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
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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COMPLETED
182 participants
OBSERVATIONAL
2017-05-03
2021-11-03
Brief Summary
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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.)
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Benefiting from a legal protection measure
* Pregnant or nursing mother
ALL
No
Sponsors
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Fondation Ophtalmologique Adolphe de Rothschild
NETWORK
Responsible Party
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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
Countries
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Other Identifiers
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AGN_2017_6
Identifier Type: -
Identifier Source: org_study_id
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