This trial is active, not recruiting.

Conditions clinically isolated syndrome, multiple sclerosis
Treatment tears and cerebrospinal fluid sampling
Sponsor Lille Catholic University
Start date October 2012
End date June 2018
Trial size 165 participants
Trial identifier NCT02043964, RC-P0021


This is a multicentric and prospective study for the validation of a diagnostic method in multiple sclerosis. Our hypothesis is that there is a characteristic profile of tears that can be recognized in order to help in the diagnosis of this pathology and that could possibly replace the lumbar punction which is an invasive method. Semi-automatic and automatic techniques of isoelectric focusing will be developed for analyzing data from tears. These results will help in the identification of markers of this disease.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
tears and cerebrospinal fluid sampling
All patients recruited in this study will undergo a cerebrospinal fluid sampling which is an invasive procedure included in the actual routine practice. In addition a sampling from eyes will be obtain using the Schirmer test to get tears from the lacrimal gland.

Primary Outcomes

Concordance between the quantification of oligoclonal IgG bands in tears and in cerebrospinal fluid by isoelectric focusing in patients with clinically isolated syndrome
time frame: two years after

Secondary Outcomes

Diagnostic performance of isoelectric focusing of tears
time frame: inclusion, two years after
Concordance between visual and automatic reading of electrophoretic profiles
time frame: two years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 18 years old or more - Clinically isolated syndrome of less than 3 months of onset - Informed consent to participate Exclusion Criteria: - Progressive primary multiple sclerosis - Relapsing remitting multiple sclerosis - Persons wearing contact lenses - Ocular Infection - Corticoid treatment at least 30 days before sampling - Immunosuppressive or immunomodulatory treatment at least 3 months before sampling - Pregnancy or breast feeding - No coverage by the Social Insurance

Additional Information

Official title Tear Analysis by Isoelectric Focusing in Clinically Isolated Syndrome as Multiple Sclerosis Criterion Among Patients With or Without Lesions at the Magnetic Resonance Imaging (Oligoclonal Profile of Tears)
Principal investigator Patrick Hautecoeur, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Lille Catholic University.