<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/NCT04432883</url>
  </required_header>
  <id_info>
    <org_study_id>UNM HRRC #16-091</org_study_id>
    <secondary_id>1P20GM109089-01A1</secondary_id>
    <secondary_id>R01DC018282</secondary_id>
    <nct_id>NCT04432883</nct_id>
  </id_info>
  <brief_title>Targeted TDCS to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia.</brief_title>
  <acronym>AphasiatDCS</acronym>
  <official_title>Targeted Transcranial Direct Current Stimulation to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of General Medical Sciences (NIGMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Deafness and Other Communication Disorders (NIDCD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of New Mexico</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>
      62 patients who are one year post stroke and have Aphasia as a result of that stroke will be&#xD;
      recruited. Participants will have 4 assessment sessions and 15 treatment sessions. The TDCS&#xD;
      will be to right Inferior Frontal Gyrus (IFG) (25 active, 25 sham) for 15 days. A combined&#xD;
      semantic feature analysis/phonological components analysis treatment will be paired with the&#xD;
      stimulation. Two assessment sessions will be pretreatment, 1 session immediately&#xD;
      post-treatment, and 1 session at 3 months follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our long-term goal is to develop safe and effective treatments for the communication problems&#xD;
      of Aphasia due to stroke that restore patients to higher levels of functioning, decrease&#xD;
      disability, and promote higher quality of life. While language therapy for aphasia is&#xD;
      effective, improvements are typically slow, and gains may be small. Noninvasive brain&#xD;
      stimulation has been suggested as a method to enhance outcomes from language therapy. This&#xD;
      study will examine whether outcomes for language therapy with brain stimulation are different&#xD;
      from outcomes for language therapy without brain stimulation in people with aphasia. Our&#xD;
      central hypotheses are (1) targeted right hemisphere HDtDCS (RH-HD-tDCS) administered in&#xD;
      combination with language treatment will result in greater changes in naming accuracy than&#xD;
      language treatment with the sham RH-HD-tDCS (2) RH-HD-tDCS plus language treatment will&#xD;
      result in greater increases in communication within the affected hemisphere compared to&#xD;
      language treatment plus sham RH-HD-tDCS (3) RH-HD-tDCS plus language treatment will result in&#xD;
      greater increases in perilesional areas working together immediately post-treatment compared&#xD;
      to language treatment plus sham RH-HD-tDCS&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 18, 2022</start_date>
  <completion_date type="Anticipated">April 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 8, 2025</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Picture Naming of trained items</measure>
    <time_frame>3 months</time_frame>
    <description>Change in naming of pictures of trained items; 60 pictured items; higher score indicates improvement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Naming Response Time of trained items Scales - IV (WAIS-IV; Wechsler, Coalson, &amp; Railford, 2008)</measure>
    <time_frame>3 months</time_frame>
    <description>Change in response time of naming of pictures of trained items; 0-20 seconds, decreased response time indicates improvement Scales - IV (WAIS-IV; Wechsler, Coalson, &amp; Railford, 2008)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Naming Efficiency of trained items</measure>
    <time_frame>3 months</time_frame>
    <description>Change in efficiency of naming of pictures of trained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Discourse informativeness - Main Concept Production</measure>
    <time_frame>3 months</time_frame>
    <description>Change in discourse informativeness as measured by main concept scores; increased values indicate improvement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficiency of discourse informativeness - Main Concept Production</measure>
    <time_frame>3 months</time_frame>
    <description>Change in efficiency of discourse informativeness; accurate and complete main concepts produced over the time of discourse elicitation (ACs/min); larger numbers indicate greater efficiency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Picture Naming of untrained items - Boston Naming Test</measure>
    <time_frame>3 months</time_frame>
    <description>Change in naming of pictures of untrained items; 60 pictured items; higher score indicates improvement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Naming Response Time of untrained items - Boston Naming Test</measure>
    <time_frame>3 months</time_frame>
