Disability, MRI Lesions and Thickness of Retinal Fibers: Evaluation 15 Years After a First Episode of Demyelination

Completed

• Conditions: Pathologic Processes; Multiple Sclerosis; Magnetic Resonance Imaging; Tomography, Optical Coherence; Prognosis

• Registration Number: NCT03268096
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

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.)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-03
• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-31
• Primary Completion: 2021-11-03
• Study Completion: 2021-11-03
• Status Verified: 2022-02
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disability assessed with EDSS (Expanded Disability Status Scale)	Baseline	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)).

Trial Locations

Locations (1)

Fondation Ophtalmologique A. de Rothschild; 🇫🇷 Paris, France