Disability, MRI Lesions and Thickness of Retinal Fibers: Evaluation 15 Years After a First Episode of Demyelination (DB-SEP15)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03268096|
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : December 7, 2018
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:
- to describe the current clinical situation of patients (e.g. percentage of patients with moderate or severe disability)
- to explore the associations between MRI parameters, those measured with OCT and clinical characteristics (disability)
- to explore clinical and paraclinical prognostic factors of pejorative evolution (disability, severe cerebral atrophy, etc.)
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis Pathologic Processes Tomography, Optical Coherence Magnetic Resonance Imaging Prognosis||Device: Cerebral MRI and Optical Coherence Tomography|
|Study Type :||Observational|
|Estimated Enrollment :||298 participants|
|Official Title:||Disability, MRI Lesions and Thickness of Retinal Fibers: Evaluation 15 Years After a First Episode of Demyelination|
|Actual Study Start Date :||May 3, 2017|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
- Device: 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.
- Disability assessed with EDSS (Expanded Disability Status Scale) [ Time Frame: 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)).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268096
|Contact: Laurence Salomon, MD PhD||0148036431 ext +email@example.com|
|Contact: Antoine Guéguen, MD||0148036755 ext +firstname.lastname@example.org|
|Fondation Ophtalmologique A. de Rothschild||Recruiting|
|Contact: Antoine Guéguen, MD 0148036755 ext +33 email@example.com|
|Principal Investigator:||Antoine Guéguen, MD||Fondation Ophtalmologique A. de Rothschild|