Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-01 @ 10:00 AM
Study NCT ID:
NCT04539704
Status:
COMPLETED
Last Update Posted:
2025-06-10
First Post:
2020-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Impacts of Static Magnetic Fields on Peripheral Pulses and Skin Blood Flow
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Subjects and coinvestigators making measurements are blinded to which devices are the active magnets and which are the sham magnets. Only the PI will have that information.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2020-08-31', 'studyFirstSubmitQcDate': '2020-08-31', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of magnet on skin blood flow', 'timeFrame': 'one hour', 'description': 'skin blood flow'}, {'measure': 'Effect of magnet on arterial pulses', 'timeFrame': 'one hour', 'description': 'Pulse values and paterns'}, {'measure': 'Characterization of temporal pattern of pulse changes and their amelioration', 'timeFrame': 'one hour', 'description': 'variability with and without normalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Arterial Stiffness', 'Magnetic Field Exposure', 'Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '33283550', 'type': 'DERIVED', 'citation': 'Mayrovitz HN, Astudillo A, Shams E. Finger skin blood perfusion during exposure of ulnar and median nerves to the static magnetic field of a rare-earth magnet: A randomized pilot study. Electromagn Biol Med. 2021 Jan 2;40(1):1-10. doi: 10.1080/15368378.2020.1856682. Epub 2020 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to investigate and determine the effects of static magnetic fields produced by a small magnet on peripheral pulses and skin blood flow.', 'detailedDescription': 'A specific neodymium magnet and sham device will be placed on certain sites near the ulnar and medial arteries and the effect of such placement on peripheral pulses assessed via PPG on fingers and on skin blood flow via laser Doppler perfusion determined. These assessments will be made while healthy subjects are lying supine on a padded examination table over a time interval of about 45-60 minutes. In addition to the impact that either the magnet or the sham devices have, the pulse and skin blood flow patterns and features will be analyzed from the point of view of sequential variability with and eye toward developing related parameters to potentially improve such variability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18-35 years\n2. No known neurological deficit\n3. No known cardiovascular condition\n\nExclusion Criteria:\n\n1. Unable or unwilling to lie reasonably still for about 55 minutes\n2. Known to have diabetes of any type\n3. Having any metallic or wire implant'}, 'identificationModule': {'nctId': 'NCT04539704', 'briefTitle': 'Assessing Impacts of Static Magnetic Fields on Peripheral Pulses and Skin Blood Flow', 'organization': {'class': 'OTHER', 'fullName': 'Nova Southeastern University'}, 'officialTitle': 'Assessing Impacts of Static Magnetic Fields on Peripheral Pulses and Skin Blood Flow', 'orgStudyIdInfo': {'id': '2019-598-NSU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Adults-magnet', 'description': 'Healthy adults with magnet and/or sham', 'interventionNames': ['Device: magnet and sham']}, {'type': 'SHAM_COMPARATOR', 'label': 'Healthy Adults-sham', 'description': 'Healthy adults with magnet and/or sham', 'interventionNames': ['Device: magnet and sham']}], 'interventions': [{'name': 'magnet and sham', 'type': 'DEVICE', 'description': 'In same subject some areas will have magnet and others will have sham', 'armGroupLabels': ['Healthy Adults-magnet', 'Healthy Adults-sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33328', 'city': 'Davie', 'state': 'Florida', 'country': 'United States', 'facility': 'Nova Southeastern University', 'geoPoint': {'lat': 26.06287, 'lon': -80.2331}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Southeastern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Harvey N. Mayrovitz, PhD', 'investigatorAffiliation': 'Nova Southeastern University'}}}}