Tear Analysis in the Diagnosis of Multiple Sclerosis (LARMES)

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Progressive Multiple Sclerosis
• Intervention / Treatment: Procedure: tears sampling

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
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33404
    • Centre hospitaliere universitaire
  • Caen, France, 14033
    • Centre Hospitalier Universitaire
  • Clermont-Ferrand, France, 63003
    • Centre Hospitalier Régional Universitaire
  • Dijon, France, 21079
    • Centre Hospitalier Universitaire
  • Lille, France, 59037
    • Centre Hospitalier Régional Universitaire
  • Lyon, France, 69229
    • Hospices civils de Lyon
  • Marseille, France, 13354
    • Assistance Publique - Hopitaux de Marseille
  • Nancy, France, 54035
    • Centre Hospitalier Universitaire
  • Nimes, France, 30029
    • Centre Hospitalier Universitaire
  • Poissy, France, 78303
    • Centre Hospitalier Intercommunal
  • Strasbourg, France, 67091
    • Centre hospitalier régional universtaire
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 06003
      • Centre hospitalier universitaire (CHU), Nice
  • Nord
    • Lille, Nord, France, 59000
      • Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tears sampling	Procedure: tears sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Collaborators: Bayer
• Investigators: Principal Investigator: Christian Confavreux, MD, Hospices civils de Lyon; 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: Jérôme de Seze, 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: 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 Nīmes

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: December 18, 2013
• First Posted (Estimate): December 19, 2013

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 19, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: diagnosis; tears; primary progressive multiple sclerosis; isoelectric focusing; oligoclonal bands
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
• Other Study ID Numbers: RC-P0006