Primary Progressive Multiple Sclerosis
Conditions
Keywords
primary progressive multiple sclerosis, diagnosis, tears, isoelectric focusing, oligoclonal bands
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.
Interventions
PROCEDUREtears sampling
Sponsors
Lille Catholic University
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| Isoelectrophoretic profile of tears | Baseline and two years after inclusion | Determination of the stability and prognostic value of isoelectrophoretic profile of tears at inclusion, after 2 years. |
| Isoelectrophoretic profiles of tears by digital recording and analysis of images | Baseline and two years after | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPatrick Hautecoeur, MD
Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
STUDY_CHAIRElisabeth Baumelou, MD
Groupement des Hôpitaux de l'Institut Catholique de Lille
PRINCIPAL_INVESTIGATORPatrick Vermersch, MD, PhD
Centre Hospitalier Régional, Universitaire de Lille
PRINCIPAL_INVESTIGATORChristine Lebrun-Frenay, MD, PhD
Centre Hospitalier Universitaire de Nice
PRINCIPAL_INVESTIGATORJérome De Sèze, MD, PhD
Centre Hospitalier Régional Universitaire de Strasbourg
PRINCIPAL_INVESTIGATORThibaut Moreau, MD
Centre Hospitalier Universitaire Dijon
PRINCIPAL_INVESTIGATORPierre Clavelou, MD
Centre Hospitalier Régional Universitaire de Clermont-Ferrand
PRINCIPAL_INVESTIGATOROlivier Heinzlef, MD
Centre hospitalier intercommunal de Poissy
PRINCIPAL_INVESTIGATORChristian Confavreux, MD
Hospices Civils de Lyon
PRINCIPAL_INVESTIGATORMarc Debouverie, MD, PhD
Central Hospital, Nancy, France
PRINCIPAL_INVESTIGATORJean Pelletier, MD, PhD
L'assistance Publique des Hôpitaux de Marseille
PRINCIPAL_INVESTIGATORBruno Brochet, MD, PhD
University Hospital, Bordeaux
PRINCIPAL_INVESTIGATORGilles Defer, MD
Centre Hospitalier Universitaire de Caen
PRINCIPAL_INVESTIGATOREric Thouvenot, MD
Centre Hospitalier Universitaire de Nīmes
Outcome results
None listed