Clinical Patterns of Neuromyelitis Optica Spectrum Disorders in Assiut University Hospital

November 5, 2020 updated by: doaa mokhtar mahmoud, Assiut University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71511
        • Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients suspected to have NMOSD according to the recent diagnostic criteria attending or referred to Neurology and Psychiatry department of Assiut University hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the percentage of increase in NMOSD diagnostic rates by screening for serum anti-AQP4 and anti-MOG antibodies
Time Frame: 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
one year period

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Noha A Abo Elfotoh, prof, Assuit University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2019

Primary Completion (Actual)

July 15, 2020

Study Completion (Actual)

August 30, 2020

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

January 24, 2019

First Posted (Actual)

January 28, 2019

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMOSD In Assiut University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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