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

NCT07577323 | Not Yet Recruiting

• 1 other identifier: 2026-128-001
• Study Type: interventional
• Target: 60
• 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 blood pressure modulation in patients with mild essential hypertension.

Conditions

Essential Hypertension

Keywords

essential hypertension; temporal interference stimulation; TI

Outcome Measures

Primary Outcomes (1)

• 24-hour average systolic blood pressure (24h SBP)

  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

Study Arms (2)

Temporal interference stimulation

EXPERIMENTAL

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

Sham temporal interference stimulation

SHAM COMPARATOR

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

Interventions

Temporal Interference DEVICE

The Non-invasive transcranial temporal interference stimulation will consist of 14 days of 20-min temporal interference stimulation.

Also known as: TI

Temporal interference stimulation

Sham Temporal Interference Stimulation DEVICE

The sham (inactive) temporal interference stimulation will consist of 5 days of 20-min temporal interference stimulation.

Also known as: sham TI

Sham temporal interference stimulation

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Atrial fibrillation or other severe arrhythmias, such as severe bradycardia, third-degree atrioventricular block, or ventricular tachycardia.
• 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).
• Females who are pregnant, breastfeeding, or planning to become pregnant within one year.
• Individuals unable to cooperate due to mental illness or other reasons.
• Participants enrolled in other clinical trials within 3 months prior to randomization.
• Participants deemed ineligible for this trial for other reasons determined by the investigator.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; 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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 11, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)