xml: <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/NCT05982925</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY-21-01855</org_study_id>
      <nct_id>NCT05982925</nct_id>
    </id_info>
    <brief_title>Longitudinal Cortical Demyelination in Multiple Sclerosis and Related Disorders</brief_title>
    <official_title>Longitudinal Investigation of Cortical Demyelination and Meningeal Inflammation in Multiple Sclerosis and Related Disorders</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Icahn School of Medicine at Mount Sinai</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Icahn School of Medicine at Mount Sinai</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this protocol, a combination of MRI, blood, and cerebrospinal fluid (CSF) analysis will be&#xD;
        used to understand the natural history, underlying immunologic mechanisms, and clinical&#xD;
        implications of central nervous system (CNS) lesions, in particular lesions in the cerebral&#xD;
        cortex, in multiple sclerosis (MS) and other inflammatory and autoimmune disorders affecting&#xD;
        the CNS. Patients with these disorders, as well as healthy controls, will undergo baseline&#xD;
        clinical evaluation and testing, bloodwork, and MRI, with follow up clinical evaluation,&#xD;
        bloodwork, and MRI at years 1, 3, and 6. Additional MRIs may be performed in patients with&#xD;
        possible new lesion formation or to compare MRI techniques. Lumbar puncture will be performed&#xD;
        on participants who are not currently being treated with disease modifying therapies and who&#xD;
        are willing to undergo the procedure.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 6, 2022</start_date>
    <completion_date type="Anticipated">May 1, 2030</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2030</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Cortical Lesion Number</measure>
      <time_frame>at 6 years (end of study)</time_frame>
      <description>Lesions in the cerebral cortex</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Multiple Sclerosis</condition>
    <condition>Neuromyelitis Optica</condition>
    <condition>Demyelinating Autoimmune Diseases, CNS</condition>
    <arm_group>
      <arm_group_label>MS Participant</arm_group_label>
      <description>Adults with multiple sclerosis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Participant</arm_group_label>
      <description>Adults without neurologic disease</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Other Neuroinflammatory Participants</arm_group_label>
      <description>Adults with a neuroinflammatory disease that is not multiple sclerosis</description>
    </arm_group>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood and cerebrospinal fluid&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Adults with MS or other neuroinflammatory diseases and healthy volunteers&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years old&#xD;
  &#xD;
            -  able to provide consent in English&#xD;
  &#xD;
            -  able to undergo MRI&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  contraindication to MRI&#xD;
  &#xD;
            -  pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Erin S Beck, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Erin S Beck, MD, PhD</last_name>
      <phone>212-241-2474</phone>
      <email>erin.beck@mssm.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Julia L Galasso, BS</last_name>
      <phone>212-241-9463</phone>
      <email>julia.galasso@mssm.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Mount Sinai Hospital</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10029</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Erin S Beck, MD, PhD</last_name>
        <phone>212-241-2474</phone>
        <email>erin.beck@mssm.edu</email>
      </contact>
      <contact_backup>
        <last_name>Julia L Galasso, BS</last_name>
        <phone>212-241-9463</phone>
        <email>julia.galasso@mssm.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Erin S Beck</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
      <investigator_full_name>Erin Beck</investigator_full_name>
      <investigator_title>Assistant Professor of Neurology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Sclerosis</mesh_term>
      <mesh_term>Neuromyelitis Optica</mesh_term>
      <mesh_term>Demyelinating Diseases</mesh_term>
      <mesh_term>Demyelinating Autoimmune Diseases, CNS</mesh_term>
      <mesh_term>Autoimmune Diseases</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Beginning 3 months and ending 5 years following article publication.</ipd_time_frame>
      <ipd_access_criteria>Researchers who provide a methodologically sound proposal. Any purpose. Specify Other Mechanism Proposals should be directed to erin.beck@mssm.edu To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05982925
  org study id: STUDY-21-01855
  nct id: NCT05982925
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  In this protocol, a combination of MRI, blood, and cerebrospinal fluid (CSF) analysis will be
        used to understand the natural history, underlying immunologic mechanisms, and clinical
        implications of central nervous system (CNS) lesions, in particular lesions in the cerebral
        cortex, in multiple sclerosis (MS) and other inflammatory and autoimmune disorders affecting
        the CNS. Patients with these disorders, as well as healthy controls, will undergo baseline
        clinical evaluation and testing, bloodwork, and MRI, with follow up clinical evaluation,
        bloodwork, and MRI at years 1, 3, and 6. Additional MRIs may be performed in patients with
        possible new lesion formation or to compare MRI techniques. Lumbar puncture will be performed
        on participants who are not currently being treated with disease modifying therapies and who
        are willing to undergo the procedure.
  observational model: Cohort
  time perspective: Prospective
  measure: Cortical Lesion Number
  time frame: at 6 years (end of study)
  description: Lesions in the cerebral cortex
  arm group label: MS Participant
  description: Adults with multiple sclerosis
  arm group label: Control Participant
  description: Adults without neurologic disease
  arm group label: Other Neuroinflammatory Participants
  description: Adults with a neuroinflammatory disease that is not multiple sclerosis
  Blood and cerebrospinal fluid
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Erin S Beck, MD, PhD
  role: Principal Investigator
  affiliation: Icahn School of Medicine at Mount Sinai
  last name: Erin S Beck, MD, PhD
  phone: 212-241-2474
  email: erin.beck@mssm.edu
  last name: Julia L Galasso, BS
  phone: 212-241-9463
  email: julia.galasso@mssm.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Icahn School of Medicine at Mount Sinai
  investigator full name: Erin Beck
  investigator title: Assistant Professor of Neurology
  mesh term: Multiple Sclerosis
  mesh term: Neuromyelitis Optica
  mesh term: Demyelinating Diseases
  mesh term: Demyelinating Autoimmune Diseases, CNS
  mesh term: Autoimmune Diseases
  mesh term: Sclerosis
  sharing ipd: Yes
  ipd description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Beginning 3 months and ending 5 years following article publication.
  ipd access criteria: Researchers who provide a methodologically sound proposal. Any purpose. Specify Other Mechanism Proposals should be directed to erin.beck@mssm.edu To gain access, data requestors will need to sign a data access agreement.