HypertensionNCT07239492
Efficacy and Safety Evaluation of Non-invasive Temporal Interference Stimulation for Blood Pressure Regulation
A study testing Temporal Interference in people with Hypertension and Hypotension, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The primary objective of this research is to study the efficacy and safety of temporal interference stimulation for regulating the blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Hypotension
- What is being tested?
- Temporal Interference
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital,Capital Medical University, Beijing, Beijing 100053
Beijing
Liankun Ren, MD, +86 13681576621, renlk2022@outlook.com
Liankun Ren, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Temporal Interference
- Keywords
- hypertension, temporal in terference, hypotension
- Medical subject headings
- Hypertension, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal InterferenceOther
The intervention will consist of 5 days of 20-min temporal interference stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Temporal interference stimulation | Experimental | Patients with hypertension/hypotension assigned to temporal interference stimulation for 20 min per session. Receives: Other: Temporal Interference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure (BP24)
Blood Pressure (BP24) is defined as 24-hour ambulatory blood pressure monitoring in each 4 weeks.
Measured: Up to 12 weeks after temporal interference stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liankun_Ren, Xuanwu Hospital, Beijing
- Investigators
- Liankun Ren, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239492
- Sponsor's protocol ID
- 2025-220-002
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Transcranial Non-invasive Temporal Interference Stimulation for Blood Pressure Regulation: A Pilot, Prospective Study
- ClinicalTrials.gov ID
- NCT07239492
- Acronym / sponsor ID
- 2025-220-002
- Conditions
- Hypertension, Hypotension
- Keywords
- hypertension, temporal in terference, hypotension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temporal interference stimulation | Experimental | Other: Temporal InterferencePatients with hypertension/hypotension assigned to temporal interference stimulation for 20 min per session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18-65 years old, male or female;
- Three groups of patients will be enrolled in the study:
- 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).
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporal InterferenceThe intervention will consist of 5 days of 20-min temporal interference stimulation. | Other | Temporal interference stimulation |
Primary outcome
Blood Pressure (BP24)
Time frame: Up to 12 weeks after temporal interference stimulation
Blood Pressure (BP24) is defined as 24-hour ambulatory blood pressure monitoring in each 4 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liankun Ren, MD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporal Interference in people with Hypertension and Hypotension, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liankun Ren, MD (+86 13681576621, renlk2022@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (BP24) (time frame: Up to 12 weeks after temporal interference stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.