<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/NCT04448938</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A01560-39</org_study_id>
    <nct_id>NCT04448938</nct_id>
  </id_info>
  <brief_title>RESting-state Functional MRI in Patients With Optic Neuritis for ANticipation of reCovEry</brief_title>
  <acronym>RESONANCE</acronym>
  <official_title>RESting-state Functional MRI in Patients With Optic Neuritis for ANticipation of reCovEry</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>
      When patients arrive in the waiting room of the MRI department, patients will be given the&#xD;
      briefing note explaining the purpose of the study and how it is going. During the&#xD;
      consultation, the radiologist will check the inclusion and non-inclusion criteria, and will&#xD;
      take the time to answer all of the patient's questions about the study. If the patient agrees&#xD;
      to participate in the research, the investigating doctor will obtain his consent.&#xD;
&#xD;
      The MRI examination will be performed on a 3T multi-parametric MRI. Compared to the standard&#xD;
      protocol, patients will benefit from an additional sequence of f-mRI, called resting state,&#xD;
      and performed before injection of gadolinium contrast agent.&#xD;
&#xD;
      A consultation with an ophthalmologist will also be carried out the same day, at the Adolphe&#xD;
      de Rothschild Foundation. During this visit, an OCT examination (optical coherence&#xD;
      tomography), a visual field as well as the measurement of visual acuity will be carried out,&#xD;
      in accordance with the treatment usually practiced at the Adolphe de Rothschild Foundation.&#xD;
&#xD;
      The subjects of the control group who agreed to participate will benefit from an MRI&#xD;
      examination which will include, in addition to the sequences planned for these patients&#xD;
      according to their indications, the two non-injected sequences which will be performed on&#xD;
      patients with suspected NO.&#xD;
&#xD;
      The possible existence of visual problems in the subjects of the control group will also be&#xD;
      asked to them by interrogation. No eye exams or follow-up visits are planned, and control&#xD;
      group participation will end after the MRI scan.&#xD;
&#xD;
      Patients with NO will be seen in consultation by an ophthalmologist during a follow-up visit&#xD;
      approximately 6 months after diagnosis. During this consultation, an OCT, a visual field and&#xD;
      the measurement of visual acuity will be performed. This visit and the examinations carried&#xD;
      out correspond to the usual care of patients suffering from NO and followed at the Adolphe de&#xD;
      Rothschild Foundation Hospital.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 17, 2020</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The ophthalmological functional recovery will be assessed by measuring the low contrast visual acuity on the Early Treatment Diabetic Retinopathy study scale (ETDRS scale).</measure>
    <time_frame>6 months</time_frame>
    <description>ETDRS charts presents a serie of 70 letters. The visual acuity letter score is equal to the total number of letters read correctly at 4.0 m. The score ranged to 20/10 (best visual acuity) to 20/20 000 (worst visual acuity).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Neuritis</condition>
  <arm_group>
    <arm_group_label>optic neuritis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>The MRI examination will be performed on a 3T multi-parametric MRI. Compared to the standard protocol, patients will benefit from an additional sequence of f-mRI, called resting state, and performed before injection of gadolinium contrast agent.&#xD;
A consultation with an ophthalmologist will also be carried out the same day, at the Adolphe de Rothschild Foundation.&#xD;
The subjects of the control group who agreed to participate will benefit from an MRI examination which will include, in addition to the sequences planned for these patients according to their indications, the two non-injected sequences which will be performed on patients with suspected NO.</description>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>optic neuritis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>visual acuity</intervention_name>
    <description>Patients with NO will be seen in consultation by an ophthalmologist during a follow-up visit approximately 6 months after diagnosis. During this consultation, an OCT, a visual field and the measurement of visual acuity will be performed. This visit and the examinations carried out correspond to the usual care of patients suffering from NO and followed at the Adolphe de Rothschild Foundation Hospital</description>
    <arm_group_label>optic neuritis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with clinical suspicion of NO who must perform an MRI for the diagnosis of NO. A&#xD;
        control group will also be set up to compare the visual functional networks of patients&#xD;
        with NO with those of a sample of subjects free from NO.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years of age&#xD;
&#xD;
          -  Clinical suspicion of optic neuritis&#xD;
&#xD;
          -  Benefiting from an MRI for exploration of optic neuritis&#xD;
&#xD;
          -  Affiliate or beneficiary of a social security scheme&#xD;
&#xD;
          -  Having received informed information about the study and having given their express&#xD;
             consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to absolute or relative MRI (in particular, pregnant or breastfeeding&#xD;
             women)&#xD;
&#xD;
          -  History of amblyopia&#xD;
&#xD;
          -  Any pre-existing pathology leading to a decrease in vision (e.g. retinitis pigmentosa,&#xD;
             AMD, etc.)&#xD;
&#xD;
          -  Patient benefiting from a legal protection measure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fondation A De Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amélie YAVCHITZ</last_name>
      <phone>0148036431</phone>
      <email>ayavchitz@for.paris</email>
    </contact>
    <investigator>
      <last_name>Sidney KRYSTAL</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</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>Neuritis</mesh_term>
    <mesh_term>Optic Neuritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04448938
org study id: 2020-A01560-39
nct id: NCT04448938
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
When patients arrive in the waiting room of the MRI department, patients will be given the
      briefing note explaining the purpose of the study and how it is going. During the
      consultation, the radiologist will check the inclusion and non-inclusion criteria, and will
      take the time to answer all of the patient's questions about the study. If the patient agrees
      to participate in the research, the investigating doctor will obtain his consent.

