Tear Analysis in the Diagnosis of Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Tear Analysis in the Diagnosis of Primary Progressive Forms of Multiple Sclerosis

Conditions
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Primary Progressive Multiple Sclerosis

Intervention / Treatment
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* Procedure: tears sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or more Progressive neurological deficit after 12 months At least 9 T2 brain lesions of minimum 3 mm evidenced by MRI and/or four or more T2 lesions of minimum 3 mm with positive Visual Evoked Potential and/or positive spinal cord MRI (at least two focal T2 lesions) Exclusion Criteria: Asiatic persons recurrent forms of the disease Persons wearing contact lenses Ocular Infection Corticoid treatment at least 30 days before sampling immunosuppressive or immunomodulatory treatment 3 months before sampling

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tears sampling<br> | Procedure: tears sampling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | at baseline and two years after (+/- 2 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isoelectrophoretic profile of tears | Determination of the stability and prognostic value of isoelectrophoretic profile of tears at inclusion, after 2 years. | Baseline and two years after inclusion | 
| Isoelectrophoretic profiles of tears by digital recording and analysis of images |  | Baseline and two years after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary progressive multiple sclerosis, diagnosis, tears, isoelectric focusing, oligoclonal bands