An observational study in Neuromyelitis Optica Spectrum Disorders, sponsored by IRCCS San Raffaele. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by IRCCS San Raffaele · Observational
The present research is an observational clinical study. The project aims to investigate astrocytic damage, assessed through biological findings such as an increase in GFAP level and/or MRI water index, in patients with NMOSD and its potential role in predicting demyelinating relapses or affecting disability outcomes. It will also explore predictors of astrocytic relapses, focusing on demographic, clinical, and immunological biomarkers like T cell responses, B cell repopulation, and cytokine levels. The goal is to identify unrecognized disease activity, providing insights for future research and clinical trials.
The study will involve 8 sites in Italy: 6 NMOSD clinical centers for patient enrolment and 2 centers for bioengineering and biological analysis. Centralized analysis of the MRI images of all patients enrolled in the clinical centers will be performed by the Neuroimaging Research Unit Fase 1 of San Raffaele Hospital. A total of 50 patients will be included and they will be followed for 12 months.
Comprehensive evaluation of patients, including clinical assessment, bioengineering evaluation, MRI, and blood samples, will be conducted at baseline, month 6, and month 12. To assess silent astrocytic relapses, a specialized evaluation will take place at months 3 and 9, including clinical analysis, blood samples to assess biomarkers like GFAP, a reduced MRI protocol to assess MRI water index, and bioengineering evaluation. In the case of a classical relapse, a dedicated visit will occur within 5 days of symptom onset, using the same evaluation protocol as at months 3 and 9 (MRI and biomarkers will be evaluated if not done in the month before).
162 studies on the registry are indexed under Neuromyelitis Optica; 72 are open to participants now.
This study's planned enrollment of 50 is below the median of 200 across 57 observational studies indexed under Neuromyelitis Optica.
Browse Neuromyelitis Optica studies →IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will include adult patients with NMOSD.
Exclusion Criteria:
Diagnostic Test: MRI · Diagnostic Test: Immunological Factors
MRI will be performed every 3 months from baseline to 1 year.
Immunological factors will be performed every 3 months from baseline to 1 year.
Identifying predictors of clinical relapse
The primary outcomes measures are: percentage of patients with relapse, defined by the occurrence of a novel/worsening NMOSD symptom (detected by patient reported outcomes or clinical judgment or bioengineering indexes) PLUS biological findings of astrocyte damage (increase of GFAP level and/or MRI water index).
Time frame: From enrollment to 12 months
Plan to share: No
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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IRCCS San Raffaele