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

NCT ID: NCT07239492

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-01-01

Brief Summary

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

Detailed Description

This project aims to include 25 participants, and evaluate the effectiveness and safety of temporal interference stimulation in patients with hypertension and hypotension through A pilot, prospective clinical trial. It is expected to provide new therapeutic options for patients with hypertension and hypotension with alternative treatment options.

Conditions

Hypertension; Hypotension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Temporal interference stimulation

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

Group Type: EXPERIMENTAL

Temporal Interference

Intervention Type: OTHER

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

Interventions

Temporal Interference

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

2. Three groups of patients will be enrolled in the study:

1. 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;

2. 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;

3. 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;

3. BMI: 18-30;

4. After being informed of the potential risks, the patient agrees to participate in this study and signs the informed consent form (ICF).

Exclusion Criteria

1. Patients with secondary hypertension;

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

3. Pregnant women;

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

5. Those who have participated in other clinical studies within the past 3 months;

6. Patients who apply to withdraw from this clinical study for any reason;

7. Patients with cardiac insufficiency;

8. Patients excluding those with white coat effect;

9. Individuals with a high risk of cerebrovascular disease confirmed by transcranial magnetic resonance imaging (MRI).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Liankun_Ren

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liankun Ren, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital,Capital Medical University, Beijing, Beijing 100053

Beijing, , China

Countries

China

Central Contacts

Liankun Ren, MD

Role: CONTACT

renlk2022@outlook.com

+86 13681576621

Facility Contacts

Liankun Ren, MD

Role: primary

renlk2022@outlook.com

+86 13681576621

Other Identifiers

2025-220-002

Identifier Type: -

Identifier Source: org_study_id