Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-26 @ 11:38 AM
Study NCT ID:
NCT07239492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Evaluation of Non-invasive Temporal Interference Stimulation for Blood Pressure Regulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-15', 'studyFirstSubmitDate': '2025-11-15', 'studyFirstSubmitQcDate': '2025-11-15', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure (BP24)', 'timeFrame': 'Up to 12 weeks after temporal interference stimulation', 'description': 'Blood Pressure (BP24) is defined as 24-hour ambulatory blood pressure monitoring in each 4 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertension', 'temporal in terference', 'hypotension'], 'conditions': ['Hypertension', 'Hypotension']}, 'descriptionModule': {'briefSummary': 'The primary objective of this research is to study the efficacy and safety of temporal interference stimulation for regulating the blood pressure.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18-65 years old, male or female;\n2. Three groups of patients will be enrolled in the study:\n\n 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;\n 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;\n 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;\n3. BMI: 18-30;\n4. After being informed of the potential risks, the patient agrees to participate in this study and signs the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Patients with secondary hypertension;\n2. Patients with intracranial structural lesions (e.g., infarcts, vascular malformations, space-occupying lesions, etc.);\n3. Pregnant women;\n4. Individuals unable to cooperate due to mental illness or other reasons;\n5. Those who have participated in other clinical studies within the past 3 months;\n6. Patients who apply to withdraw from this clinical study for any reason;\n7. Patients with cardiac insufficiency;\n8. Patients excluding those with white coat effect;\n9. Individuals with a high risk of cerebrovascular disease confirmed by transcranial magnetic resonance imaging (MRI).'}, 'identificationModule': {'nctId': 'NCT07239492', 'briefTitle': 'Efficacy and Safety Evaluation of Non-invasive Temporal Interference Stimulation for Blood Pressure Regulation', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Efficacy and Safety Evaluation of Transcranial Non-invasive Temporal Interference Stimulation for Blood Pressure Regulation: A Pilot, Prospective Study', 'orgStudyIdInfo': {'id': '2025-220-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Temporal interference stimulation', 'description': 'Patients with hypertension/hypotension assigned to temporal interference stimulation for 20 min per session.', 'interventionNames': ['Other: Temporal Interference']}], 'interventions': [{'name': 'Temporal Interference', 'type': 'OTHER', 'description': 'The intervention will consist of 5 days of 20-min temporal interference stimulation.', 'armGroupLabels': ['Temporal interference stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Liankun Ren, MD', 'role': 'CONTACT', 'email': 'renlk2022@outlook.com', 'phone': '+86 13681576621'}, {'name': 'Liankun Ren, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Xuanwu Hospital,Capital Medical University, Beijing, Beijing 100053', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Liankun Ren, MD', 'role': 'CONTACT', 'email': 'renlk2022@outlook.com', 'phone': '+86 13681576621'}], 'overallOfficials': [{'name': 'Liankun Ren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xuanwu Hospital, Beijing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Liankun_Ren', 'investigatorAffiliation': 'Xuanwu Hospital, Beijing'}}}}