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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorXuanwu Hospital, Beijing

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Temporal Interference
  • Sham Temporal Interference Stimulation

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators