Essential HypertensionNCT07577323
Safety and Efficacy Evaluation of Non-invasive Temporal Interference Stimulation for Blood Pressure Modulation in Patients With Mild Essential Hypertension
A study testing Temporal Interference in people with Essential Hypertension, 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 blood pressure modulation in patients with mild essential hypertension. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Temporal Interference
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2026to 31 Dec 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
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 Municipality, 100053
Liankun Ren, MD, +86 13681576621
About this study
Official title: 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.
Read the 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.
- Conditions
- Essential Hypertension
- Being tested
- Temporal Interference, Sham Temporal Interference Stimulation
- Keywords
- essential hypertension, temporal interference stimulation, TI
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal InterferenceDevice
Also called TI
The Non-invasive transcranial temporal interference stimulation will consist of 14 days of 20-min temporal interference stimulation.
Sham Temporal Interference StimulationDevice
Also called sham TI
The sham (inactive) temporal interference stimulation will consist of 5 days of 20-min temporal interference stimulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Temporal Interference Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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 posted11 May 2026
- Study start6 May 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT07577323
- Sponsor's protocol ID
- 2026-128-001
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07577323
- Acronym / sponsor ID
- 2026-128-001
- Conditions
- Essential Hypertension
- Keywords
- essential hypertension, temporal interference stimulation, TI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 6 May 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 May 2026 (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 blood pressure modulation in patients with mild essential hypertension.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temporal interference stimulation | Experimental | Device: Temporal InterferenceNon-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. |
| Sham temporal interference stimulation | Sham comparator | Device: Sham Temporal Interference StimulationSham stimulation with no envelope frequency. All other parameters (carrier frequency, intensity, duration, electrode placement) are identical to the active stimulation. Double-blind design. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 InterferenceAlso: TIThe Non-invasive transcranial temporal interference stimulation will consist of 14 days of 20-min temporal interference stimulation. | Device | Temporal interference stimulation |
| Sham Temporal Interference StimulationAlso: sham TIThe sham (inactive) temporal interference stimulation will consist of 5 days of 20-min temporal interference stimulation. | Device | Sham temporal interference stimulation |
Primary outcome
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.
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 11 May 2026.
- 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 Essential Hypertension, 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 4 inclusion and 10 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 11 May 2026. 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. Some participants in this study may receive a placebo. 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?
24-hour average systolic blood pressure (24h SBP) (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 11 May 2026.