Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT05963958
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2023-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HD-Tdcs and Pharmacological Intervention For Delirium In Critical Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D016638', 'term': 'Critical Illness'}], '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': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Applicators were blinded to who was receiving active stimulation and who was receiving placebo. The study drug was prepared by the nurses or nursing technicians, or an otherwise uninvolved research associate so that investigators and clinicians were fully masked to allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2023-07-01', 'studyFirstSubmitQcDate': '2023-07-25', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delirium Severity', 'timeFrame': '28 days', 'description': 'delirium severity over the 28-day study period is measured using the CAM-ICU-7. Patients discharged before 28 days were considered without delirium.'}], 'secondaryOutcomes': [{'measure': 'length of stay in the ICU and hospital stay', 'timeFrame': '28 days', 'description': 'defined as the total number of days that patients remained in the hospital from the date of randomization to the date of hospital discharge'}, {'measure': 'Occurrence of hypotension requiring any vasopressor administration', 'timeFrame': '28 days'}, {'measure': 'C-reactive protein levels', 'timeFrame': '28 days'}, {'measure': 'ventilator-free days during the first 28 days', 'timeFrame': '28 days', 'description': 'defined as the number of days free from mechanical ventilation for at least 48 consecutive hours'}, {'measure': 'Exploratory analisys', 'timeFrame': '28 days', 'description': 'Organ dysfunction and clinical response; use of Concomitant Medications; Richmond Agitation Sedation Scale (RASS) and mortality prognosis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'Delirium', 'Critical Illness']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial Is conducted to evaluate the efficacy and safety of active or sham HD-tDCS in combination with dexmedetomidine in patients with moderate to severe ARDS due to COVID-19 with delirium in intensive care unit (ICU). The hypothesis was that HD-tDCS combined with concomitant dexmedetomidine would reduce delirium rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years,\n* confirmed clinical diagnosis for SARS-CoV-2,\n* delirium confirmed through the CAM-ICU-7 test, applied by trained evaluators\n\nExclusion Criteria:\n\n* severe psychiatric illness that is not well controlled;\n* pregnancy or active lactation,\n* refusal of consent\n* contraindications for brain stimulation such as: aneurysm clips, pacemaker, epilepsy, dermatitis at the site of stimulation'}, 'identificationModule': {'nctId': 'NCT05963958', 'acronym': 'COVID-19', 'briefTitle': 'HD-Tdcs and Pharmacological Intervention For Delirium In Critical Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Paraíba'}, 'officialTitle': 'HD-Tdcs Associated With The Use Of Dexmedetomidine For Delirium In Critical Patients With Covid-19', 'orgStudyIdInfo': {'id': 'Delirium/HD-tDCS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active HD-tDCS', 'description': 'HD-tDCS is delivered on 10 consecutive weekdays, with two sessions per day (in the morning and in the afternoon). For each participant, a 3-mA current is applied via a center anode. The electric current was supplied to the active group and presented an acceleration time of 30 s, maintained at 3 mA for 30 min and then reduced for 30 s. And a maintenance dosage of dexmedetomidine (0.2 - 0.7 mcg/kg per hour).', 'interventionNames': ['Combination Product: Active HD-tDCS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham HD-tDCS', 'description': 'HD-tDCS is delivered on 10 consecutive weekdays, with two sessions per day (in the morning and in the afternoon). For the simulated condition, the investigators maintained the same 30-second acceleration up to a total of 3 mA, followed immediately by a 30-second deceleration. And a maintenance dosage of dexmedetomidine (0.2 - 0.7 mcg/kg per hour).', 'interventionNames': ['Combination Product: Sham HD-tDCS']}], 'interventions': [{'name': 'Active HD-tDCS', 'type': 'COMBINATION_PRODUCT', 'description': 'Brain stimulation using active high definition transcranial direct current stimulation is applied simultaneously with the use of dexmedetomidine as a pharmacological treatment for delirium in critical illness patients with covid-19', 'armGroupLabels': ['Active HD-tDCS']}, {'name': 'Sham HD-tDCS', 'type': 'COMBINATION_PRODUCT', 'description': 'Sham high definition transcranial direct current stimulation is applied simultaneously with the use of dexmedetomidine as a pharmacological treatment for delirium in critical illness patients with covid-19', 'armGroupLabels': ['Sham HD-tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51051900', 'city': 'João Pessoa', 'state': 'Paraíba', 'country': 'Brazil', 'facility': 'Federal University of Paraiba', 'geoPoint': {'lat': -7.115, 'lon': -34.86306}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suellen Andrade', 'class': 'OTHER'}, 'collaborators': [{'name': 'City University of New York', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Suellen Andrade', 'investigatorAffiliation': 'Federal University of Paraíba'}}}}