xml: <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/NCT05980897</url>
    </required_header>
    <id_info>
      <org_study_id>NCR224453</org_study_id>
      <nct_id>NCT05980897</nct_id>
    </id_info>
    <brief_title>Inner Speech and Naming Treatment for Individuals With Aphasia</brief_title>
    <official_title>Inner Speech and Naming Treatment for Individuals With Aphasia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>George Washington University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>George Washington University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Aphasia is a language disorder, commonly resulting from stroke or other brain injury, that&#xD;
        impacts a person's ability to communicate. This project is looking to improve upon current&#xD;
        treatment methods for spoken naming in people with aphasia. People with aphasia frequently&#xD;
        report being able to successfully say a word in their head, regardless of their ability to&#xD;
        say the word out loud. For example, when presented with a picture of a house, they may report&#xD;
        being able to think or hear &quot;house&quot; in their head, even if they can't name it out loud. This&#xD;
        &quot;little voice&quot; inside one's head is known as inner speech (IS). Previous research suggests&#xD;
        that some people with aphasia can re-learn to say words with successful IS (i.e., words they&#xD;
        can already say in their heads) easier and faster than words with unsuccessful IS. This study&#xD;
        will extend these findings by implementing a comparative treatment study in a larger group of&#xD;
        participants with aphasia. The results will help to establish recommendations for&#xD;
        speech-language pathologists in choosing treatment stimuli for anomia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Aphasia, a language disorder commonly acquired through stroke, has chronic negative impacts&#xD;
        on communication abilities and quality of life. The specific language deficits associated&#xD;
        with aphasia typically vary from person to person, but a universal element of aphasia is&#xD;
        anomia, or difficulty with naming and word-finding. It is well-known that individuals with&#xD;
        aphasia struggle to convey their ideas through overt speech, but little is known about this&#xD;
        population's ability to access and utilize inner speech (IS). IS can be defined in many ways,&#xD;
        but one simple definition that is well known to most language users is the mental imagery of&#xD;
        having a little voice in one's head. Importantly, individuals with aphasia often endorse a&#xD;
        mismatch between this &quot;little voice&quot; (IS) and what they can actually say out loud. In a prior&#xD;
        interview-based study, over 75% of individuals with aphasia endorsed the specific experience&#xD;
        of being able to say a word in their head despite being unable to say it aloud.&#xD;
  &#xD;
        Previous research examined whether self-reported &quot;successful IS&quot; (sIS) (i.e., I can say the&#xD;
        word in my head and it sounds right) predicted therapy outcomes in two participants. In both&#xD;
        participants, self-reported IS predicted whether or not (and how quickly) individual words&#xD;
        were successfully re-learned during a paired-associate treatment for anomia, and the effect&#xD;
        was visible within just a few treatment sessions. This trial provides preliminary evidence&#xD;
        that IS can be leveraged to improve outcomes of naming therapy for individuals with aphasia.&#xD;
        This study aims to extend these prior finding by implementing a behavioral treatment for&#xD;
        anomia using a single-subject experimental design in a larger group of individuals with&#xD;
        aphasia.&#xD;
  &#xD;
        The investigators predict that items reported as sIS will be more effectively learned during&#xD;
        anomia treatment than items that are reported as uIS. Because sIS items are already being&#xD;
        retrieved by the individual, one can think of them as being closer to successful spoken&#xD;
        output than items that are not able to be retrieved (i.e., those reported as uIS).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">July 5, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Alternating treatment single-subject experimental design</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Naming accuracy for sIS vs. uIS items (of 100%)</measure>
      <time_frame>5 weeks</time_frame>
      <description>A direct comparison of treatment response for successful inner speech (sIS) vs. unsuccessful inner speech (uIS) items, measured via accuracy on a spoken naming test.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall naming accuracy (of 100%)</measure>
      <time_frame>5 weeks</time_frame>
      <description>A comparison of pre-treatment (average of three baseline sessions) to post-treatment spoken naming (40 items) across participants</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Aphasia</condition>
    <condition>Anomia</condition>
    <condition>Language Disorders</condition>
    <condition>Communication Disorders</condition>
    <arm_group>
      <arm_group_label>Naming Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will complete three sessions of baseline probe testing (40 treatment items) occurring virtually on three consecutive days prior to treatment onset. Participants will then complete 10 sessions of therapy scheduled five days a week for two weeks, all occurring virtually. The treatment approach for this study will be a hierarchical, cueing-based treatment for naming.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Naming treatment</intervention_name>
      <description>In this alternating treatment single-subject experimental design study, the investigators will alternate between two treatment conditions, i.e., two different types of stimulus items: those that are consistently reported as successful IS prior to treatment (sIS items) and those that are consistently reported as unsuccessful IS prior to treatment (uIS items). The treatment will be computerized to ensure consistency of presentation, timing, and cues across participants.&#xD;
  For each stimulus presentation, the treatment hierarchy will proceed as follows:&#xD;
  Name the picture independently&#xD;
  Name the picture with a written cue&#xD;
  Repeat the name of the picture&#xD;
  Name the picture after a 5 second delay Each participant will be trained on a set of 40 items chosen specifically for them based on initial/baseline testing.</description>
      <arm_group_label>Naming Treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Have aphasia resulting from stroke occurring at least 6 months ago&#xD;
  &#xD;
            -  Are at least 18 years old&#xD;
  &#xD;
            -  Learned English at age 5 years or younger&#xD;
  &#xD;
            -  Normal or corrected-to-normal hearing and vision&#xD;
  &#xD;
            -  Have access to reliable internet at home for remote participation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have a history of other brain conditions that could impact interpretation of results&#xD;
               (such as Parkinson's Disease or dementia)&#xD;
  &#xD;
            -  Have a history of psychiatric disease requiring hospitalization, electroconvulsive&#xD;
               therapy, or ongoing medication use (other than common antidepressants)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mackenzie Fama</last_name>
      <role>Principal Investigator</role>
      <affiliation>The George Washington University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>The George Washington University</name>
        <address>
          <city>Washington</city>
          <state>District of Columbia</state>
          <zip>20052</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Fama ME, Hayward W, Snider SF, Friedman RB, Turkeltaub PE. Subjective experience of inner speech in aphasia: Preliminary behavioral relationships and neural correlates. Brain Lang. 2017 Jan;164:32-42. doi: 10.1016/j.bandl.2016.09.009. Epub 2016 Sep 29.</citation>
      <PMID>27694017</PMID>
    </reference>
    <reference>
      <citation>Fama ME, Snider SF, Henderson MP, Hayward W, Friedman RB, Turkeltaub PE. The Subjective Experience of Inner Speech in Aphasia Is a Meaningful Reflection of Lexical Retrieval. J Speech Lang Hear Res. 2019 Jan 30;62(1):106-122. doi: 10.1044/2018_JSLHR-L-18-0222.</citation>
      <PMID>30950758</PMID>
    </reference>
    <reference>
      <citation>Fama ME, Henderson MP, Snider SF, Hayward W, Friedman RB, Turkeltaub PE. Self-reported inner speech relates to phonological retrieval ability in people with aphasia. Conscious Cogn. 2019 May;71:18-29. doi: 10.1016/j.concog.2019.03.005. Epub 2019 Mar 25.</citation>
      <PMID>30921682</PMID>
    </reference>
    <reference>
      <citation>Fama ME, Turkeltaub PE. Inner Speech in Aphasia: Current Evidence, Clinical Implications, and Future Directions. Am J Speech Lang Pathol. 2020 Feb 21;29(1S):560-573. doi: 10.1044/2019_AJSLP-CAC48-18-0212. Epub 2019 Sep 13.</citation>
      <PMID>31518502</PMID>
    </reference>
    <reference>
      <citation>Hayward W, Snider SF, Luta G, Friedman RB, Turkeltaub PE. Objective support for subjective reports of successful inner speech in two people with aphasia. Cogn Neuropsychol. 2016 Jul-Sep;33(5-6):299-314. doi: 10.1080/02643294.2016.1192998. Epub 2016 Jul 29.</citation>
      <PMID>27469037</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>George Washington University</investigator_affiliation>
      <investigator_full_name>Mackenzie Fama</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Aphasia</keyword>
    <keyword>Anomia</keyword>
    <keyword>Speech-Language Pathology</keyword>
    <keyword>Speech Therapy</keyword>
    <keyword>Inner Speech</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aphasia</mesh_term>
      <mesh_term>Language Disorders</mesh_term>
      <mesh_term>Communication Disorders</mesh_term>
      <mesh_term>Anomia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Investigators will share de-identified data and/or testing materials with interested researchers, educators or clinicians upon request.</ipd_description>
