<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/NCT04448977</url>
  </required_header>
  <id_info>
    <org_study_id>R-1104-20</org_study_id>
    <nct_id>NCT04448977</nct_id>
  </id_info>
  <brief_title>Examining Effects of Ocrevus on Cognitive Fatigue Using fMRI</brief_title>
  <official_title>A Biomarker for Cognitive Fatigue Using Functional Imaging in MS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kessler Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hackensack Meridian Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kessler Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to investigate the effectiveness of MS Disease&#xD;
      modifying medications on cognitive fatigue in persons with relapsing remitting multiple&#xD;
      sclerosis (RRMS). Cognitive fatigue is the kind of fatigue that occurs after intense mental&#xD;
      concentration as after a session of problem solving.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The researchers aim is to investigate the effects of disease modifying treatments on&#xD;
      cognitive fatigue and on specific brain areas that have been shown to underlie cognitive&#xD;
      fatigue in individuals with Multiple Sclerosis (MS). The researchers will investigate the&#xD;
      effects on the cognitive fatigue that develops during the performance of a demanding task,&#xD;
      and also on how cognitive fatigue changes as a function of duration of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 6, 2021</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</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>Brain activation (BOLD signal)</measure>
    <time_frame>Measured for change at 3 time points (before, six months and 12 months after intervention)</time_frame>
    <description>A change in brain activation as measured with functional magnetic resonance imaging through blood oxygen level dependent signal will be measured in association with cognitive fatigue (as measured by the Visual Analogue scale during performance of the modified Symbol Digit Modality and Modified Fatigue Impact Scale).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fatigue onset</measure>
    <time_frame>Measured for change at 3 time points for change (before, six months and 12 months after intervention)</time_frame>
    <description>A change in the speed with which modified Symbol Digit Modality task (a cognitively demanding task) induces fatigue in MS (as measured by the Visual Analogue scale and Modified Fatigue Impact Scale).</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Multiple Sclerosis, Relapsing-Remitting</condition>
  <arm_group>
    <arm_group_label>Multiple Sclerosis group 1</arm_group_label>
    <description>Individuals with Multiple Sclerosis who are going to be starting Ocrevus as determined by Neurologist as part of clinical care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Sclerosis group 2</arm_group_label>
    <description>Individuals with Multiple Sclerosis who are going to be starting Copaxone as determined by Neurologist as part of clinical care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <description>Healthy individuals who are age, gender and education matched to the other groups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ocrevus</intervention_name>
    <description>Participants with MS will be divided into two treatment groups: those who will begin to take Ocrevus (the &quot;early Ocrevus&quot; group (EO), and those who plan to be begin treatment with Glatimer acetate SC (Copaxone) (EC). Both groups will be matched to the EO group for age, gender and education. The HC group will be free of neurological disease or injury and will be matched to the EO group for age, gender, and education.</description>
    <arm_group_label>Multiple Sclerosis group 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals who have Relapsing remitting Multiple Sclerosis and Healthy Volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18-64.&#xD;
&#xD;
          -  Relapsing remitting multiple sclerosis&#xD;
&#xD;
          -  Been newly prescribed a new disease modifying medication for MS (either Ocrevus or&#xD;
             Copaxone)&#xD;
&#xD;
          -  or healthy volunteer who can speak English fluently.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of head injury, stroke, seizures, or any other significant neurological event&#xD;
             other than MS&#xD;
&#xD;
          -  Flare up of MS symptoms within the past month.&#xD;
&#xD;
          -  History of significant psychiatric illness (for example, bipolar disorder,&#xD;
             schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder.&#xD;
&#xD;
          -  Pacemaker or other implanted electrical device, brain stimulator, aneurysm clip (metal&#xD;
             clips on the wall of a large artery), metallic prostheses (including metal pins and&#xD;
             rods, heart valves, and internal hearing aids [cochlear implants]), permanent&#xD;
             eyeliner, implanted delivery pumps, or shrapnel fragments.&#xD;
&#xD;
