Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT04895267
Status:
UNKNOWN
Last Update Posted:
2022-03-16
First Post:
2021-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low-field Thoracic Magnetic Stimulation Increases Peripheral Oxygen Saturation Levels in COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'The investigators designed a single-blind, sham-controlled, crossover study, in which the COVID-19 participants were blinded for the real LF-ThMS or sham stimulation conditions.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Arms:\n\nThe investigators designed a single-blind, sham-controlled, crossover study on COVID-19 participants who underwent two sessions of the study (real and sham Low-field thoracic magnetic stimulation, LF-ThMS), and other COVID-19 participants who underwent only the real LF-ThMS.\n\nSham comparator:\n\nFor sham exposure, the coils were positioned in the same coordinates in the same COVID-19 participants, but the LF-ThMS pulse generator was not turned on.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 17}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-09-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-14', 'studyFirstSubmitDate': '2021-05-15', 'studyFirstSubmitQcDate': '2021-05-15', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Change from Baseline Peripheral Oxygen Saturation levels (SpO2) during the intervention', 'timeFrame': '30 minutes', 'description': '1\\. Change from Baseline Peripheral Oxygen Saturation levels (SpO2) at 30 minutes of LF-ThMS intervention.'}, {'measure': '2. Peripheral Oxygen Saturation levels (SpO2) after the intervention', 'timeFrame': '6 months', 'description': '2\\. To evaluate the safety of the intervention, SpO2 levels also are evaluated up to 6 months after the 30 minutes single session of LF-ThMS intervention.'}], 'secondaryOutcomes': [{'measure': '1. Magnetic hyperthermia', 'timeFrame': '30 minutes', 'description': 'Coils temperature on the dorsal thorax is measured every 5 minutes during a 30 minutes LF-ThMS session (sham and real).'}, {'measure': '2. Frequency of the pulsed magnetic stimulation', 'timeFrame': '30 minutes', 'description': 'The frequency of the pulsed LF-ThMS on the dorsal thorax is measured every 5 minutes during a 30 minutes LF-ThMS session (sham and real).'}, {'measure': '3. Magnetic flux density of the pulsed magnetic stimulation', 'timeFrame': '30 minutes', 'description': 'The magnetic flux density of the pulsed LF-ThMS on the dorsal thorax is measured every 5 minutes during a 30 minutes LF-ThMS session (sham and real).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SpO2', 'low-field thoracic magnetic stimulation', 'SARS-CoV-2'], 'conditions': ['COVID-19', 'Acute Respiratory Failure', 'Oxygen Deficiency']}, 'referencesModule': {'references': [{'pmid': '34622862', 'type': 'DERIVED', 'citation': 'Dominguez-Nicolas SM, Manjarrez E. Low-field thoracic magnetic stimulation increases peripheral oxygen saturation levels in coronavirus disease (COVID-19) patients: A single-blind, sham-controlled, crossover study. Medicine (Baltimore). 2021 Oct 8;100(40):e27444. doi: 10.1097/MD.0000000000027444.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to present a proof-of-concept that a 30 minutes single-session of low-field thoracic magnetic stimulation (LF-ThMS) on the dorsal thorax can be employed to increase oxygen saturation (SpO2) levels in coronavirus disease (COVID-19) participants significantly. The investigators (Saul M. Dominguez-Nicolas and Elias Manjarrez) hypothesized that the variables associated with LF-ThMS, as hyperthermia, frequency, and magnetic flux density in the dorsal thorax, might be correlated to SpO2 levels in these participants. The investigators designed a single-blind, sham-controlled, crossover study on COVID-19 participants who underwent two sessions of the study (real and sham LF-ThMS), and other COVID-19 participants who underwent only the real LF-ThMS.', 'detailedDescription': 'The severe acute respiratory syndrome coronavirus (CoV)-2 (SARS-CoV-2) may cause low SpO2 and respiratory failure in COVID-19 patients. Hence the increase of SpO2 levels could be crucial for the quality of life and recovery of these patients. In this clinical trial, the investigators (Saul M. Dominguez-Nicolas and Elias Manjarrez) propose that an electromagnetic device termed low-field thoracic magnetic stimulation (LF-ThMS) system could be employed for 30 minutes to increase SpO2 levels in COVID-19 participants. This device non-invasively delivers a pulsed magnetic field from 100 to 118 Hz and 10.5 to 13.1 milliTesla (mT) (i.e., 105 to 131 Gauss) to the dorsal thorax. In line with preliminary studies, the scientific literature, and other devices currently used in musculoskeletal magnetic therapy, these frequencies and magnetic flux densities are safe for the participants. The investigators designed a single-blind, sham-controlled, crossover study on COVID-19 participants who underwent two sessions of the study (real and sham LF-ThMS) and other participants who underwent only the real LF-ThMS. The study design includes a 30 minutes single-session of LF-ThMS to avoid confounding factors related to the spontaneous recovery by natural immunity, common in many COVID-19 patients several days after the contagion. Here the LF-ThMS protocol is not intended to demonstrate its use as therapy but is instead designed to examine the following physiological hypothesis. The hypothesis that there is a statistically significant correlation between magnetic flux density, frequency, or temperature associated with the real LF-ThMS and SpO2 levels in COVID-19 participants. In this context, the present clinical trial is relevant because it could motivate future randomized clinical trials to examine whether the LF-ThMS could be helpful as a potential therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult participants diagnosed with mild to moderate COVID-19 disease without pneumonia.\n* COVID-19 participants with a SpO2 level less or equal to 90 %, exhibiting difficulty breathing, but not intubated.\n* COVID-19 participants with similar pharmacological treatment against COVID-19.\n* 20-85 years old\n\nExclusion Criteria:\n\n* COVID-19 patients with acute respiratory failure requiring urgent intubation\n* COVID-19 patients with impaired consciousness\n* Pregnant woman\n* Patients with metallic implants in the thorax, abdomen, or arms, or with electronic medical devices such as pacemakers\n* Children'}, 'identificationModule': {'nctId': 'NCT04895267', 'briefTitle': 'Low-field Thoracic Magnetic Stimulation Increases Peripheral Oxygen Saturation Levels in COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Univeristario Benemerita Universidad Autonoma de Puebla'}, 'officialTitle': 'Low-field Thoracic Magnetic Stimulation Increases Peripheral Oxygen Saturation Levels in Coronavirus Disease (COVID-19) Patients: a Single-blind, Sham-controlled, Crossover Study', 'orgStudyIdInfo': {'id': 'Registration number: 818'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Real Low-field thoracic magnetic stimulation (LF-ThMS)', 'description': 'Crossover, single-blind session of low field thoracic magnetic stimulation (real LF-ThMS)', 'interventionNames': ['Device: Low-field thoracic magnetic stimulation (LF-ThMS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Low-field thoracic magnetic stimulation (LF-ThMS)', 'description': 'In the same patients the coils are positioned in the same coordinates for sham exposure, but the pulse generator is not turned on. Subjects are blinded for the real LF-ThMS or sham stimulation conditions.', 'interventionNames': ['Device: Low-field thoracic magnetic stimulation (LF-ThMS)']}], 'interventions': [{'name': 'Low-field thoracic magnetic stimulation (LF-ThMS)', 'type': 'DEVICE', 'description': 'A 30 minutes session of low-field thoracic magnetic stimulation (LF-ThMS) is planned for each participant.', 'armGroupLabels': ['Real Low-field thoracic magnetic stimulation (LF-ThMS)', 'Sham Low-field thoracic magnetic stimulation (LF-ThMS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72570', 'city': 'Puebla City', 'country': 'Mexico', 'facility': 'Benemérita Universidad Autónoma de Puebla', 'geoPoint': {'lat': 19.04778, 'lon': -98.20723}}], 'overallOfficials': [{'name': 'Elias Manjarrez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benemérita Universidad Autónoma de Puebla'}, {'name': 'Saul M Dominguez-Nicolas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Veracruzana'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Starting 6 months after publication', 'ipdSharing': 'YES', 'description': 'The investigators (Saul M. Dominguez-Nicolas and Elias Manjarrez) plan to make individual participant data (IPD) collected in this study.', 'accessCriteria': 'open access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elias Manjarrez', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Council of Science and Technology, Mexico', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Profesor Investigador Titular', 'investigatorFullName': 'Elias Manjarrez', 'investigatorAffiliation': 'Hospital Univeristario Benemerita Universidad Autonoma de Puebla'}}}}