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

May 4, 2026 updated by: Liankun_Ren, Xuanwu Hospital, Beijing

Safety and Efficacy Evaluation of Non-invasive Temporal Interference Stimulation for Blood Pressure Modulation in Patients With Mild Essential Hypertension: A Prospective, Double-blind, Randomized Controlled 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This project aims to include 60 participants, who are randomly assigned in a 1 ratio into two groups named TI group and sham TI group , and evaluate the effectiveness and safety of temporal interference stimulation in patients with mild essential hypertension and through A prospective, double-blind, randomized controlled clinical trial. It is expected to provide new therapeutic options for patients with mild essential hypertension with alternative treatment options.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100053
        • Xuanwu Hospital,Capital Medical University
        • Contact:
          • Liankun Ren, MD
          • Phone Number: +86 13681576621

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged between 30 and 65 years old.
  2. Office blood pressure with systolic blood pressure (SBP) 140-159 mmHg and/or diastolic blood pressure (DBP) 90-99 mmHg.
  3. 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.
  4. Written informed consent has been obtained from the subject or their legally authorized representative after being informed of the potential risks.

Exclusion Criteria:

  1. Known or suspected secondary hypertension.
  2. 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).
  3. Subjects with high risk of cerebrovascular disease indicated by cranial magnetic resonance imaging.
  4. History of myocardial infarction or cerebral infarction.
  5. Atrial fibrillation or other severe arrhythmias, such as severe bradycardia, third-degree atrioventricular block, or ventricular tachycardia.
  6. Severe or unstable medical conditions, including severe hepatic dysfunction (defined as alanine transaminase or aspartate transaminase level more than 2 times the upper limit of normal), severe renal dysfunction (defined as serum creatinine level more than 1.5 times the upper limit of normal), and severe heart failure (New York Heart Association Class III and IV).
  7. Females who are pregnant, breastfeeding, or planning to become pregnant within one year.
  8. Individuals unable to cooperate due to mental illness or other reasons.
  9. Participants enrolled in other clinical trials within 3 months prior to randomization.
  10. Participants deemed ineligible for this trial for other reasons determined by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Temporal interference stimulation
Non-invasive temporal interference stimulation targeting the left subgenual anterior cingulate cortex (sgACC). Parameters: 2000 Hz carrier frequency, 1 Hz envelope frequency, 4 mA intensity, 20 minutes per session, administered once daily for 14 consecutive days.
Device: Temporal Interference
The Non-invasive transcranial temporal interference stimulation will consist of 14 days of 20-min temporal interference stimulation.
Other Names:
  • TI
Sham Comparator: Sham temporal interference stimulation
Sham stimulation with no envelope frequency. All other parameters (carrier frequency, intensity, duration, electrode placement) are identical to the active stimulation. Double-blind design.
Device: Sham Temporal Interference Stimulation
The sham (inactive) temporal interference stimulation will consist of 5 days of 20-min temporal interference stimulation.
Other Names:
  • sham TI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
24-hour average systolic blood pressure (24h SBP)
Time Frame: Up to 12 weeks after temporal interference stimulation
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.
Up to 12 weeks after temporal interference stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuanwu Hospital, Beijing

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Liankun Ren, MD, Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-128-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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