<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/NCT03272906</url>
  </required_header>
  <id_info>
    <org_study_id>LEQSF(2017-20)-RD-A-03</org_study_id>
    <nct_id>NCT03272906</nct_id>
  </id_info>
  <brief_title>Clinical Feasibility of Transcranial Direct Current Stimulation [tDCS] With Standard Aphasia Therapy</brief_title>
  <official_title>Clinical Feasibility of Transcranial Direct Current Stimulation [tDCS] With Standard Aphasia Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Louisiana State University and A&amp;M College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Louisiana State University and A&amp;M College</source>
  <oversight_info>
    <has_dmc>No</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study Design: This is a within-subjects crossover design. Subjects will participate in the&#xD;
      procedures twice, once under each condition (active vs. sham stimulation). The order of&#xD;
      conditions will be counter-balanced across subjects. Stimulation will target ventral inferior&#xD;
      frontal gyrus (IFG) and will be paired with standard speech-language therapy. Outcome&#xD;
      measures will be acquired at the beginning and end of a semester of standard speech-language&#xD;
      therapy, and at follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Baseline Behavioral Assessment: Medical and neurological history will be taken. Western&#xD;
      Aphasia Battery-Revised, Communication Activities of Daily Living-2, and Philadelphia Naming&#xD;
      Test (short form) will be administered. Narrative will be elicited (Cinderella story). Some&#xD;
      of these procedures will be videorecorded for later transcription. Subjects will also&#xD;
      complete a pre-tDCS safety screening questionnaire.&#xD;
&#xD;
      tDCS: Participants will undergo placement of 2 tDCS electrodes. For all subjects, the anodal&#xD;
      electrode will be placed at the following locations (EEG 10-20 system):&#xD;
&#xD;
      (i) over the left inferior frontal gyrus (crossing point between T3-Fz and F7-Cz)&#xD;
&#xD;
      The cathodal electrode will be placed at the second site:&#xD;
&#xD;
      (ii) over right frontal pole (Fp2)&#xD;
&#xD;
      Two types of stimulation will be given, an active condition and a sham condition. In the sham&#xD;
      condition, stimulation is ramped up over the first 30 seconds (as in the active condition),&#xD;
      but then discontinued. This gives the physical perception of stimulation without the&#xD;
      modulatory effects.&#xD;
&#xD;
      Stimulation will be delivered by a tDCS device with the following parameters for intensity&#xD;
      and duration:&#xD;
&#xD;
        -  Intensity: 2 mA&#xD;
&#xD;
        -  Duration: 20 minutes&#xD;
&#xD;
      tDCS will be provided for the first 20 minutes of each aphasia therapy session provided at&#xD;
      the LSU Speech-Language-Hearing Clinic. The therapy sessions last for one hour and are&#xD;
      provided twice weekly for 12 weeks over the course of an academic semester (fall and spring).&#xD;
&#xD;
      Post-Therapy/Stimulation Assessment: Western Aphasia Battery-Revised, Communication&#xD;
      Activities of Daily Living-2, and Philadelphia Naming Test (short form) will be administered&#xD;
      as before therapy. Cinderella narrative will again be elicited. Some of these procedures will&#xD;
      again be videorecorded for later transcription. A tDCS sensations survey will also be&#xD;
      completed at the final assessment to determine the effectiveness of blinding.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 31, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Production of Correct Information Units (CIUs) in Cinderella narrative</measure>
    <time_frame>Following 12 weeks of speech-language therapy and at 6-week follow up</time_frame>
    <description>Change in CIU production over treatment interval. Words are counted as CIUs if they are novel, intelligible, and appropriate in context</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Western Aphasia Battery-Revised (WAB-R)</measure>
    <time_frame>Following 12 weeks of speech-language therapy and at 6-week follow up</time_frame>
    <description>Change in performance on Part 1 of WAB-R (Aphasia Quotient)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Communication Activities of Daily Living-2 (CADL-2)</measure>
    <time_frame>Following 12 weeks of speech-language therapy and at 6-week follow up</time_frame>
    <description>Change in performance on CADL-2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Philadelphia Naming Test - Short Form (PNT)</measure>
    <time_frame>Following 12 weeks of speech-language therapy and at 6-week follow up</time_frame>
