MS (Multiple Sclerosis), NMO Spectrum Disorder (NMOSD)
Conditions
Brief summary
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
Interventions
None listed
Sponsors
Study design
Eligibility
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 \- 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum Glial Fibrillary Acidic Protein levels | Baseline | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between serum biomarkers (sGFAP and sNfL) and lesion burden on MRI. | Baseline | Correlation (Pearson or Spearman) between biomarker levels and total T2 lesion count at baseline MRI. |
| Correlation between serum biomarkers (sGFAP and sNfL) and Expanded Disability Status Scale (EDSS). | Baseline | Correlation analysis (Pearson or Spearman depending on distribution) between baseline serum concentrations of sGFAP/sNfL and baseline EDSS scores. |
| Association between serum biomarkers and optic nerve involvement (length and presence of LETM). | Baseline | Correlation between sGFAP/sNfL levels and MRI-measured optic nerve lesion length, including presence of longitudinally extensive transverse myelitis (LETM). |
| Diagnostic performance of sGFAP and combined sGFAP + sNfL in differentiating NMOSD from MS. | Baseline | Assessment of diagnostic accuracy using Area Under the Receiver Operating Characteristic Curve (AUC) for: 1. sGFAP alone 2. Combined biomarker model (sGFAP + sNfL) |