<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03268096</url>
  </required_header>
  <id_info>
    <org_study_id>AGN_2017_6</org_study_id>
    <nct_id>NCT03268096</nct_id>
  </id_info>
  <brief_title>Disability, MRI Lesions and Thickness of Retinal Fibers: Evaluation 15 Years After a First Episode of Demyelination</brief_title>
  <acronym>DB-SEP15</acronym>
  <official_title>Disability, MRI Lesions and Thickness of Retinal Fibers: Evaluation 15 Years After a First Episode of Demyelination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Knowledge of the evolution of multiple sclerosis (MS) and its long-term prognostic factors is&#xD;
      essential to guide the therapeutic management. However, it remains partial and concerns above&#xD;
      all data collected during the first years of the disease. The evolution towards disability&#xD;
      can only be assessed after a follow-up of more than 10 years and does not depend solely on&#xD;
      the initial inflammatory activity of the disease. We propose to realize a standardized&#xD;
      clinical assessment, an optical coherence tomography (OCT) and a cerebral MRI 15 years after&#xD;
      the first clinical manifestation of the disease.&#xD;
&#xD;
      Clinical and paraclinical assessment will consist in the realization of additional MRI&#xD;
      sequences in order to obtain more precise information on cerebral lesions (unconventional&#xD;
      parameters). Optical coherence tomography (new generation device) will also be performed on&#xD;
      both eyes to describe the thickness of the different layers of the retina. A clinical&#xD;
      evaluation will be performed with the Expanded Disability Status Scale (EDSS).&#xD;
&#xD;
      This study aims:&#xD;
&#xD;
        1. to describe the current clinical situation of patients (e.g. percentage of patients with&#xD;
           moderate or severe disability)&#xD;
&#xD;
        2. to explore the associations between MRI parameters, those measured with OCT and clinical&#xD;
           characteristics (disability)&#xD;
&#xD;
        3. to explore clinical and paraclinical prognostic factors of pejorative evolution&#xD;
           (disability, severe cerebral atrophy, etc.)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 3, 2017</start_date>
  <completion_date type="Actual">November 3, 2021</completion_date>
  <primary_completion_date type="Actual">November 3, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Disability assessed with EDSS (Expanded Disability Status Scale)</measure>
    <time_frame>Baseline</time_frame>
    <description>Disability assessment will be carried out using the EDS (Expanded Disability Status) Scale.&#xD;
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)).</description>
  </primary_outcome>
  <enrollment type="Actual">182</enrollment>
  <condition>Multiple Sclerosis</condition>
  <condition>Pathologic Processes</condition>
  <condition>Tomography, Optical Coherence</condition>
  <condition>Magnetic Resonance Imaging</condition>
  <condition>Prognosis</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cerebral MRI and Optical Coherence Tomography</intervention_name>
    <description>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.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who had an episode of demyelination at least 10 years ago&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First episode of demyelination occurred at least 10 years ago&#xD;
&#xD;
          -  Hospitalized in the neurology department during this episode&#xD;
&#xD;
          -  Insured with a social security scheme&#xD;
&#xD;
          -  Having given his consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to 3 Tesla MRI and injection of contrast media&#xD;
&#xD;
          -  Benefiting from a legal protection measure&#xD;
&#xD;
          -  Pregnant or nursing mother&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antoine Guéguen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation Ophtalmologique A. de Rothschild</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondation Ophtalmologique A. de Rothschild</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Demyelinating Diseases</mesh_term>
    <mesh_term>Pathologic Processes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03268096
org study id: AGN_2017_6
nct id: NCT03268096
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.)
observational model: Case-Only
time perspective: Cross-Sectional
measure: Disability assessed with EDSS (Expanded Disability Status Scale)
time frame: Baseline
description: 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)).
intervention type: Device
intervention name: Cerebral MRI and Optical Coherence Tomography
description: 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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Antoine Guéguen, MD
role: Principal Investigator
affiliation: Fondation Ophtalmologique A. de Rothschild
facility: 
country: France
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Demyelinating Diseases
mesh term: Pathologic Processes
sharing ipd: Undecided