Clinical trial NCT02016222: Tear Analysis in the Diagnosis of Multiple Sclerosis
Official title: Tear Analysis in the Diagnosis of Primary Progressive Forms of Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Progressive Multiple Sclerosis
Keywords: primary progressive multiple sclerosis
diagnosis
tears
isoelectric focusing
oligoclonal bands
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2013-12-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: at baseline and two years after (+/- 2 months)
Secondary outcomes:
measure: Isoelectrophoretic profile of tears
timeFrame: Baseline and two years after inclusion
measure: Isoelectrophoretic profiles of tears by digital recording and analysis of images
timeFrame: Baseline and two years after
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre hospitalier universitaire (CHU), Nice
state: Alpes Maritimes
city: Lille
country: France
facility: Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
state: Nord
city: Bordeaux
country: France
facility: Centre hospitaliere universitaire
city: Caen
country: France
facility: Centre hospitalier universitaire
city: Clermont-Ferrand
country: France
facility: Centre hospitalier régional universitaire
city: Dijon
country: France
facility: Centre hospitalier universitaire
city: Lille
country: France
facility: Centre hospitalier régional universitaire
city: Lyon
country: France
facility: Hospices civils de Lyon
city: Marseille
country: France
facility: Assistance Publique - Hôpitaux de Marseille
city: Nancy
country: France
facility: Centre hospitalier universitaire
city: Nimes
country: France
facility: Centre hospitalier universitaire
city: Poissy
country: France
facility: Centre hospitalier intercommunal
city: Strasbourg
country: France
facility: Centre hospitalier régional universtaire
Study officials:
affiliation: Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
name: Patrick Hautecoeur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Groupement des Hôpitaux de l'Institut Catholique de Lille
name: Elisabeth Baumelou, MD
role: STUDY_CHAIR
affiliation: Centre Hospitalier Régional, Universitaire de Lille
name: Patrick Vermersch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Nice
name: Christine Lebrun-Frenay, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Régional Universitaire de Strasbourg
name: Jérome De Sèze, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire Dijon
name: Thibaut Moreau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Régional Universitaire de Clermont-Ferrand
name: Pierre Clavelou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre hospitalier intercommunal de Poissy
name: Olivier Heinzlef, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospices Civils de Lyon
name: Christian Confavreux, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Hospital, Nancy, France
name: Marc Debouverie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: L'assistance Publique des Hôpitaux de Marseille
name: Jean Pelletier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Bruno Brochet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Caen
name: Gilles Defer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Eric Thouvenot, MD
role: PRINCIPAL_INVESTIGATOR
References: