Efficacy and Safety Evaluation of Non-invasive Temporal Interference Stimulation for Blood Pressure Regulation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXuanwu Hospital, Beijing

About this trial

The primary objective of this research is to study the efficacy and safety of temporal interference stimulation for regulating the blood pressure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18-65 years old, male or female;

Essential Hypertension Grade 1 (Low Risk) - Antihypertensive Medication-Naive Group: No other cardiovascular risk factors or disease history, with systolic blood pressure (SBP) ≥140 mmHg and <160 mmHg and/or diastolic blood pressure (DBP) ≥90 mmHg and <100 mmHg;

Essential Hypertension - Refractory Hypertension Group: Meeting one of the following conditions after intensive lifestyle intervention plus taking 3 different types of antihypertensive drugs (including thiazide diuretics) for ≥4 weeks, with each drug at the maximum dose or maximum tolerated dose: Clinic blood pressure ≥140/90 mmHg and 24-hour average ambulatory blood pressure ≥130/80 mmHg, or average home blood pressure ≥135/85 mmHg; or blood pressure can only be controlled below 140/90 mmHg with ≥4 types of antihypertensive drugs;

Neurogenic Orthostatic Hypotension (nOH) Group: A decrease in SBP ≥20 mmHg and/or DBP ≥10 mmHg within 3 minutes of the head-up tilt test (HUTT) and/or standing activity;

Disqualifiers

Patients with secondary hypertension;

Patients with intracranial structural lesions (e.g., infarcts, vascular malformations, space-occupying lesions, etc.);

Pregnant women;

Individuals unable to cooperate due to mental illness or other reasons;

Trial design

Design model

Single group

Treatments tested in this trial

  • Temporal Interference

    Other intervention

    The intervention will consist of 5 days of 20-min temporal interference stimulation.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Temporal interference stimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Blood Pressure (BP24)

Blood Pressure (BP24) is defined as 24-hour ambulatory blood pressure monitoring in each 4 weeks.

Time frame
Up to 12 weeks after temporal interference stimulation

Secondary outcomes

Other outcomes

Sponsors and contacts

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