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.
Aged between 30 and 65 years old.
Office blood pressure with systolic blood pressure (SBP) 140-159 mmHg and/or diastolic blood pressure (DBP) 90-99 mmHg.
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.
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.
Parallel
Temporal Interference
DeviceThe Non-invasive transcranial temporal interference stimulation will consist of 14 days of 20-min temporal interference stimulation.
Sham Temporal Interference Stimulation
DeviceThe sham (inactive) temporal interference stimulation will consist of 5 days of 20-min temporal interference stimulation.
24-hour average systolic blood pressure (24h SBP)
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