    <description>Change in performance on PNT</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Aphasia</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>A-tDCS &amp; speech-language therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anodal transcranial direct current stimulation (2 mA) plus speech-language therapy for 24 sessions (20-minutes per each 60-minute treatment session) over the course of 12 weeks. The electrical current will be administered over ventral inferior frontal gyrus. The stimulation will be delivered at an intensity of 2mA for a maximum of 20 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham-tDCS &amp; speech-language therapy</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham transcranial direct current stimulation (2 mA) plus speech-language therapy for 24 sessions (20-minutes per each 60-minute treatment session) over the course of 12 weeks. Electrodes will be placed as in A-tDCS. Current will be ramped up for the first 30 seconds following which the intensity will drop to 0 mA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Anodal transcranial direct current stimulation</intervention_name>
    <description>2 mA of A-tDCS stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 2 mA occurs over 30 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 60-minute treatment session.</description>
    <arm_group_label>A-tDCS &amp; speech-language therapy</arm_group_label>
    <other_name>(A-tDCS)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham transcranial direct current stimulation</intervention_name>
    <description>2 mA of A-tDCS stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 2 mA occurs over 30 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition.</description>
    <arm_group_label>Sham-tDCS &amp; speech-language therapy</arm_group_label>
    <other_name>Sham</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Speech-language therapy</intervention_name>
    <description>Therapy tasks will be determined by the clinician on an individualized basis and will not be affected by this research protocol. The only difference between the clinical therapy that is normally provided in the clinic and this research paradigm is the application of tDCS electrodes during therapy. Therapist is blinded to stimulation type.</description>
    <arm_group_label>A-tDCS &amp; speech-language therapy</arm_group_label>
    <arm_group_label>Sham-tDCS &amp; speech-language therapy</arm_group_label>
    <other_name>SLT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Single, unilateral stroke resulting in aphasia&#xD;
&#xD;
          -  Competency to provide written informed consent&#xD;
&#xD;
          -  Ability to participate in standard aphasia therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious psychological condition&#xD;
&#xD;
          -  Serious neurological condition, other than stroke&#xD;
&#xD;
          -  Serious medical condition&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  History of seizures&#xD;
&#xD;
          -  Presence of electronic or metal implants (e.g., pacemaker, vagal nerve stimulator,&#xD;
             etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>E. Susan Duncan, PhD, CCC-SLP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lousiana State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Louisiana State University</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 2, 2017</study_first_submitted>
  <study_first_submitted_qc>September 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>March 7, 2023</last_update_submitted>
  <last_update_submitted_qc>March 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Louisiana State University and A&amp;M College</investigator_affiliation>
    <investigator_full_name>E. Susan Duncan</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>aphasia</keyword>
  <keyword>stroke</keyword>
  <keyword>tDCS</keyword>
  <keyword>language</keyword>
  <keyword>stimulation</keyword>
  <keyword>brain</keyword>
  <keyword>speech therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aphasia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03272906
org study id: LEQSF(2017-20)-RD-A-03
nct id: NCT03272906
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
Study Design: This is a within-subjects crossover design. Subjects will participate in the
      procedures twice, once under each condition (active vs. sham stimulation). The order of
      conditions will be counter-balanced across subjects. Stimulation will target ventral inferior
      frontal gyrus (IFG) and will be paired with standard speech-language therapy. Outcome
      measures will be acquired at the beginning and end of a semester of standard speech-language
      therapy, and at follow-up.
Baseline Behavioral Assessment: Medical and neurological history will be taken. Western
      Aphasia Battery-Revised, Communication Activities of Daily Living-2, and Philadelphia Naming
      Test (short form) will be administered. Narrative will be elicited (Cinderella story). Some
      of these procedures will be videorecorded for later transcription. Subjects will also
      complete a pre-tDCS safety screening questionnaire.

