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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporal Interference | Device | The Non-invasive transcranial temporal interference stimulation will consist of 14 days of 20-min temporal interference stimulation. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liankun Ren, MD | Contact | +86 13681576621 | renlk2022@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Liankun Ren, MD | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital,Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
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| Sham Temporal Interference Stimulation | Device | The sham (inactive) temporal interference stimulation will consist of 5 days of 20-min temporal interference stimulation. |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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