    <description>Change in response time of naming of pictures of untrained items; 0-20 seconds, decreased response time indicates improvement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Naming Efficiency of untrained items - Boston Naming Test</measure>
    <time_frame>3 months</time_frame>
    <description>Change in efficiency of naming of pictures of untrained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Stroke</condition>
  <condition>Aphasia</condition>
  <arm_group>
    <arm_group_label>Experimental: Active cathodal tDCS + Speech-language training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of active tDCS (x 30 minutes of stimulation) combined with 1 hour simultaneous speech-language training on consecutive weekdays.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator: Placebo cathodal tDCS + Speech-language training</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of sham tDCS (x 30 minutes sham) combined with 1 hour simultaneous speech-language training on consecutive weekdays..</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active Comparator: Experimental: Active cathodal tDCS + language training</intervention_name>
    <description>Cathodal tDCS raises neuronal membrane potentials, leading to decreased probability of depolarization from incoming stimuli.&#xD;
Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment.</description>
    <arm_group_label>Experimental: Active cathodal tDCS + Speech-language training</arm_group_label>
    <other_name>Behavioral: Speech and Language Training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sham Comparator: Placebo cathodal tDCS + Speech and language</intervention_name>
    <description>Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment. .</description>
    <arm_group_label>Comparator: Placebo cathodal tDCS + Speech-language training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. aged 25-85&#xD;
&#xD;
          2. must be greater than 1 year post-stroke&#xD;
&#xD;
          3. must have a diagnosis of aphasia based on impaired performance on the Western Aphasia&#xD;
             Battery-Revised, Boston Naming Test, or during discourse production&#xD;
&#xD;
          4. must be left-hemisphere dominant as demonstrated by aphasia onset subsequent to left&#xD;
             hemisphere damage&#xD;
&#xD;
          5. must be stimulable for naming&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. comorbid neurological disease.&#xD;
&#xD;
          2. damage to the anterior right hemisphere.&#xD;
&#xD;
          3. significant mood disorder.&#xD;
&#xD;
          4. substance/alcohol dependence or abuse within the past year&#xD;
&#xD;
          5. presence of any implanted electrical device or contraindications to tDCS or MRI&#xD;
&#xD;
          6. recent medical instability (within 4 weeks)&#xD;
&#xD;
          7. pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jessica Richardson, Ph.D.</last_name>
    <phone>505 277-1765</phone>
    <email>jdrichardson@unm.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Honey Hubbard</last_name>
    <phone>505-433-7766</phone>
    <email>hhubbard@unm.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of New Mexico Center for Brain Recovery and Repair</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Darbi Gill</last_name>
      <phone>505-925-4043</phone>
      <email>DMGill@salud.unm.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 3, 2019</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>May 1, 2023</last_update_submitted>
  <last_update_submitted_qc>May 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of New Mexico</investigator_affiliation>
    <investigator_full_name>Jessica Richardson</investigator_full_name>
    <investigator_title>Assistant Professor: SOM Neurosurgery</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Aphasia</keyword>
  <keyword>brain stimulation</keyword>
  <keyword>communication problems</keyword>
  <keyword>speech and language therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Aphasia</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 12, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT04432883/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04432883
org study id: UNM HRRC #16-091
secondary id: 1P20GM109089-01A1
secondary id: R01DC018282
nct id: NCT04432883
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
62 patients who are one year post stroke and have Aphasia as a result of that stroke will be
      recruited. Participants will have 4 assessment sessions and 15 treatment sessions. The TDCS
      will be to right Inferior Frontal Gyrus (IFG) (25 active, 25 sham) for 15 days. A combined
      semantic feature analysis/phonological components analysis treatment will be paired with the
      stimulation. Two assessment sessions will be pretreatment, 1 session immediately
      post-treatment, and 1 session at 3 months follow-up.
