Safety and Efficacy Evaluation of Non-invasive Temporal Interference Stimulation for Blood Pressu… (NCT07577323) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Efficacy Evaluation of Non-invasive Temporal Interference Stimulation for Blood Pressure Modulation in Patients With Mild Essential Hypertension
China60 participantsStarted 2026-05-06
Plain-language 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.
Who can participate
Age range30 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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.
✓. Written informed consent has been obtained from the subject or their legally authorized representative after being informed of the potential risks.
Exclusion criteria
✕. Known or suspected secondary hypertension.
✕. 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).
✕. Subjects with high risk of cerebrovascular disease indicated by cranial magnetic resonance imaging.
✕. History of myocardial infarction or cerebral infarction.
✕. Atrial fibrillation or other severe arrhythmias, such as severe bradycardia, third-degree atrioventricular block, or ventricular tachycardia.
✕. 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).
What they're measuring
1
24-hour average systolic blood pressure (24h SBP)
Timeframe: Up to 12 weeks after temporal interference stimulation