Neuropsycatric Disorders Among Children With Systemic Lupus Erythematosus in Sohag University Hospital

NCT06449794 | Recruiting

• 1 other identifier: Soh-Med-24-05-10MS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• detect the clinical spectrum of Neuropsycatric disorders in Children with SLE

  the diagnostic criteria of SLE (The European League Against Rheumatism and The American College of Rheumatology

  1 year

Interventions

Anti Phospholipid antibodies DIAGNOSTIC_TEST

diagnosis of SLE

EEG RADIATION

EEG for Cases with seizures.

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Sohag, Egypt

RECRUITING

Related Publications (4)

• 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: 23263866 BACKGROUND

• 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: 25638807 BACKGROUND

• 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: 10211873 BACKGROUND

• 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.

  PMID: 24514913 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Amira M Mahmoud, resident

CONTACT

01098129862; amerah.mahmoud@med.sohag.edu.eg

Montaser M Mohammed, assistant professor

CONTACT

01026372799

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident-pediatric department-sohag hospital university

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

EG (1)