Our long-term goal is to develop safe and effective treatments for the communication problems
      of Aphasia due to stroke that restore patients to higher levels of functioning, decrease
      disability, and promote higher quality of life. While language therapy for aphasia is
      effective, improvements are typically slow, and gains may be small. Noninvasive brain
      stimulation has been suggested as a method to enhance outcomes from language therapy. This
      study will examine whether outcomes for language therapy with brain stimulation are different
      from outcomes for language therapy without brain stimulation in people with aphasia. Our
      central hypotheses are (1) targeted right hemisphere HDtDCS (RH-HD-tDCS) administered in
      combination with language treatment will result in greater changes in naming accuracy than
      language treatment with the sham RH-HD-tDCS (2) RH-HD-tDCS plus language treatment will
      result in greater increases in communication within the affected hemisphere compared to
      language treatment plus sham RH-HD-tDCS (3) RH-HD-tDCS plus language treatment will result in
      greater increases in perilesional areas working together immediately post-treatment compared
      to language treatment plus sham RH-HD-tDCS
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Picture Naming of trained items
time frame: 3 months
description: Change in naming of pictures of trained items; 60 pictured items; higher score indicates improvement
measure: Naming Response Time of trained items Scales - IV (WAIS-IV; Wechsler, Coalson, & Railford, 2008)
time frame: 3 months
description: Change in response time of naming of pictures of trained items; 0-20 seconds, decreased response time indicates improvement Scales - IV (WAIS-IV; Wechsler, Coalson, & Railford, 2008)
measure: Naming Efficiency of trained items
time frame: 3 months
description: Change in efficiency of naming of pictures of trained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency
measure: Discourse informativeness - Main Concept Production
time frame: 3 months
description: Change in discourse informativeness as measured by main concept scores; increased values indicate improvement
measure: Efficiency of discourse informativeness - Main Concept Production
time frame: 3 months
description: Change in efficiency of discourse informativeness; accurate and complete main concepts produced over the time of discourse elicitation (ACs/min); larger numbers indicate greater efficiency
measure: Picture Naming of untrained items - Boston Naming Test
time frame: 3 months
description: Change in naming of pictures of untrained items; 60 pictured items; higher score indicates improvement
measure: Naming Response Time of untrained items - Boston Naming Test
time frame: 3 months
description: Change in response time of naming of pictures of untrained items; 0-20 seconds, decreased response time indicates improvement
measure: Naming Efficiency of untrained items - Boston Naming Test
time frame: 3 months
description: Change in efficiency of naming of pictures of untrained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency
arm group label: Experimental: Active cathodal tDCS + Speech-language training
arm group type: Active Comparator
description: In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of active tDCS (x 30 minutes of stimulation) combined with 1 hour simultaneous speech-language training on consecutive weekdays.
arm group label: Comparator: Placebo cathodal tDCS + Speech-language training
arm group type: Sham Comparator
description: In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of sham tDCS (x 30 minutes sham) combined with 1 hour simultaneous speech-language training on consecutive weekdays..
intervention type: Device
intervention name: Active Comparator: Experimental: Active cathodal tDCS + language training
description: Cathodal tDCS raises neuronal membrane potentials, leading to decreased probability of depolarization from incoming stimuli.
Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment.
arm group label: Experimental: Active cathodal tDCS + Speech-language training
other name: Behavioral: Speech and Language Training
intervention type: Behavioral
intervention name: Sham Comparator: Placebo cathodal tDCS + Speech and language
description: Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment. .
arm group label: Comparator: Placebo cathodal tDCS + Speech-language training
criteria: 
gender: All
minimum age: 25 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jessica Richardson, Ph.D.
phone: 505 277-1765
email: jdrichardson@unm.edu
last name: Honey Hubbard
phone: 505-433-7766
email: hhubbard@unm.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of New Mexico
investigator full name: Jessica Richardson
investigator title: Assistant Professor: SOM Neurosurgery
mesh term: Stroke
mesh term: Aphasia
provided document: 