Neuromyelitis Optica Spectrum Disorder Clinical Trial
Official title:
Clinical Patterns of Neuromyelitis Optica Spectrum Disorders in Assiut University Hospital
Verified date | November 2020 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | August 30, 2020 |
Est. primary completion date | July 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut University Hospital | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Di Pauli F, Reindl M, Berger T. New clinical implications of anti-myelin oligodendrocyte glycoprotein antibodies in children with CNS demyelinating diseases. Mult Scler Relat Disord. 2018 May;22:35-37. doi: 10.1016/j.msard.2018.02.023. Epub 2018 Feb 22. Review. — View Citation
Holroyd KB, Aziz F, Szolics M, Alsaadi T, Levy M, Schiess N. Prevalence and characteristics of transverse myelitis and neuromyelitis optica spectrum disorders in the United Arab Emirates: A multicenter, retrospective study. Clin Exp Neuroimmunol. 2018 Aug;9(3):155-161. doi: 10.1111/cen3.12458. Epub 2018 May 7. — View Citation
Jarius S, Paul F, Aktas O, Asgari N, Dale RC, de Seze J, Franciotta D, Fujihara K, Jacob A, Kim HJ, Kleiter I, Kümpfel T, Levy M, Palace J, Ruprecht K, Saiz A, Trebst C, Weinshenker BG, Wildemann B. MOG encephalomyelitis: international recommendations on diagnosis and antibody testing. J Neuroinflammation. 2018 May 3;15(1):134. doi: 10.1186/s12974-018-1144-2. Review. — View Citation
Kim SM, Kim SJ, Lee HJ, Kuroda H, Palace J, Fujihara K. Differential diagnosis of neuromyelitis optica spectrum disorders. Ther Adv Neurol Disord. 2017 Jul;10(7):265-289. doi: 10.1177/1756285617709723. Epub 2017 May 24. Review. — View Citation
Lennon VA, Wingerchuk DM, Kryzer TJ, Pittock SJ, Lucchinetti CF, Fujihara K, Nakashima I, Weinshenker BG. A serum autoantibody marker of neuromyelitis optica: distinction from multiple sclerosis. Lancet. 2004 Dec 11-17;364(9451):2106-12. — View Citation
Pandit L, Asgari N, Apiwattanakul M, Palace J, Paul F, Leite MI, Kleiter I, Chitnis T; GJCF International Clinical Consortium & Biorepository for Neuromyelitis Optica. Demographic and clinical features of neuromyelitis optica: A review. Mult Scler. 2015 Jun;21(7):845-53. doi: 10.1177/1352458515572406. Epub 2015 Apr 28. Review. — View Citation
Weinshenker BG, Wingerchuk DM. Neuromyelitis Spectrum Disorders. Mayo Clin Proc. 2017 Apr;92(4):663-679. doi: 10.1016/j.mayocp.2016.12.014. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the percentage of increase in NMOSD diagnostic rates by screening for serum anti-AQP4 and anti-MOG antibodies | 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 | percentage of patients were misdiagnosed as MS after screening for serum anti-AQP4 and anti-MOG antibodies | To measure the role of Serum anti-AQP4 and anti-MOG antibodies to differentiate suspicious cases from MS | one year period | |
Secondary | the percentage of increase of anti-MOG associated diseases after screening for serum anti-MOG antibodies | To assess the impact of screening for serum anti-MOG antibodies on diagnostic rates of anti-MOG associated diseases | one year period |
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