Tear Analysis in the Diagnosis of Multiple Sclerosis (LARMES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02016222
Recruitment Status : Completed
First Posted : December 19, 2013
Last Update Posted : September 20, 2016
Information provided by (Responsible Party):
Lille Catholic University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Progressive Multiple Sclerosis Procedure: tears sampling Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Tear Analysis in the Diagnosis of Primary Progressive Forms of Multiple Sclerosis
Study Start Date : April 2011
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Tears sampling Procedure: tears sampling

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Isoelectrophoretic profile of tears [ Time Frame: Baseline and two years after inclusion ]
    Determination of the stability and prognostic value of isoelectrophoretic profile of tears at inclusion, after 2 years.

  2. Isoelectrophoretic profiles of tears by digital recording and analysis of images [ Time Frame: Baseline and two years after ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02016222

Centre hospitalier universitaire (CHU), Nice
Nice, Alpes Maritimes, France, 06003
Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
Lille, Nord, France, 59000
Centre hospitaliere universitaire
Bordeaux, France, 33404
Centre hospitalier universitaire
Caen, France, 14033
Centre hospitalier régional universitaire
Clermont-Ferrand, France, 63003
Centre hospitalier universitaire
Dijon, France, 21079
Centre hospitalier régional universitaire
Lille, France, 59037
Hospices civils de Lyon
Lyon, France, 69229
Assistance Publique - Hôpitaux de Marseille
Marseille, France, 13354
Centre hospitalier universitaire
Nancy, France, 54035
Centre hospitalier universitaire
Nimes, France, 30029
Centre hospitalier intercommunal
Poissy, France, 78303
Centre hospitalier régional universtaire
Strasbourg, France, 67091
Sponsors and Collaborators
Lille Catholic University
Principal Investigator: Patrick Hautecoeur, MD Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
Study Chair: Elisabeth Baumelou, MD Groupement des Hôpitaux de l'Institut Catholique de Lille
Principal Investigator: Patrick Vermersch, MD, PhD Centre Hospitalier Régional, Universitaire de Lille
Principal Investigator: Christine Lebrun-Frenay, MD, PhD Centre Hospitalier Universitaire de Nice
Principal Investigator: Jérome De Sèze, MD, PhD Centre Hospitalier Régional Universitaire de Strasbourg
Principal Investigator: Thibaut Moreau, MD Centre Hospitalier Universitaire Dijon
Principal Investigator: Pierre Clavelou, MD Centre Hospitalier Régional Universitaire de Clermont-Ferrand
Principal Investigator: Olivier Heinzlef, MD Centre hospitalier intercommunal de Poissy
Principal Investigator: Christian Confavreux, MD Hospices Civils de Lyon
Principal Investigator: Marc Debouverie, MD, PhD Central Hospital, Nancy, France
Principal Investigator: Jean Pelletier, MD, PhD L'assistance Publique des Hôpitaux de Marseille
Principal Investigator: Bruno Brochet, MD, PhD University Hospital, Bordeaux
Principal Investigator: Gilles Defer, MD Centre Hospitalier universitaire de Caen
Principal Investigator: Eric Thouvenot, MD Centre Hospitalier Universitaire de Nîmes

Responsible Party: Lille Catholic University Identifier: NCT02016222     History of Changes
Other Study ID Numbers: RC-P0006
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016

Keywords provided by Lille Catholic University:
primary progressive multiple sclerosis
isoelectric focusing
oligoclonal bands

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases