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

Efficacy and Safety Evaluation of Transcranial Non-invasive Temporal Interference Stimulation for Blood Pressure Regulation: A Pilot, Prospective Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Hypotension
• Intervention / Treatment: Other: Temporal Interference

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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liankun Ren, MD; Phone Number: +86 13681576621; Email: renlk2022@outlook.com

Study Locations

• China
  • Beijing, China
    • Xuanwu Hospital,Capital Medical University, Beijing, Beijing 100053
    • Contact: Liankun Ren, MD; Phone Number: +86 13681576621; Email: renlk2022@outlook.com
    • Principal Investigator: Liankun Ren, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Temporal interference stimulation; Patients with hypertension/hypotension assigned to temporal interference stimulation for 20 min per session.	Other: Temporal Interference; The intervention will consist of 5 days of 20-min temporal interference stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Liankun Ren, MD, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: November 15, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 15, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: hypertension; hypotension; temporal in terference
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Hypotension
• Other Study ID Numbers: 2025-220-002

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