An observational study in Multiple Sclerosis, Pathologic Processes and Tomography, Optical Coherence, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2022-04-22.
Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational
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:
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's enrollment of 182 is above the median of 100 across 970 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.
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Patients who had an episode of demyelination at least 10 years ago
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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)).
Time frame: Baseline
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from May 2017 to primary completion in Nov 2021, 54 months.
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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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