Disability, MRI Lesions and Thickness of Retinal Fibers: Evaluation 15 Years After a First Episode of Demyelination (DB-SEP15)

Knowledge of the evolution of multiple sclerosis (MS) and its long-term prognostic factors is essential to guide the therapeutic management. However, it remains partial and concerns above all data collected during the first years of the disease. The evolution towards disability can only be assessed after a follow-up of more than 10 years and does not depend solely on the initial inflammatory activity of the disease. We propose to realize a standardized clinical assessment, an optical coherence tomography (OCT) and a cerebral MRI 15 years after the first clinical manifestation of the disease.

Clinical and paraclinical assessment will consist in the realization of additional MRI sequences in order to obtain more precise information on cerebral lesions (unconventional parameters). Optical coherence tomography (new generation device) will also be performed on both eyes to describe the thickness of the different layers of the retina. A clinical evaluation will be performed with the Expanded Disability Status Scale (EDSS).

This study aims:

1. to describe the current clinical situation of patients (e.g. percentage of patients with moderate or severe disability)
2. to explore the associations between MRI parameters, those measured with OCT and clinical characteristics (disability)
3. to explore clinical and paraclinical prognostic factors of pejorative evolution (disability, severe cerebral atrophy, etc.)

Study Overview

• Status: Completed
• Conditions: Pathologic Processes; Multiple Sclerosis; Magnetic Resonance Imaging; Prognosis; Tomography, Optical Coherence
• Intervention / Treatment: Device: Cerebral MRI and Optical Coherence Tomography

• Study Type: Observational
• Enrollment (Actual): 182

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Fondation Ophtalmologique A. de Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who had an episode of demyelination at least 10 years ago

Description

Inclusion Criteria:

• First episode of demyelination occurred at least 10 years ago
• Hospitalized in the neurology department during this episode
• Insured with a social security scheme
• Having given his consent to participate in the study

Exclusion Criteria:

• Contraindications to 3 Tesla MRI and injection of contrast media
• Benefiting from a legal protection measure
• Pregnant or nursing mother

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability assessed with EDSS (Expanded Disability Status Scale)	Disability assessment will be carried out using the EDS (Expanded Disability Status) Scale. This scale ranges from 0 to 10. Binary or ordered variables will be considered with various thresholds (for example, a score equal to 3 corresponds to moderate disorders ; a score equal to 6 corresponds to major disorders (need of a stick to walk 100 meters)).	Baseline

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Antoine Guéguen, MD, Fondation Ophtalmologique A. de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2017
• Primary Completion (Actual): November 3, 2021
• Study Completion (Actual): November 3, 2021

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Multiple Sclerosis; Demyelinating Diseases; Pathologic Processes
• Other Study ID Numbers: AGN_2017_6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No