<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/NCT03838770</url>
  </required_header>
  <id_info>
    <org_study_id>18-01406</org_study_id>
    <nct_id>NCT03838770</nct_id>
  </id_info>
  <brief_title>tDCS for the Management of Multiple Sclerosis Related Fatigue</brief_title>
  <official_title>Transcranial Direct Current Stimulation (tDCS) for the Management of Multiple Sclerosis Related Fatigue</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Multiple Sclerosis Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</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>
      This is a pragmatic clinical trial that aims to determine the effect of tDCS on symptomatic&#xD;
      fatigue in Multiple Sclerosis (MS) patients. This is a randomized, blinded, sham-controlled&#xD;
      study design to determine the effect of Transcranial Direct Current Stimulation (tDCS) on MS&#xD;
      participants to reduce feelings of fatigue.120 participants with MS and&#xD;
      clinically-significant fatigue (as defined by a score of &gt;36 on the Fatigue Severity Scale)&#xD;
      will be recruited to participate in either an active or sham treatment condition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2019</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change from baseline in the self-reported Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue instrument.</measure>
    <time_frame>7 Days post end of Treatment</time_frame>
    <description>The minimally important difference representing a clinically significant improvement in patient-reported fatigue on the 7-item PROMIS Fatigue Scale is defined as a 3.0 point change in raw score. Clinically-significant response to tDCS treatment by the conservative measurement of &gt;3.0 points on the PROMIS Fatigue Scale.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active tDCS</intervention_name>
    <description>Active target 2.0mA tDCS (n=60)</description>
    <arm_group_label>Active</arm_group_label>
    <other_name>Soterix Mini-Ct Device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham tDCS</intervention_name>
    <description>sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage</description>
    <arm_group_label>Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Definite MS diagnosis, all subtypes&#xD;
&#xD;
          -  Fatigue Severity Scale score of 36 or greater&#xD;
&#xD;
          -  Score of 7.5 or less on the Expanded Disability Status Scale (EDSS) (with caregiver&#xD;
             proxy required for those with scores of 7.5 or greater)&#xD;
&#xD;
          -  Ability to understand the informed consent process and provide consent to participate&#xD;
             in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary neurologic, psychiatric or other medical disorder other than MS&#xD;
&#xD;
          -  History of seizures or seizure disorder&#xD;
&#xD;
          -  History of head trauma or medical device in head or neck&#xD;
&#xD;
          -  Clinically significant abnormality on EKG&#xD;
&#xD;
          -  Current symptomatic treatment for fatigue&#xD;
&#xD;
          -  Symbol Digit Modalities Test or SDMT score≥3.0 SD from published norms&#xD;
&#xD;
          -  WRAT-4 reading level below average (&lt;85) (estimated general intellectual function)&#xD;
&#xD;
          -  Beck Depression Inventory-Fast Screen (BDI- FS) score ≥10&#xD;
&#xD;
          -  Current chronic headaches or migraines&#xD;
&#xD;
          -  Skin disorder/sensitive near stimulation locations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leigh Charvet, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York Langone Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>December 1, 2021</last_update_submitted>
  <last_update_submitted_qc>December 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2021</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>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>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 36 months following article publication.</ipd_time_frame>
    <ipd_access_criteria>For individual participant data meta-analysis. Investigators whose proposed use of the data has been approved by an independent review committee (&quot;learned intermediary&quot;) identified for this purpose.</ipd_access_criteria>
  </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/NCT03838770
org study id: 18-01406
nct id: NCT03838770
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a pragmatic clinical trial that aims to determine the effect of tDCS on symptomatic
      fatigue in Multiple Sclerosis (MS) patients. This is a randomized, blinded, sham-controlled
      study design to determine the effect of Transcranial Direct Current Stimulation (tDCS) on MS
      participants to reduce feelings of fatigue.120 participants with MS and
      clinically-significant fatigue (as defined by a score of >36 on the Fatigue Severity Scale)
      will be recruited to participate in either an active or sham treatment condition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: change from baseline in the self-reported Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue instrument.
time frame: 7 Days post end of Treatment
description: The minimally important difference representing a clinically significant improvement in patient-reported fatigue on the 7-item PROMIS Fatigue Scale is defined as a 3.0 point change in raw score. Clinically-significant response to tDCS treatment by the conservative measurement of >3.0 points on the PROMIS Fatigue Scale.
arm group label: Active
arm group type: Experimental
arm group label: Sham
arm group type: Placebo Comparator
intervention type: Device
intervention name: Active tDCS
description: Active target 2.0mA tDCS (n=60)
arm group label: Active
other name: Soterix Mini-Ct Device
intervention type: Device
intervention name: sham tDCS
description: sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage
arm group label: Sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Leigh Charvet, MD
role: Principal Investigator
affiliation: New York Langone Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
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: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 9 months and ending 36 months following article publication.
ipd access criteria: For individual participant data meta-analysis. Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.