Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-03 @ 6:05 PM
Study NCT ID:
NCT06517706
Status:
RECRUITING
Last Update Posted:
2024-12-06
First Post:
2024-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Research and Integrative Neuroscience Network for COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Participants will be randomly assigned to the experimental and control group. Both groups will receive cognitive rehabilitation. The experimental group control group will also active tDCS treatment whereas the control will receive inactive or sham tDCS treatment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Random Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2024-07-19', 'studyFirstSubmitQcDate': '2024-07-23', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cognitron Cognitive Assessment Battery', 'timeFrame': 'Pre & Post Testing, after completion of training at 6 weeks', 'description': 'Tests of memory, reaction time, and executive Functioning'}, {'measure': 'fNIRS', 'timeFrame': 'pre and post training testing, after completion of training at 6 weeks', 'description': 'Functional spectroscopy of oxygenated and deoxygenated hemodynamic responses'}], 'primaryOutcomes': [{'measure': 'Categorization Program Test 1', 'timeFrame': 'Administered pre & post training with the Categorization Program, at 6 weeks', 'description': 'Semantic knowledge and classification behavior'}, {'measure': 'Categorization Program Test 2', 'timeFrame': 'Administered pre & post training with the Categorization Program, at 6 weeks', 'description': 'Decision-Making and Rule based learning'}, {'measure': 'Probe Tasks', 'timeFrame': 'Administered pre testing, at 2 weeks, 3 weeks and after completion of training at 6 weeks', 'description': 'Decision-Making and Rule based learning'}, {'measure': 'WHO BREF Quality of Life', 'timeFrame': 'before and after training, at 6 weeks', 'description': 'general quality of life'}, {'measure': 'Dysexecutive Questionnaire', 'timeFrame': 'pre and post training, at 6 weeks', 'description': 'Test of everyday executive functioning behaviors; self and informant reports'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Training', 'Transcranial Direct Current Stimulation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://ucy.ac.cy/brainn', 'label': 'Project website'}]}, 'descriptionModule': {'briefSummary': 'The aim of the experimental study is to investigate two interventions for the management of cognitive symptoms resulting from long COVID. Participants will be randomly assigned into two interventions. 1. Categorization Program (CP) training with active tDCS or 2. Categorization Program training with sham tDCS.', 'detailedDescription': 'The two intervention protocols (digitalized CP and NIBS) required for this study have been developed and the required equipment (one existing and three new tDCS devices) has been acquired. Recruitment for the feasibility study is planned to begin in month 18, i.e., June 2024.\n\nChanges in the design of the feasibility study have been made by the SC and in coordination with the Advisory Board. The changes were deemed necessary to improve the original study design to capture changes in cognition due to treatment. Specifically, the feasibility study will retain the two-group design (experimental and control). Forty participants with PCS will be recruited (instead of seventy, as originally planned). All participants will undergo the diagnostic protocols (the neuroimaging and neuropsychological assessments). Then, participants will be randomly assigned into two groups: the experimental, who will receive the active tDCS and CP intervention, and the control group, who will receive the sham tDCS and CP intervention. Following the intervention, all participants (experimental and control) will complete a series of dependent measures, including neuropsychological performance and quality of life measures. For neurophysiological measures, electroencephalography (EEG) has been replaced with functional near-infrared spectroscopy (fNIRS), which will be conducted both pre- and post-intervention. The current design will require a longer intervention period (as compared to the original design) and the complete delivery of the digitalized CP to maximize treatment effectiveness.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Reported cognitive difficulties due to COVID-19 infection\n* WHO Long COVID criteria will be used\n\nExclusion Criteria:\n\n* Significant history of neuropsychiatric conditions prior to contracting COVID-19; history of neurological conditions such as TBI, CVA, MS prior to contracting COVID-19.'}, 'identificationModule': {'nctId': 'NCT06517706', 'acronym': 'BRAINN', 'briefTitle': 'Brain Research and Integrative Neuroscience Network for COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University of Cyprus'}, 'officialTitle': 'Brain Research and Integrative Neuroscience Network for COVID-19 (BRAINN)', 'orgStudyIdInfo': {'id': '101079001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control Condition', 'description': 'Combination of cognitive training with sham tDCS', 'interventionNames': ['Behavioral: Categorization Program']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Condition', 'description': 'Combination of cognitive training with active tDCS', 'interventionNames': ['Combination Product: Combination of tDCS (device) with cognitive training (behavioral)']}], 'interventions': [{'name': 'Combination of tDCS (device) with cognitive training (behavioral)', 'type': 'COMBINATION_PRODUCT', 'description': 'Participation in 15 one-hour sessions distributed over three weeks. During each session participants will receive two sessions of tDCS plus cognitive training with the Categorization Program', 'armGroupLabels': ['Experimental Condition']}, {'name': 'Categorization Program', 'type': 'BEHAVIORAL', 'description': 'Participation in 15 one-hour sessions distributed over three weeks. During each session participants will receive cognitive training and sham tDCS', 'armGroupLabels': ['Control Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1678', 'city': 'Nicosia', 'state': 'Cyprus', 'status': 'RECRUITING', 'country': 'Cyprus', 'contacts': [{'name': 'Fofi Constantinidou, Ph.D.', 'role': 'CONTACT', 'email': 'fofic@ucy.ac.cy', 'phone': '35722894437'}, {'name': 'Fofi Constantinidou, Ph.D.', 'role': 'CONTACT'}], 'facility': 'University of Cyprus', 'geoPoint': {'lat': 35.17284, 'lon': 33.35397}}], 'centralContacts': [{'name': 'Fofi Constantinidou, Ph.D.', 'role': 'CONTACT', 'email': 'fofic@ucy.ac.cy', 'phone': '+357 22892078'}, {'name': 'Eleni Michael', 'role': 'CONTACT', 'email': 'can@ucy.ac.cy', 'phone': '+35722895190'}], 'overallOfficials': [{'name': 'Fofi Constantinidou, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cyprus'}]}, 'ipdSharingStatementModule': {'url': 'https://www.ucy.ac.cy/brainn/', 'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'After data has been published, December 2026.', 'ipdSharing': 'YES', 'description': "Anonymized data will be entered in an open access depository as per funding agency's requirements. IPD that underlie results in a publication", 'accessCriteria': 'upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cyprus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychology', 'investigatorFullName': 'Fofi Constantinidou', 'investigatorAffiliation': 'University of Cyprus'}}}}