Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT05753202
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
tDCS in Post-COVID Syndrome: Comparison of Two Targets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D003863', 'term': 'Depression'}], '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': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-28', 'studyFirstSubmitDate': '2023-03-01', 'studyFirstSubmitQcDate': '2023-03-01', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue Severity Scale (score)', 'timeFrame': '1 month', 'description': 'Physical fatigue'}], 'secondaryOutcomes': [{'measure': 'Modified Fatigue Impact Scale (MFIS) (score)', 'timeFrame': '1 month', 'description': 'Physical and cognitive fatigue'}, {'measure': 'FLEI scale (score)', 'timeFrame': '1 month', 'description': 'Subjective cognition.'}, {'measure': 'Beck Depression Inventory (2nd version) (score)', 'timeFrame': '1 month', 'description': 'Depressive symptoms'}, {'measure': 'Pittsburgh Sleep Quality Index (score)', 'timeFrame': '1 month', 'description': 'Sleep quality'}, {'measure': 'Brief Pain Inventory (score)', 'timeFrame': '1 month', 'description': 'Pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post-COVID syndrome', 'brain stimulation', 'fatigue', 'cognitive', 'depression', 'transcranial direct current stimulation', 'non-invasive brain stimulation'], 'conditions': ['COVID-19', 'Post-COVID-19 Syndrome', 'Post COVID-19 Condition']}, 'referencesModule': {'references': [{'pmid': '40702022', 'type': 'DERIVED', 'citation': 'Oliver-Mas S, Matias-Guiu JA, Delgado-Alonso C, Gil-Martinez L, Cuevas C, Polidura C, Fernandez-Romero L, Matias-Guiu A, Gomez-Ruiz N, Gil-Moreno MJ, Yus-Fuertes M, Matias-Guiu J, Diez-Cirarda M. A randomized comparative feasibility study of neuromodulation and cognitive training for post-COVID fatigue. Sci Rep. 2025 Jul 23;15(1):26818. doi: 10.1038/s41598-025-09772-8.'}]}, 'descriptionModule': {'briefSummary': 'The main aim of this study is to compare the effect of two non-invasive neuromodulation targets in patients meeting WHO criteria for the post-COVID condition. A randomized, parallel, double-blind study will be conducted. Patients will receive 15 neuromodulation sessions through transcranial electrical stimulation for 3 weeks, associated with cognitive stimulation during therapy. The main objective will be to evaluate the change in physical fatigue. As secondary objectives, changes in cognition, depression, pain, quality of sleep and quality of life will be evaluated. The objective of this study is to evaluate the effect of two targets (left dorsolateral prefrontal and M1) of the neuromodulation intervention, together with cognitive stimulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of COVID-19 at least 6 months before the participation in the study.\n* Diagnosis of post-COVID condition according to WHO criteria.\n* Age 18-65 years.\n* Spanish as native language.\n* Sign of written informed consent.\n\nExclusion Criteria:\n\n* History of stroke\n* History of traumatic brain injury or central nervous system infection\n* Diagnosis of other neurological or medical disorder that could impact on fatigue.\n* Diagnosis of active psychiatric disorder potentially impacting on fatigue or cognitive function.\n* Chemotherapy or radiotherapy for cancer.\n* Severe sensory deficits (e.g. visual loss) that could limit assessments included int the study protocol.\n* Taking drugs or uncontrolled medical disorder potentially causing or worsening fatigue. Specifically, uncontrolled adrenal insufficiency, miastenic syndromes, thyroid disorders, cardiac failure, chronic kidney disorders and neurodegenerative disorders are excluded.\n* History of abuse of alcohol or other toxics.\n* Any contraindication for transcranial electric stimulation: epilepsy, pregnancy, metallic implants, brain devices, pacemakers, head injuries).'}, 'identificationModule': {'nctId': 'NCT05753202', 'briefTitle': 'tDCS in Post-COVID Syndrome: Comparison of Two Targets', 'organization': {'class': 'OTHER', 'fullName': 'Hospital San Carlos, Madrid'}, 'officialTitle': 'Neuromodulation Using Transcranial Direct Current Stimulation (tDCS) in Post-COVID Syndrome: Comparison of Two Targets', 'orgStudyIdInfo': {'id': '22/728-P-EC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Left dorsolateral prefrontal cortex', 'description': '15 sessiones of anodal tDCS over the left dorsolateral prefrontal cortex (2 mA, 20 minutes) associated with cognitive training.', 'interventionNames': ['Device: transcranial current direct stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Left M1', 'description': '15 sessiones of anodal tDCS over the left M1 (2 mA, 20 minutes) associated with cognitive training.', 'interventionNames': ['Device: transcranial current direct stimulation']}], 'interventions': [{'name': 'transcranial current direct stimulation', 'type': 'DEVICE', 'description': 'Transcranial electrical stimulation over two different brain regions associated with cognitive training. 15 sesions in 3 weeks (5 days/week)', 'armGroupLabels': ['Left M1', 'Left dorsolateral prefrontal cortex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos.', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Jordi A Matias-Guiu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinico San Carlos'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'After the end of the study and publication of the results. For 5 years.', 'ipdSharing': 'YES', 'description': 'all IPD that underlie results in a publication', 'accessCriteria': 'Data will be shared after reasonable request to the principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital San Carlos, Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD MD', 'investigatorFullName': 'Jordi A Matias-Guiu', 'investigatorAffiliation': 'Hospital San Carlos, Madrid'}}}}