Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT06882733
Status:
RECRUITING
Last Update Posted:
2025-07-18
First Post:
2025-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Immediate Effect of Applying Transcutaneous Electrical Nerve Stimulation (TENS) on Sympathetic Ganglion and Gastrocnemius for Popliteal Blood Flow
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 43}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2025-03-12', 'studyFirstSubmitQcDate': '2025-03-17', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Doppler ultrasound measurement of changes in popliteal fossa blood flow', 'timeFrame': '45 minutes', 'description': 'Using Doppler ultrasound to measure blood flow before, during, immediately after, and 15 minutes after electrical stimulation to observe the effects of electrical stimulation on blood flow.'}], 'secondaryOutcomes': [{'measure': 'heart rate', 'timeFrame': '45 minutes', 'description': 'oximeter to measure heart rate before, during, immediately after, and 15 minutes after electrical stimulation to observe the effects of electrical stimulation on heart rate.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transcutaneous electrical nerve stimulation (TENS)', 'blood flow', 'sympathetic ganglia'], 'conditions': ['Transcutaneous Electrical Nerve Stimulation (TENS)', 'Popliteal', 'Blood Flow', 'Sympathetic Ganglia']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the immediate hemodynamic effects of transcutaneous electrical nerve stimulation (TENS) on the popliteal artery and vein. Vascular issues like PAOD and DVT are common in patients with diabetes, obesity, or immobility due to increased resistance and reduced blood flow. Traditional treatments (medication or surgery) are not always feasible, prompting interest in TENS as an alternative. Although primarily used for pain relief, TENS may enhance blood flow. This research compares different stimulation frequencies (80 Hz vs. 4 Hz) and sites (gastrocnemius muscle vs. thoracolumbar sympathetic ganglia) to identify the most effective configuration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy people\n2. Age: 18 years and above (inclusive)\n3. Body mass index (BMI) between 18.5 and 24\n\nExclusion Criteria:\n\n1. Unable to complete two interventions within a week\n2. Have contraindications to electrotherapy (for example: metal implants in the body, open wounds, pregnancy, sensory loss)\n3. Obvious varicose veins 4. Unable to lie down for about 1 to 2 hours 5. Taking drugs or nutritional supplements that affect autonomic nervous activity or vasodilation (for example: Ginkgo biloba) 6. Smoking 7. Ankle and Ankle Index (ABI) less than 0.9 or greater than 1.3'}, 'identificationModule': {'nctId': 'NCT06882733', 'acronym': 'TENS', 'briefTitle': 'The Immediate Effect of Applying Transcutaneous Electrical Nerve Stimulation (TENS) on Sympathetic Ganglion and Gastrocnemius for Popliteal Blood Flow', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University'}, 'officialTitle': 'The Immediate Effect of Applying Transcutaneous Electrical Nerve Stimulation (TENS) on Sympathetic Ganglion and Gastrocnemius for Popliteal Blood Flow', 'orgStudyIdInfo': {'id': 'KMUHIRB-E(I)-20240357'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sympathetic Ganglia with Low-Frequency Electrical Stimulation', 'description': 'Sympathetic Ganglia (T12.L1.L2) Low-Frequency Electrical Stimulation (4Hz) electrical stimulation:15-minute', 'interventionNames': ['Device: Transcutaneous Electrical Nerve Stimulation，TENS']}, {'type': 'EXPERIMENTAL', 'label': 'Sympathetic Ganglia with High-Frequency Electrical Stimulation', 'description': 'Sympathetic Ganglia (T12.L1.L2) Low-Frequency Electrical Stimulation (80Hz) electrical stimulation:15-minute', 'interventionNames': ['Device: Transcutaneous Electrical Nerve Stimulation，TENS']}, {'type': 'EXPERIMENTAL', 'label': 'gastrocnemius with Low-Frequency Electrical Stimulation', 'description': 'gastrocnemius with Low-Frequency Electrical Stimulation Low-Frequency (4Hz) electrical stimulation:15-minute', 'interventionNames': ['Device: Transcutaneous Electrical Nerve Stimulation，TENS']}, {'type': 'EXPERIMENTAL', 'label': 'gastrocnemius with high-Frequency Electrical Stimulation', 'description': 'gastrocnemius with high-Frequency Electrical Stimulation high-Frequency(80Hz) electrical stimulation:15-minute', 'interventionNames': ['Device: Transcutaneous Electrical Nerve Stimulation，TENS']}], 'interventions': [{'name': 'Transcutaneous Electrical Nerve Stimulation，TENS', 'type': 'DEVICE', 'description': 'low frequency (4Hz) and sympathetic ganglion(T12.L1.L2) low frequency (4Hz) and gastrocnemius high frequency (80Hz) and sympathetic ganglion(T12.L1.L2) high frequency (80Hz) and gastrocnemius', 'armGroupLabels': ['Sympathetic Ganglia with High-Frequency Electrical Stimulation', 'Sympathetic Ganglia with Low-Frequency Electrical Stimulation', 'gastrocnemius with Low-Frequency Electrical Stimulation', 'gastrocnemius with high-Frequency Electrical Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807378', 'city': 'Kaohsiung City', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'jie meng shen, graduate student', 'role': 'CONTACT', 'email': 'mengjie910419@gmail.com', 'phone': '+886-935751158'}], 'facility': 'Kaohsiung Medical University'}], 'centralContacts': [{'name': 'Mengjie Shen', 'role': 'CONTACT', 'email': 'mengjie910419@gmail.com', 'phone': '+886935751158'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'graduate student', 'investigatorFullName': 'Mengjie Shen', 'investigatorAffiliation': 'Kaohsiung Medical University'}}}}