<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/NCT04466228</url>
  </required_header>
  <id_info>
    <org_study_id>FG-1908-34831</org_study_id>
    <nct_id>NCT04466228</nct_id>
  </id_info>
  <brief_title>Non-invasive Transcranial Electrical Stimulation in MS</brief_title>
  <official_title>Effects of Non-invasive Transcranial Electrical Stimulation on Cognition in Patients With Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal is to investigate the effects of non-invasive transcranial electrical stimulation on&#xD;
      cognition in MS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants' baseline cognitive function will be assessed with a tablet-based,&#xD;
      videogame-like software specifically designed as a medical device to test and train cognitive&#xD;
      function for populations with cognitive disorders. After baseline test assessment,&#xD;
      participants will receive stimulation while playing the training version of the software.&#xD;
      After the stimulation, cognitive performance will be evaluated again with the testing&#xD;
      version. Investigators will assess changes in cognitive performance associated with&#xD;
      stimulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2020</start_date>
  <completion_date type="Actual">August 23, 2022</completion_date>
  <primary_completion_date type="Actual">August 23, 2022</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Processing speed change from baseline assessment</measure>
    <time_frame>Baseline and post-stimulation, up to 2 hours</time_frame>
    <description>Symbol Digit Modalities Test (SDMT) score will be used to measure processing speed. SDMT measures the time to pair abstract symbols with specific numbers. The test requires visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items in 90 seconds. (max=110, min=0). Higher scores indicate improvement. Lower scores indicate worsening.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EVO performance change from baseline assessment</measure>
    <time_frame>Baseline and post-stimulation, up to 2 hours</time_frame>
    <description>EVO tool is a digital cognitive assessment developed to assess cognitive function including attention and related cognitive control processes in clinical populations. It comes with the closed-loop adaptive algorithm which makes proportional changes in gameplay difficulty when the participant's performance deviates from an 80% rate of accuracy, which ensures that task difficulty is equated across participants and enhances engagement. Gameplay threshold (level 0 to level 20), response time and response time variability will be measured to evaluate attention control. Higher threshold level, lower response time and smaller response time variability indicate improvement.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Multiple Sclerosis</condition>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Stim1 high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive high dose non-invasive transcranial electrical stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stim2 low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive low dose non-invasive transcranial electrical stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>This group will receive sham control non-invasive transcranial electrical stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>non-invasive transcranial electrical stimulation</intervention_name>
    <description>Non-invasive transcranial electrical stimulation across the prefrontal cortex.</description>
    <arm_group_label>Sham control</arm_group_label>
    <arm_group_label>Stim1 high dose</arm_group_label>
    <arm_group_label>Stim2 low dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18-65,&#xD;
&#xD;
          -  diagnosis of MS&#xD;
&#xD;
          -  Expanded Disability Status Scale (EDSS)≤6.5, no paresis of the upper limbs&#xD;
&#xD;
          -  a minimum of 3 months since the last relapse&#xD;
&#xD;
          -  Beck Depression Inventory&lt;19&#xD;
&#xD;
          -  normal hearing&#xD;
&#xD;
          -  and no changes in MS or symptomatic medications in past 2 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prior brain surgery&#xD;
&#xD;
          -  clips in brain&#xD;
&#xD;
          -  epilepsy or other neurological or non-affective psychiatric disorders&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Riley Bove, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSF Sandler Neurosciences Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>December 1, 2022</last_update_submitted>
  <last_update_submitted_qc>December 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 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>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 22, 2023</submitted>
    <returned>September 15, 2023</returned>
  </pending_results>
  <!-- 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/NCT04466228
org study id: FG-1908-34831
nct id: NCT04466228
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The goal is to investigate the effects of non-invasive transcranial electrical stimulation on
      cognition in MS.
The participants' baseline cognitive function will be assessed with a tablet-based,
      videogame-like software specifically designed as a medical device to test and train cognitive
      function for populations with cognitive disorders. After baseline test assessment,
      participants will receive stimulation while playing the training version of the software.
      After the stimulation, cognitive performance will be evaluated again with the testing
      version. Investigators will assess changes in cognitive performance associated with
      stimulation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Processing speed change from baseline assessment
time frame: Baseline and post-stimulation, up to 2 hours
description: Symbol Digit Modalities Test (SDMT) score will be used to measure processing speed. SDMT measures the time to pair abstract symbols with specific numbers. The test requires visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items in 90 seconds. (max=110, min=0). Higher scores indicate improvement. Lower scores indicate worsening.
measure: EVO performance change from baseline assessment
time frame: Baseline and post-stimulation, up to 2 hours
description: EVO tool is a digital cognitive assessment developed to assess cognitive function including attention and related cognitive control processes in clinical populations. It comes with the closed-loop adaptive algorithm which makes proportional changes in gameplay difficulty when the participant's performance deviates from an 80% rate of accuracy, which ensures that task difficulty is equated across participants and enhances engagement. Gameplay threshold (level 0 to level 20), response time and response time variability will be measured to evaluate attention control. Higher threshold level, lower response time and smaller response time variability indicate improvement.
arm group label: Stim1 high dose
arm group type: Experimental
description: This group will receive high dose non-invasive transcranial electrical stimulation
arm group label: Stim2 low dose
arm group type: Experimental
description: This group will receive low dose non-invasive transcranial electrical stimulation
arm group label: Sham control
arm group type: Sham Comparator
description: This group will receive sham control non-invasive transcranial electrical stimulation
intervention type: Device
intervention name: non-invasive transcranial electrical stimulation
description: Non-invasive transcranial electrical stimulation across the prefrontal cortex.
arm group label: Sham control
arm group label: Stim1 high dose
arm group label: Stim2 low dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Riley Bove, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No
submitted: August 22, 2023
returned: September 15, 2023