Multiple Sclerosis Versus Neuromyelitis Optica Spectrum Disorder
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorAssiut University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial population
Patients attending toassuit hospitals
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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).
Time frame
BaselineSecondary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Baseline3
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).
Time frame
Baseline4
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: 1. sGFAP alone 2. Combined biomarker model (sGFAP + sNfL)
Time frame
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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