      The MRI examination will be performed on a 3T multi-parametric MRI. Compared to the standard
      protocol, patients will benefit from an additional sequence of f-mRI, called resting state,
      and performed before injection of gadolinium contrast agent.

      A consultation with an ophthalmologist will also be carried out the same day, at the Adolphe
      de Rothschild Foundation. During this visit, an OCT examination (optical coherence
      tomography), a visual field as well as the measurement of visual acuity will be carried out,
      in accordance with the treatment usually practiced at the Adolphe de Rothschild Foundation.

      The subjects of the control group who agreed to participate will benefit from an MRI
      examination which will include, in addition to the sequences planned for these patients
      according to their indications, the two non-injected sequences which will be performed on
      patients with suspected NO.

      The possible existence of visual problems in the subjects of the control group will also be
      asked to them by interrogation. No eye exams or follow-up visits are planned, and control
      group participation will end after the MRI scan.

      Patients with NO will be seen in consultation by an ophthalmologist during a follow-up visit
      approximately 6 months after diagnosis. During this consultation, an OCT, a visual field and
      the measurement of visual acuity will be performed. This visit and the examinations carried
      out correspond to the usual care of patients suffering from NO and followed at the Adolphe de
      Rothschild Foundation Hospital.
observational model: Case-Control
time perspective: Prospective
measure: The ophthalmological functional recovery will be assessed by measuring the low contrast visual acuity on the Early Treatment Diabetic Retinopathy study scale (ETDRS scale).
time frame: 6 months
description: ETDRS charts presents a serie of 70 letters. The visual acuity letter score is equal to the total number of letters read correctly at 4.0 m. The score ranged to 20/10 (best visual acuity) to 20/20 000 (worst visual acuity).
arm group label: optic neuritis
arm group label: control
intervention type: Other
intervention name: MRI
description: The MRI examination will be performed on a 3T multi-parametric MRI. Compared to the standard protocol, patients will benefit from an additional sequence of f-mRI, called resting state, and performed before injection of gadolinium contrast agent.
A consultation with an ophthalmologist will also be carried out the same day, at the Adolphe de Rothschild Foundation.
The subjects of the control group who agreed to participate will benefit from an MRI examination which will include, in addition to the sequences planned for these patients according to their indications, the two non-injected sequences which will be performed on patients with suspected NO.
arm group label: control
arm group label: optic neuritis
intervention type: Other
intervention name: visual acuity
description: Patients with NO will be seen in consultation by an ophthalmologist during a follow-up visit approximately 6 months after diagnosis. During this consultation, an OCT, a visual field and the measurement of visual acuity will be performed. This visit and the examinations carried out correspond to the usual care of patients suffering from NO and followed at the Adolphe de Rothschild Foundation Hospital
arm group label: optic neuritis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Neuritis
mesh term: Optic Neuritis
sharing ipd: No