Interference: The Non-invasive transcranial temporal interference stimulation will consist of 14 days of 20-min temporal interference stimulation.

Sham Temporal Interference Stimulation: The sham (inactive) temporal interference stimulation will consist of 5 days of 20-min temporal interference stimulation.

Study summary

The primary objective of this research is to study the efficacy and safety of temporal interference stimulation for blood pressure modulation in patients with mild essential hypertension.

Eligibility

Sex
ALL
Min age
30 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Aged between 30 and 65 years old. 2. Office blood pressure with systolic blood pressure (SBP) 140-159 mmHg and/or diastolic blood pressure (DBP) 90-99 mmHg. 3. No intake of any antihypertensive drugs or have discontinued antihypertensive medication for at least 3 months prior to randomization; no intention to receive any other antihypertensive therapy within the 15-week study period. 4. Written informed consent has been obtained from the subject or their legally authorized representative after being informed of the potential risks. Exclusion Criteria: 1. Known or suspected secondary hypertension. 2. Contraindications to TI treatment or sham TI treatment, including intracranial metal implants (e.g., pacemaker, ventriculoperitoneal shunt, vascular clip), craniocerebral surgery within the last 6 months, history of intracranial tumor or hemorrhage; skin damage, infection, eczema or allergy at the stimulation site (frontal/temporal region); severe skin diseases (e.g., psoriasis). 3. Subjects with high risk of cerebrovascular disease indicated by cranial magnetic resonance imaging. 4. History of myocardial infarction or cerebral infarction. 5. Atrial fibrillation or other severe arrhythmias, such as severe bradycardia, third-degree atrioventricular block, or ventricular tachycardia. 6. Severe or unstable medical conditions, including severe hepatic dysfunction (defined as alanine transaminase or aspartate transaminase level more than 2 times the upper limit of normal), severe renal dysfunction (defined as serum creatinine level more than 1.5 times the upper limit of normal), and severe heart failure (New York Heart Association Class III and IV). 7. Females who are pregnant, breastfeeding, or planning to become pregnant within one year. 8. Individuals unable to cooperate due to mental illness or other reasons. 9. Participants enrolled in other clinical trials within 3 months prior to randomization. 10. Participants deemed ineligible for this trial for other reasons determined by the investigator.

Primary outcome measure(s)

  • 24-hour average systolic blood pressure (24h SBP) — Up to 12 weeks after temporal interference stimulation
    The primary efficacy outcome was the change in 24-hour average systolic BP assessed on the basis of ambulatory BP measurements from baseline to 2 weeks.

Trial sites (1)

FacilityCityRegionStatus
Xuanwu Hospital,Capital Medical University Beijing Beijing Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07577323 on ClinicalTrials.gov ↗ ← All trials in China