Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-26 @ 5:23 AM
Study NCT ID:
NCT05198466
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2022-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Electrical Stimulation for Critically Ill Post-Covid-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D018908', 'term': 'Muscle Weakness'}], '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': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004558', 'term': 'Electric Stimulation'}], 'ancestors': [{'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bijan.najafi@bcm.edu', 'phone': '7137987536', 'title': 'Bijan Najafi', 'organization': 'Baylor College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 month', 'eventGroups': [{'id': 'EG000', 'title': 'Active E-Stim', 'description': 'Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).\n\nElectrical Stimulation: Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Electrical Stimulation - Sham', 'description': 'Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).\n\nElectrical Stimulation - Sham: Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active E-Stim', 'description': 'Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).\n\nElectrical Stimulation: Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).'}, {'id': 'OG001', 'title': 'Electrical Stimulation - Sham', 'description': 'Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).\n\nElectrical Stimulation - Sham: Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).'}], 'classes': [{'categories': [{'measurements': [{'value': '363.04', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '359.55', 'spread': '2.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'an average of 4 weeks (Phase II)', 'description': 'Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).', 'unitOfMeasure': 'miliVolts', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ankle Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active E-Stim', 'description': 'Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).\n\nElectrical Stimulation: Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).'}, {'id': 'OG001', 'title': 'Electrical Stimulation - Sham', 'description': 'Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).\n\nElectrical Stimulation - Sham: Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '3.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'an average of 4 weeks (phase II).', 'description': 'Ankle strength will be measured in response to the average of three 5-second dorsiflexion maximum voluntary isometric contractions per 30 seconds of relaxation in-between using a dynamometer (RoMech Digital Hanging Scale).', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plantar Oxyhemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active E-Stim', 'description': 'Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).\n\nElectrical Stimulation: Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).'}, {'id': 'OG001', 'title': 'Electrical Stimulation - Sham', 'description': 'Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).\n\nElectrical Stimulation - Sham: Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).'}], 'classes': [{'categories': [{'measurements': [{'value': '.57', 'spread': '.07', 'groupId': 'OG000'}, {'value': '.54', 'spread': '.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'an average of 4 weeks (phase II)', 'description': 'Percentage of oxyhemoglobin (OxyHb) will be measured using a validated near-infrared (NIR) camera (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Can) that detects an approximate value of real-time OxyHb level in superficial tissue. The metatarsus area including the five toes will be traced. Data reported includes plantar oxyhemoglobin after 10 minutes of stopping 1 hour of electrical stimulation therapy.', 'unitOfMeasure': 'Percentage of oxyhemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active E-Stim', 'description': 'Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).\n\nElectrical Stimulation: Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).'}, {'id': 'FG001', 'title': 'Electrical Stimulation - Sham', 'description': 'Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).\n\nElectrical Stimulation - Sham: Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Please note that these results only include Post-Covid-19 Patients (Phase II).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active E-Stim', 'description': 'Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).\n\nElectrical Stimulation: Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).'}, {'id': 'BG001', 'title': 'Electrical Stimulation - Sham', 'description': 'Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).\n\nElectrical Stimulation - Sham: Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.10', 'spread': '9.86', 'groupId': 'BG000'}, {'value': '52.38', 'spread': '7.44', 'groupId': 'BG001'}, {'value': '51.74', 'spread': '8.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-19', 'size': 488604, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-21T15:15', 'hasProtocol': True}, {'date': '2022-12-19', 'size': 81358, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-12-21T15:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Devices may be active or sham.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to intervention (IG) or control group (CG) with ratio of 1:1. The entire cohort will receive daily electrical stimulation (EE) in lower extremity (e.g. Gastrocnemius muscle) for up to 1 hour. The EE device will be functional for IG and non-functional for CG.\n\nPhase II will include previously hospitalized patients (n=20) who had recover from severe COVID-19 infection, but present persistent neuromuscular sequelae. This will be performed in an outpatient clinic. The time frame will be 4 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2022-01-18', 'resultsFirstSubmitDate': '2022-12-21', 'studyFirstSubmitQcDate': '2022-01-18', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-21', 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation', 'timeFrame': 'an average of 4 weeks (Phase II)', 'description': 'Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).'