Systemic Lupus ErythematosusNCT06449794
Neuropsycatric Disorders Among Children With Systemic Lupus Erythematosus in Sohag University Hospital
An observational study of Systemic Lupus Erythematosus, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Anti Phospholipid antibodies and EEG
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Montaser M Mohammed, assistant professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag, Sohag
Magdy M Amin, professor
About this study
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
- Being tested
- Anti Phospholipid antibodies, EEG
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti Phospholipid antibodiesDiagnostic test
diagnosis of SLE
EEGRadiation
EEG for Cases with seizures.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mahmoud Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449794
- Sponsor's protocol ID
- Soh-Med-24-05-10MS
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23263866Pamfil 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.
PubMed 25638807The 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.
PubMed 10211873Hanly 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.
PubMed 24514913
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsycatric Disorders Among Children With Systemic Lupus Erythematosus in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06449794
- Acronym / sponsor ID
- Soh-Med-24-05-10MS
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti Phospholipid antibodiesdiagnosis of SLE | Diagnostic test | – |
| EEGEEG for Cases with seizures. | Radiation | – |
Primary outcome
detect the clinical spectrum of Neuropsycatric disorders in Children with SLE
Time frame: 1 year
the diagnostic criteria of SLE (The European League Against Rheumatism and The American College of Rheumatology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Background: PubMed 23263866Kozora 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.
- Background: PubMed 25638807Pamfil 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.
- Background: PubMed 10211873The 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.
- Background: PubMed 24514913Hanly 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Montaser M Mohammed, assistant professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira M Mahmoud, resident (01098129862, amerah.mahmoud@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detect the clinical spectrum of Neuropsycatric disorders in Children with SLE (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06449794, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.