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

NCT ID: NCT03268096

Last Updated: 2022-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

182 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-03

Study Completion Date

2021-11-03

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Cerebral MRI and Optical Coherence Tomography

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antoine Guéguen, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Ophtalmologique A. de Rothschild

Locations

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Fondation Ophtalmologique A. de Rothschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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AGN_2017_6

Identifier Type: -

Identifier Source: org_study_id

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