Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT05670418
Status:
UNKNOWN
Last Update Posted:
2023-11-18
First Post:
2022-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Function Analysis and qEEG Study in Long COVID-19 Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'id': 'D000086382', 'term': 'COVID-19'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-17', 'studyFirstSubmitDate': '2022-11-22', 'studyFirstSubmitQcDate': '2023-01-01', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Function', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Cognitive Function will be assessed using the qEEG, with an abnormality of brain wave activity, it indicates impairment of cognitive function'}], 'secondaryOutcomes': [{'measure': 'Cognitive quality Assessed by MOCA', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Severe score: ≤10 Moderate score: 10-17 Mild score: 18-25 Normal score: 26-30'}, {'measure': 'Self Rating Questionnaire (SRQ)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Lowest score: 0 Highest score: 20. Higher score indicates better health status.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Long COVID-19 Syndrome', 'COVID-19', 'Quantitative electroencephalography', 'Case-control study'], 'conditions': ['Long COVID-19 Syndrome']}, 'descriptionModule': {'briefSummary': 'Over than 30% individuals with COVID-19, including the asymptomatic ones, and around 80% of patients hospitalized with COVID-19 may experience post-COVID sequelae, which is commonly referred to as Long COVID Syndrome. This condition has ties to decreased cognitive function and may lead to neuropsychiatric disorders but still need to be studied further. Using a cross-sectional design, this study will analyze the relationship between cognitive function and neuropsychiatric disorders with brain wave activity in Long COVID patients.\n\nThe investigators conducted assessments utilizing the quantitative electroencephalogram (qEEG) measurement method and interviews using instruments such as the MOCA questionnaire and Self Rating Questionnaire (SRQ). With this qEEG examination, the investigators hoped that there will be an imbalance/abnormality of brain wave activity that arises related to impaired cognitive function.', 'detailedDescription': 'This study is aimed to analyze the cognitive function and neuropsychiatry disorders with brain wave activity using qEEG that occurs after COVID/Long Covid Syndrome.\n\nThe whole procedure will run for approximately 12 weeks based on the long COVID range.\n\nThe determinants of long COVID patients include: never been vaccinated, old age, comorbid, female population, and hospitalized patients.\n\nThe total number of subjects with the post-COVID syndrome in the proportion test is 30 subjects.\n\nThe measuring instruments used to measure the decline in cognitive function are the MOCA questionnaire and Self Rating Questionnaire (SRQ).\n\nThe target population is post-COVID-19 patients with Long COVID Syndrome.\n\nThe accessible population is post-COVID-19 patients who have been treated at RSCM Kiara and have regular checkups at the RSCM polyclinic with Long COVID Syndrome for 12 weeks or more.\n\nThe control population is post-COVID-19 patients who managed to recover without symptoms.\n\nThe Long COVID Syndrome patients who meet the inclusion criteria and have signed the consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COVID-19 Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Post-COVID-19 patients with Long COVID-19 Syndrome\n2. Over 18 years old\n3. Willing to participate in the research\n4. Completed the Montreal Cognitive Assessment (MoCA) and Self Rating Questionnaire (SRQ)\n\nExclusion Criteria:\n\n1\\. Patients with neuropsychiatric disorders before being infected with COVID-19'}, 'identificationModule': {'nctId': 'NCT05670418', 'briefTitle': 'Cognitive Function Analysis and qEEG Study in Long COVID-19 Syndrome Patients', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Cognitive Function Analysis and qEEG Study in Long COVID-19 Syndrome Patients', 'orgStudyIdInfo': {'id': '22-05-0578'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Long COVID-19', 'description': 'Patients post-COVID-19 with Long COVID-19 Syndrome', 'interventionNames': ['Device: Quantitative Electroencephalography']}, {'label': 'COVID-19', 'description': 'Patients post-COVID-19 without Long COVID-19 Syndrome', 'interventionNames': ['Device: Quantitative Electroencephalography']}], 'interventions': [{'name': 'Quantitative Electroencephalography', 'type': 'DEVICE', 'description': 'Each qEEG examination of one person lasted about 20 minutes and included two stages: the first-recording of brain waves with eyes closed (5 min), the other with eyes open (5 min)', 'armGroupLabels': ['COVID-19', 'Long COVID-19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Yetty Ramli, MD', 'role': 'CONTACT', 'email': 'yettyramli@gmail.com', 'phone': '+62811163843'}, {'name': 'Yetty Ramli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rumah Sakit Cipto Manunkusumo', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'centralContacts': [{'name': 'Yetty Ramli, MD', 'role': 'CONTACT', 'email': 'yettyramli@gmail.com', 'phone': '+62811163843'}, {'name': 'Dyah Tunjungsari, MD', 'role': 'CONTACT', 'email': 'penelitian.neuroui@gmail.com', 'phone': '+628119884224'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Staff & Lecturer', 'investigatorFullName': 'Dr. dr Yetty Ramli SpS', 'investigatorAffiliation': 'Indonesia University'}}}}