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Disability, MRI Lesions and Thickness of Retinal Fibers: Evaluation 15 Years After a First Episode of Demyelination (DB-SEP15)

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ClinicalTrials.gov Identifier: NCT03268096
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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. 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.)

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
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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)).




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who had an episode of demyelination at least 10 years ago
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Laurence Salomon, MD PhD 0148036431 ext +33 lsalomon@for.paris
Contact: Antoine Guéguen, MD 0148036755 ext +33 agueguen@for.paris

Locations
France
Fondation Ophtalmologique A. de Rothschild Recruiting
Paris, France
Contact: Antoine Guéguen, MD    0148036755 ext +33    agueguen@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
Principal Investigator: Antoine Guéguen, MD Fondation Ophtalmologique A. de Rothschild

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03268096     History of Changes
Other Study ID Numbers: AGN_2017_6
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Autoimmune Diseases
Immune System Diseases