An interventional study of tears sampling in Primary Progressive Multiple Sclerosis, sponsored by Lille Catholic University. Terminated at 13 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Lille Catholic University · Not applicable, Interventional, and Diagnostic
In the primary progressive multiple sclerosis, the detection of oligoclonal bands in cerebrospinal fluid is critical for the diagnosis. However, lumbar puncture for cerebrospinal fluid collection is considered relatively invasive. Our hypothesis is that oligoclonal bands detection in tears is possible and useful for the diagnosis of multiple sclerosis.
The objective of the present study is to assess concordance between oligoclonal bands detection in tears and in cerebrospinal fluid. We will include patients with primary progressive multiple sclerosis and we will compare results of oligoclonal bands detection by isoelectric focusing in cerebrospinal fluid and tears. Tears will be collected using a Schirmer strip. This would circumvent the practice of invasive lumbar punctures currently used in multiple sclerosis diagnosis.
Exclusion Criteria:
Procedure: tears sampling
Concordance between the quantification of oligoclonal IgG bands by isoelectric focusing in tears and in the cerebrospinal fluid in patients with primary progressive multiple sclerosis
Time frame: at baseline and two years after (+/- 2 months)
Isoelectrophoretic profile of tears
Determination of the stability and prognostic value of isoelectrophoretic profile of tears at inclusion, after 2 years.
Time frame: Baseline and two years after inclusion
Isoelectrophoretic profiles of tears by digital recording and analysis of images
Time frame: Baseline and two years after
This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Multiple Sclerosis, Chronic Progressive→
Lille Catholic University