Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT06449794
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuropsycatric Disorders Among Children With Systemic Lupus Erythematosus in Sohag University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-07', 'studyFirstSubmitDate': '2024-06-04', 'studyFirstSubmitQcDate': '2024-06-04', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'detect the clinical spectrum of Neuropsycatric disorders in Children with SLE', 'timeFrame': '1 year', 'description': 'the diagnostic criteria of SLE (The European League Against Rheumatism and The American College of Rheumatology'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '23263866', 'type': 'BACKGROUND', 'citation': 'Kozora E, Erkan D, West SG, Filley CM, Zhang L, Ramon G, Duggan E, Lockshin MD. Site differences in mild cognitive dysfunction (MCD) among patients with systemic lupus erythematosus (SLE). Lupus. 2013 Jan;22(1):73-80. doi: 10.1177/0961203312468963.'}, {'pmid': '25638807', 'type': 'BACKGROUND', 'citation': 'Pamfil C, Fanouriakis A, Damian L, Rinzis M, Sidiropoulos P, Tsivgoulis G, Rednic S, Bertsias G, Boumpas DT. EULAR recommendations for neuropsychiatric systemic lupus erythematosus vs usual care: results from two European centres. Rheumatology (Oxford). 2015 Jul;54(7):1270-8. doi: 10.1093/rheumatology/keu482. Epub 2015 Jan 30.'}, {'pmid': '10211873', 'type': 'BACKGROUND', 'citation': 'The American College of Rheumatology nomenclature and case definitions for neuropsychiatric lupus syndromes. Arthritis Rheum. 1999 Apr;42(4):599-608. doi: 10.1002/1529-0131(199904)42:43.0.CO;2-F.'}, {'pmid': '24514913', 'type': 'BACKGROUND', 'citation': 'Hanly JG. Diagnosis and management of neuropsychiatric SLE. Nat Rev Rheumatol. 2014 Jun;10(6):338-47. doi: 10.1038/nrrheum.2014.15. Epub 2014 Feb 11.'}]}, 'descriptionModule': {'briefSummary': 'Systemic lupus erythematosus (SLE) is a chronic autoimmune disease involving multiple organs, characterized by the production of autoantibodies and the development of tissue injury. The etiology of SLE is partially known, involving multiple genetic and environmental factors. As many as 50% of patients with SLE have neurological involvement during the course of their disease. Approximately 40% of neuropsychiatric SLE (NPSLE) cases are a consequence of the disease itself; other causes of NPSLE are infections, metabolic disorders, and side effects of drugs. The American College of Rheumatology identified 19 neuropsychiatric syndromes in SLE patients that can be divided into central and peripheral nervous system manifestations. Although this classification includes syndromes with no clear pathophysiological mechanism and is not specific for neuropsychiatric events caused exclusively by SLE, it helps the physician to recognize any neurological involvement . The most common clinical manifestations of juvenile neuropsychiatric SLE (NPSLE) are headache, cognitive dysfunction, mood disturbances and seizures. The pathophysiology of juvenile NPSLE is not yet fully known, but immunological and inflammatory factors, such as autoantibodies, cytokine and prothrombotic states are widely described . The of autoantibodies in the onset of specific clinical manifestations has also been recognized. Juvenile NPSLE manifestations are often difficult to diagnose (. Nineteen neuropsychiatric syndromes have been identified associated with SLE, can be divided into central and peripheral manifestations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study aims to include all children fulfilling the diagnostic criteria of SLE (The European League Against Rheumatism and The American College of Rheumatology (9)) attending to pediatric rheumatology and immunology clinic at Sohag University Hospitals during the study period', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study aims to include all children fulfilling the diagnostic criteria of SLE (The European League Against Rheumatism and The American College of Rheumatology (9)) attending to pediatric rheumatology and immunology clinic at Sohag University Hospitals during the study period.\n\nExclusion Criteria:\n\n* Children with other rheumatological disorders.; Neonates (infants \\> 1 month) Children with other neuropsychiatric disorders not attributed to SLE ( e.g. infection, metabolic disorders or side effects of drugs).'}, 'identificationModule': {'nctId': 'NCT06449794', 'briefTitle': 'Neuropsycatric Disorders Among Children With Systemic Lupus Erythematosus in Sohag University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Neuropsycatric Disorders Among Children With Systemic Lupus Erythematosus in Sohag University Hospital', 'orgStudyIdInfo': {'id': 'Soh-Med-24-05-10MS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Anti Phospholipid antibodies', 'type': 'DIAGNOSTIC_TEST', 'description': 'diagnosis of SLE'}, {'name': 'EEG', 'type': 'RADIATION', 'description': 'EEG for Cases with seizures.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Sohag', 'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag university Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Amira M Mahmoud, resident', 'role': 'CONTACT', 'email': 'amerah.mahmoud@med.sohag.edu.eg', 'phone': '01098129862'}, {'name': 'Montaser M Mohammed, assistant professor', 'role': 'CONTACT', 'phone': '01026372799'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident-pediatric department-sohag hospital university', 'investigatorFullName': 'Amira Mahmoud Ahmed', 'investigatorAffiliation': 'Sohag University'}}}}