}, {'measure': 'Ankle Strength', 'timeFrame': 'an average of 4 weeks (phase II).', 'description': 'Ankle strength will be measured in response to the average of three 5-second dorsiflexion maximum voluntary isometric contractions per 30 seconds of relaxation in-between using a dynamometer (RoMech Digital Hanging Scale).'}], 'secondaryOutcomes': [{'measure': 'Plantar Oxyhemoglobin', 'timeFrame': 'an average of 4 weeks (phase II)', 'description': 'Percentage of oxyhemoglobin (OxyHb) will be measured using a validated near-infrared (NIR) camera (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Can) that detects an approximate value of real-time OxyHb level in superficial tissue. The metatarsus area including the five toes will be traced. Data reported includes plantar oxyhemoglobin after 10 minutes of stopping 1 hour of electrical stimulation therapy.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Electrical Stimulation', 'Skin perfusion', 'Muscle dysfunction'], 'conditions': ['COVID-19', 'Muscle Atrophy', 'Muscle Weakness']}, 'referencesModule': {'references': [{'pmid': '36905161', 'type': 'DERIVED', 'citation': 'Zulbaran-Rojas A, Lee M, Bara RO, Flores-Camargo A, Spitz G, Finco MG, Bagheri AB, Modi D, Shaib F, Najafi B. Electrical stimulation to regain lower extremity muscle perfusion and endurance in patients with post-acute sequelae of SARS CoV-2: A randomized controlled trial. Physiol Rep. 2023 Mar;11(5):e15636. doi: 10.14814/phy2.15636.'}]}, 'descriptionModule': {'briefSummary': 'Unfortunately, hospital-acquired weakness is highly prevalent among COVID-19 hospitalized patients, who often require prolonged bed-rest or paralytics for an extended period of time in order to maintain oxygenation. Prolonged bed rest has been associated with pronounced loss of muscle mass that can exceed 10% over the 1st week, which leads to functional impairment and complications post-hospital discharge. Physical therapy and in-hospital mobility program may reduce the incident of hospital-acquired weakness, but they are often impractical for COVID-19 patients. In particular, conventional mobility programs are challenging for those who are being treated in an intensive Care Unit. The purpose of this study is to test feasibility and proof-of-concept effectiveness of daily use of lower extremity electrical stimulation (EE) therapy, as a practical solution to address lower extremity muscle deconditioning, to address chronic consequences of COVID-19 including hospital-acquired weakness.', 'detailedDescription': '20 subjects that were hospitalized due to severe COVID-19 infection and present neuromuscular complications (i.e., hospital acquired weakness due to neuromyopathy) will be recruited after the first phase of this study is completed. Unlike Phase I (study for prevention), this is a proof of concept randomized control trial (RCT) study for recovery. The patients will be recruited from the COVID-19 Clinic at Baylor College of Medicine and will begin the study after being diagnosed with neuromyopathy due to prolonged hospitalization for COVID-19. This will be performed by a critical care and pulmonary specialist at the BCM COVID-19 Clinic. The entire cohort will receive daily electrical stimulation in lower extremity (e.g. Gastrocnemius, tibial anterior muscle) up to 1 hour to recover from Neuromyopathy complications and prolonged hospital stay. Participants will be randomized to intervention (IG) or control group (CG)). EE therapy will be provided using a bio-electric stimulation technology (BEST) platform (Tennant Biomodulator PRO®, AVAZZIA, Inc.). The EE device will be functional for IG and non-functional for CG. In addition to taking the device home to deliver electrical stimulation themselves, the patients will attend a weekly assessment at the McNair Campus for up to 4 weeks. The primary outcomes include between group difference and change from the baseline in muscle endurance, muscle strength, lower extremity tissue oxygen saturation, neuropathy, and muscle atrophy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-COVID-19 patients who required hospitalization due to COVID-19 severe infection.\n* Post-COVID-19 patients who required hospitalization and present neuromuscular sequelae due to COVID-19 severe infection.\n\nExclusion Criteria:\n\n* Patient has a demand-type cardiac pacemaker, implanted defibrillator or other implanted electronic device.\n* Active wound infection.\n* Below the knee amputations.\n* Based on the clinicians decision whether the patient is eligible for the study.'}, 'identificationModule': {'nctId': 'NCT05198466', 'acronym': 'Phase II', 'briefTitle': 'Electrical Stimulation for Critically Ill Post-Covid-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Electrical Stimulation Therapy for Recovery of Hospital-acquired Weakness in Critically Ill COVID-19 Patients - A Proof of Concept Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H-47781-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active E-Stim', 'description': 'Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).', 'interventionNames': ['Device: Electrical Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Electrical Stimulation - Sham', 'description': 'Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).', 'interventionNames': ['Device: Electrical Stimulation - Sham']}], 'interventions': [{'name': 'Electrical Stimulation', 'type': 'DEVICE', 'description': 'Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).', 'armGroupLabels': ['Active E-Stim']}, {'name': 'Electrical Stimulation - Sham', 'type': 'DEVICE', 'description': 'Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).', 'armGroupLabels': ['Electrical Stimulation - Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Avazzia, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Bijan Najafi, PhD', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}