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

NCT03268096 | Completed

• 1 other identifier: AGN_2017_6
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Cerebral MRI and Optical Coherence Tomography DEVICE

Clinical and paraclinical assessment (cerebral MRI and Optical Coherence Tomography) will be carried out on the same day. Paraclinical evaluation consists in the realization of additional MRI sequences in order to obtain more precise information on brain lesions (unconventional parameters). An optical coherence tomography will also be performed for both eyes to describe the thickness of the different layers of the retina.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique A. de Rothschild

Paris, France

Location

MeSH Terms

Conditions

Multiple Sclerosis; Pathologic Processes

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Antoine Guéguen, MD

  Fondation Ophtalmologique A. de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: August 31, 2017
• Study Start: May 3, 2017
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2021
• Last Updated: April 22, 2022

Record last verified: 2022-02

Locations

FR (1)