      tDCS: Participants will undergo placement of 2 tDCS electrodes. For all subjects, the anodal
      electrode will be placed at the following locations (EEG 10-20 system):

      (i) over the left inferior frontal gyrus (crossing point between T3-Fz and F7-Cz)

      The cathodal electrode will be placed at the second site:

      (ii) over right frontal pole (Fp2)

      Two types of stimulation will be given, an active condition and a sham condition. In the sham
      condition, stimulation is ramped up over the first 30 seconds (as in the active condition),
      but then discontinued. This gives the physical perception of stimulation without the
      modulatory effects.

      Stimulation will be delivered by a tDCS device with the following parameters for intensity
      and duration:

        -  Intensity: 2 mA

        -  Duration: 20 minutes

      tDCS will be provided for the first 20 minutes of each aphasia therapy session provided at
      the LSU Speech-Language-Hearing Clinic. The therapy sessions last for one hour and are
      provided twice weekly for 12 weeks over the course of an academic semester (fall and spring).

      Post-Therapy/Stimulation Assessment: Western Aphasia Battery-Revised, Communication
      Activities of Daily Living-2, and Philadelphia Naming Test (short form) will be administered
      as before therapy. Cinderella narrative will again be elicited. Some of these procedures will
      again be videorecorded for later transcription. A tDCS sensations survey will also be
      completed at the final assessment to determine the effectiveness of blinding.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Production of Correct Information Units (CIUs) in Cinderella narrative
time frame: Following 12 weeks of speech-language therapy and at 6-week follow up
description: Change in CIU production over treatment interval. Words are counted as CIUs if they are novel, intelligible, and appropriate in context
measure: Western Aphasia Battery-Revised (WAB-R)
time frame: Following 12 weeks of speech-language therapy and at 6-week follow up
description: Change in performance on Part 1 of WAB-R (Aphasia Quotient)
measure: Communication Activities of Daily Living-2 (CADL-2)
time frame: Following 12 weeks of speech-language therapy and at 6-week follow up
description: Change in performance on CADL-2
measure: Philadelphia Naming Test - Short Form (PNT)
time frame: Following 12 weeks of speech-language therapy and at 6-week follow up
description: Change in performance on PNT
arm group label: A-tDCS & speech-language therapy
arm group type: Experimental
description: Anodal transcranial direct current stimulation (2 mA) plus speech-language therapy for 24 sessions (20-minutes per each 60-minute treatment session) over the course of 12 weeks. The electrical current will be administered over ventral inferior frontal gyrus. The stimulation will be delivered at an intensity of 2mA for a maximum of 20 minutes.
arm group label: Sham-tDCS & speech-language therapy
arm group type: Sham Comparator
description: Sham transcranial direct current stimulation (2 mA) plus speech-language therapy for 24 sessions (20-minutes per each 60-minute treatment session) over the course of 12 weeks. Electrodes will be placed as in A-tDCS. Current will be ramped up for the first 30 seconds following which the intensity will drop to 0 mA.
intervention type: Device
intervention name: Anodal transcranial direct current stimulation
description: 2 mA of A-tDCS stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 2 mA occurs over 30 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 60-minute treatment session.
arm group label: A-tDCS & speech-language therapy
other name: (A-tDCS)
intervention type: Device
intervention name: Sham transcranial direct current stimulation
description: 2 mA of A-tDCS stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 2 mA occurs over 30 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition.
arm group label: Sham-tDCS & speech-language therapy
other name: Sham
intervention type: Behavioral
intervention name: Speech-language therapy
description: Therapy tasks will be determined by the clinician on an individualized basis and will not be affected by this research protocol. The only difference between the clinical therapy that is normally provided in the clinic and this research paradigm is the application of tDCS electrodes during therapy. Therapist is blinded to stimulation type.
arm group label: A-tDCS & speech-language therapy
arm group label: Sham-tDCS & speech-language therapy
other name: SLT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: E. Susan Duncan, PhD, CCC-SLP
role: Principal Investigator
affiliation: Lousiana State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Louisiana State University and A&M College
investigator full name: E. Susan Duncan
investigator title: Assistant Professor
mesh term: Aphasia