Multiple Sclerosis Versus Neuromyelitis Optica Spectrum Disorder

Comparative Study Between Multiple Sclerosis Versus Neuromyelitis Optica Spectrum Disorder Patients in Assiut Hospitals Clinical and Laboratory Study

The aim of this work is to do a detailed comparison between multiple sclerosis and Neuromyelitis Optica Spectrum Disorder due to delicate similarities between both diseases and wide rang of management and follow up of the patients

Study Overview

• Status: Not yet recruiting
• Conditions: NMO Spectrum Disorder (NMOSD); MS (Multiple Sclerosis)

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Hussein Abdelrahem Hussein, resident; Phone Number: 0201151220581; Email: hussein.17289842@med.aun.eg
• Study Contact Backup: Name: Eman Mohamed Hussein, professor; Phone Number: 020 10 05850632; Email: emankhedr99@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients attending toassuit hospitals

Description

Inclusion Criteria:1- Both sex 2- Aged between 18 and 50 years. All included patients were in a clinically stable phase and had not experienced a relapse within at least three months before blood sampling. 3- All patients diagnosed as MS patients either naive or on disease modifying therapies according to The new diagnostic criteria MacDonalds 2024 4- DMT-naïve NMOSD patients: Diagnosed with MS based on the 2017 McDonald Criteria (Thompson et al., 2018)

5- An informed consent will be obtained from all the patients; the study will be approved by ethical committee in faculty of Medicine Assiut University

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1_ Presence of other disorder that mimic MS or NMOSD 3_ Patients failed to commit to the follow up visits and regular MRI scans 4_ Patients refused to sign the written informed consent

Exclusion Criteria:

• 1_ Presence of other disorder that mimic MS or NMOSD 3_ Patients failed to commit to the follow up visits and regular MRI scans 4_ Patients refused to sign the written informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum Glial Fibrillary Acidic Protein levels	Measurement of serum concentrations of Glial Fibrillary Acidic Protein at baseline using a validated immunoassay (e.g., single-molecule array [Simoa] assay). difference in serum Glial Fibrillary Acidic Protein levels between treatment-naïve NMOSD and treatment-naïve MS patientsexpressed in picograms per milliliter (pg/mL).	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between serum biomarkers (sGFAP and sNfL) and lesion burden on MRI.	Correlation (Pearson or Spearman) between biomarker levels and total T2 lesion count at baseline MRI.	Baseline
Correlation between serum biomarkers (sGFAP and sNfL) and Expanded Disability Status Scale (EDSS).	Correlation analysis (Pearson or Spearman depending on distribution) between baseline serum concentrations of sGFAP/sNfL and baseline EDSS scores.	Baseline
Association between serum biomarkers and optic nerve involvement (length and presence of LETM).	Correlation between sGFAP/sNfL levels and MRI-measured optic nerve lesion length, including presence of longitudinally extensive transverse myelitis (LETM).	Baseline
Diagnostic performance of sGFAP and combined sGFAP + sNfL in differentiating NMOSD from MS.	Assessment of diagnostic accuracy using Area Under the Receiver Operating Characteristic Curve (AUC) for: sGFAP alone; Combined biomarker model (sGFAP + sNfL)	Baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.
• Wingerchuk DM, Banwell B, Bennett JL, Cabre P, Carroll W, Chitnis T, de Seze J, Fujihara K, Greenberg B, Jacob A, Jarius S, Lana-Peixoto M, Levy M, Simon JH, Tenembaum S, Traboulsee AL, Waters P, Wellik KE, Weinshenker BG; International Panel for NMO Diagnosis. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders. Neurology. 2015 Jul 14;85(2):177-89. doi: 10.1212/WNL.0000000000001729. Epub 2015 Jun 19.
• Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sorensen PS, Thompson AJ, Wolinsky JS, Balcer LJ, Banwell B, Barkhof F, Bebo B Jr, Calabresi PA, Clanet M, Comi G, Fox RJ, Freedman MS, Goodman AD, Inglese M, Kappos L, Kieseier BC, Lincoln JA, Lubetzki C, Miller AE, Montalban X, O'Connor PW, Petkau J, Pozzilli C, Rudick RA, Sormani MP, Stuve O, Waubant E, Polman CH. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86. doi: 10.1212/WNL.0000000000000560. Epub 2014 May 28.
• Rae-Grant A, Day GS, Marrie RA, Rabinstein A, Cree BAC, Gronseth GS, Haboubi M, Halper J, Hosey JP, Jones DE, Lisak R, Pelletier D, Potrebic S, Sitcov C, Sommers R, Stachowiak J, Getchius TSD, Merillat SA, Pringsheim T. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2018 Apr 24;90(17):777-788. doi: 10.1212/WNL.0000000000005347.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 22, 2030
• Study Completion (Estimated): December 22, 2030

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Multiple Sclerosis; Neuromyelitis Optica
• Other Study ID Numbers: MS VS NMO-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No