          -  left handed.&#xD;
&#xD;
          -  Not able to have an MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John DeLuca, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kessler Foundation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nancy Moore, M.A.</last_name>
    <phone>973-324-8450</phone>
    <email>nbmoore@kesslerfoundation.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Angela Smith, M.A.</last_name>
    <phone>973-324-8448</phone>
    <email>asmith@kesslerfoundation.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kessler Foundation</name>
      <address>
        <city>West Orange</city>
        <state>New Jersey</state>
        <zip>07052</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nancy B Moore, MA</last_name>
      <phone>973-324-8450</phone>
      <email>nbmoore@kesslerfoundation.org</email>
    </contact>
    <contact_backup>
      <last_name>Angela Smith, M.A.</last_name>
      <phone>973-324-8448</phone>
      <email>asmith@kesslerfoundation.org</email>
    </contact_backup>
    <investigator>
      <last_name>John DeLuca, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ekaterina Dobryakova, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Helen Genova, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Glenn Wylie, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Krupa Pandey, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Florian Thomas, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>October 12, 2022</last_update_submitted>
  <last_update_submitted_qc>October 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>cognitive fatigue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Multiple Sclerosis, Relapsing-Remitting</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ocrelizumab</mesh_term>
  </intervention_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/NCT04448977
org study id: R-1104-20
nct id: NCT04448977
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this research study is to investigate the effectiveness of MS Disease
      modifying medications on cognitive fatigue in persons with relapsing remitting multiple
      sclerosis (RRMS). Cognitive fatigue is the kind of fatigue that occurs after intense mental
      concentration as after a session of problem solving.
The researchers aim is to investigate the effects of disease modifying treatments on
      cognitive fatigue and on specific brain areas that have been shown to underlie cognitive
      fatigue in individuals with Multiple Sclerosis (MS). The researchers will investigate the
      effects on the cognitive fatigue that develops during the performance of a demanding task,
      and also on how cognitive fatigue changes as a function of duration of treatment.
observational model: Case-Control
time perspective: Prospective
measure: Brain activation (BOLD signal)
time frame: Measured for change at 3 time points (before, six months and 12 months after intervention)
description: A change in brain activation as measured with functional magnetic resonance imaging through blood oxygen level dependent signal will be measured in association with cognitive fatigue (as measured by the Visual Analogue scale during performance of the modified Symbol Digit Modality and Modified Fatigue Impact Scale).
measure: Fatigue onset
time frame: Measured for change at 3 time points for change (before, six months and 12 months after intervention)
description: A change in the speed with which modified Symbol Digit Modality task (a cognitively demanding task) induces fatigue in MS (as measured by the Visual Analogue scale and Modified Fatigue Impact Scale).
arm group label: Multiple Sclerosis group 1
description: Individuals with Multiple Sclerosis who are going to be starting Ocrevus as determined by Neurologist as part of clinical care.
arm group label: Multiple Sclerosis group 2
description: Individuals with Multiple Sclerosis who are going to be starting Copaxone as determined by Neurologist as part of clinical care.
arm group label: Healthy Controls
description: Healthy individuals who are age, gender and education matched to the other groups.
intervention type: Drug
intervention name: Ocrevus
description: Participants with MS will be divided into two treatment groups: those who will begin to take Ocrevus (the "early Ocrevus" group (EO), and those who plan to be begin treatment with Glatimer acetate SC (Copaxone) (EC). Both groups will be matched to the EO group for age, gender and education. The HC group will be free of neurological disease or injury and will be matched to the EO group for age, gender, and education.
arm group label: Multiple Sclerosis group 1
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John DeLuca, PhD
role: Principal Investigator
affiliation: Kessler Foundation
last name: Nancy Moore, M.A.
phone: 973-324-8450
email: nbmoore@kesslerfoundation.org
last name: Angela Smith, M.A.
phone: 973-324-8448
email: asmith@kesslerfoundation.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Sclerosis
mesh term: Fatigue
mesh term: Ocrelizumab
sharing ipd: No