Clinical Patterns of Neuromyelitis Optica Spectrum Disorders in Assiut University Hospital

Completed

• Conditions: Neuromyelitis Optica Spectrum Disorder

• Registration Number: NCT03819413
• Lead Sponsor: Assiut University

Brief Summary

Neuromyelitis Optica Spectrum Disorders (NMOSD) are a group of inflammatory demyelinating disorders of the central nervous system. Although NMOSD occurs much more commonly in nations with a predominately non-Caucasian population, NMOSD are underestimated in Egypt and frequently misdiagnosed as multiple sclerosis (MS). In this study, by investigating serum anti-aquaporin (AQP) 4 and anti-MOG antibody of patients suspected to have NMOSD attending the Neurology and Psychiatry department of Assiut University Hospital, investigators aim to determine the relative frequency, clinical and radiological characteristics of NMOSD in upper Egypt community and compare it with other populations of different races.

Detailed Description

Neuromyelitis Optica Spectrum Disorders (NMOSD) are a group of inflammatory demyelinating disorders of the central nervous system characterized by episodes of immune-mediated demyelination and axonal damage mainly involving optic nerves and spinal cord. The discovery of a disease-specific serum NMO-immunoglobulin G (IgG) antibody that selectively binds aquaporin-4 (AQP4) has not only distinguish NMO from MS but also enabled an appreciation for the wide spectrum of this disorder. Another autoantibody is the Myelin oligodendrocyte glycoprotein (MOGIgG) antibody that has been increasingly reported in a variety of central nervous system neuroinflammatory conditions including patients with phenotypes typical for NMOSD. Overall, NMO occurs much more commonly in nations with a predominately non-Caucasian population,and estimated to be as high as 10 per 100,000. Differentiation of MS from NMOSD is critically important because disease modifying treatment for MS, are inefficacious in or may aggravate NMOSD. However, in Africa and Middle East, publications and studies are rare and most often focus on isolated cases that clearly do not reflect the epidemiological reality in this area. Investigators believe that detailed assessment of serum AQP4 antibody as well as anti-MOG antibody in Egyptian patients with suspected NMOSD or those with idiopathic inflammatory demyelinating central nervous system diseases (IIDCD) other than typical MS would be beneficial and Eventually will help to avoid unnecessary investigations and treatments, recurrent and prolonged hospital course, significant morbidity, and even death.

Study Timeline

• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-28
• Study Start: 2019-02-15
• Primary Completion: 2020-07-15
• Study Completion: 2020-08-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• All cases that fulfill the international 2015 consensus criteria of NMOSD

• Any episode suggestive of idiopathic inflammatory demyelinating central nervous system disease including

  • longitudinally extensive transverse myelitis (LETM) or optic neuritis (ON) plus Cerebral or Brainstem syndrome (LETM or ON PLUS)
  • optic neuritis (ON)
  • longitudinally extensive transverse myelitis (LETM),
  • Transverse myelitis with non-extensive lesion (NETM)
  • Acute encephalomyelitis (ADEM).

• Atypical MS cases (atypical clinical presentation, course, radiological findings or atypical response to treatment)

• Age: all patients of both sexes and all age groups will be included.

Exclusion Criteria

• Inclusion criteria for suspected NMOSD were not met
• An alternate diagnosis became apparent
• if no serum sample was supplied
• Subject declined to provide written informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the percentage of increase in NMOSD diagnostic rates by screening for serum anti-AQP4 and anti-MOG antibodies	one year period	To assess the role of screening for Serum anti-AQP4 and anti-MOG antibodies in patients with idiopathic inflammatory central nervous system demyelinating disorders on diagnostic rates of NMOSD

Secondary Outcome Measures

Name	Time	Method
the percentage of increase of anti-MOG associated diseases after screening for serum anti-MOG antibodies	one year period	To assess the impact of screening for serum anti-MOG antibodies on diagnostic rates of anti-MOG associated diseases
percentage of patients were misdiagnosed as MS after screening for serum anti-AQP4 and anti-MOG antibodies	one year period	To measure the role of Serum anti-AQP4 and anti-MOG antibodies to differentiate suspicious cases from MS

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt