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

NCT07239492 | Not Yet Recruiting DMC

• 1 other identifier: 2025-220-002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension; Hypotension

Keywords

hypertension; temporal in terference; hypotension

Outcome Measures

Primary Outcomes (1)

• Blood Pressure (BP24)

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

  Up to 12 weeks after temporal interference stimulation

Study Arms (1)

Temporal interference stimulation

EXPERIMENTAL

Patients with hypertension/hypotension assigned to temporal interference stimulation for 20 min per session.

Other: Temporal Interference

Interventions

Temporal Interference OTHER

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

Temporal interference stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65 years old, male or female;
• Three groups of patients will be enrolled in the study:
• 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;
• BMI: 18-30;
• After being informed of the potential risks, the patient agrees to participate in this study and signs the informed consent form (ICF).

You may not qualify if:

• 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;
• Those who have participated in other clinical studies within the past 3 months;
• Patients who apply to withdraw from this clinical study for any reason;
• Patients with cardiac insufficiency;
• Patients excluding those with white coat effect;
• Individuals with a high risk of cerebrovascular disease confirmed by transcranial magnetic resonance imaging (MRI).

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital,Capital Medical University, Beijing, Beijing 100053

Beijing, China

Location

MeSH Terms

Conditions

Hypertension; Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Liankun Ren, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liankun Ren, MD

CONTACT

+86 13681576621; renlk2022@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)