      <ipd_time_frame>Data will be made accessible at the time of initial publication.</ipd_time_frame>
      <ipd_access_criteria>Access to participant data by an external researcher may require a formal data sharing agreement with that researcher's institution.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05980897
  org study id: NCR224453
  nct id: NCT05980897
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Aphasia is a language disorder, commonly resulting from stroke or other brain injury, that
        impacts a person's ability to communicate. This project is looking to improve upon current
        treatment methods for spoken naming in people with aphasia. People with aphasia frequently
        report being able to successfully say a word in their head, regardless of their ability to
        say the word out loud. For example, when presented with a picture of a house, they may report
        being able to think or hear "house" in their head, even if they can't name it out loud. This
        "little voice" inside one's head is known as inner speech (IS). Previous research suggests
        that some people with aphasia can re-learn to say words with successful IS (i.e., words they
        can already say in their heads) easier and faster than words with unsuccessful IS. This study
        will extend these findings by implementing a comparative treatment study in a larger group of
        participants with aphasia. The results will help to establish recommendations for
        speech-language pathologists in choosing treatment stimuli for anomia.
  Aphasia, a language disorder commonly acquired through stroke, has chronic negative impacts
        on communication abilities and quality of life. The specific language deficits associated
        with aphasia typically vary from person to person, but a universal element of aphasia is
        anomia, or difficulty with naming and word-finding. It is well-known that individuals with
        aphasia struggle to convey their ideas through overt speech, but little is known about this
        population's ability to access and utilize inner speech (IS). IS can be defined in many ways,
        but one simple definition that is well known to most language users is the mental imagery of
        having a little voice in one's head. Importantly, individuals with aphasia often endorse a
        mismatch between this "little voice" (IS) and what they can actually say out loud. In a prior
        interview-based study, over 75% of individuals with aphasia endorsed the specific experience
        of being able to say a word in their head despite being unable to say it aloud.
  
        Previous research examined whether self-reported "successful IS" (sIS) (i.e., I can say the
        word in my head and it sounds right) predicted therapy outcomes in two participants. In both
        participants, self-reported IS predicted whether or not (and how quickly) individual words
        were successfully re-learned during a paired-associate treatment for anomia, and the effect
        was visible within just a few treatment sessions. This trial provides preliminary evidence
        that IS can be leveraged to improve outcomes of naming therapy for individuals with aphasia.
        This study aims to extend these prior finding by implementing a behavioral treatment for
        anomia using a single-subject experimental design in a larger group of individuals with
        aphasia.
  
        The investigators predict that items reported as sIS will be more effectively learned during
        anomia treatment than items that are reported as uIS. Because sIS items are already being
        retrieved by the individual, one can think of them as being closer to successful spoken
        output than items that are not able to be retrieved (i.e., those reported as uIS).
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Alternating treatment single-subject experimental design
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Naming accuracy for sIS vs. uIS items (of 100%)
  time frame: 5 weeks
  description: A direct comparison of treatment response for successful inner speech (sIS) vs. unsuccessful inner speech (uIS) items, measured via accuracy on a spoken naming test.
  measure: Overall naming accuracy (of 100%)
  time frame: 5 weeks
  description: A comparison of pre-treatment (average of three baseline sessions) to post-treatment spoken naming (40 items) across participants
  arm group label: Naming Treatment
  arm group type: Experimental
  description: Participants will complete three sessions of baseline probe testing (40 treatment items) occurring virtually on three consecutive days prior to treatment onset. Participants will then complete 10 sessions of therapy scheduled five days a week for two weeks, all occurring virtually. The treatment approach for this study will be a hierarchical, cueing-based treatment for naming.
  intervention type: Behavioral
  intervention name: Naming treatment
  description: In this alternating treatment single-subject experimental design study, the investigators will alternate between two treatment conditions, i.e., two different types of stimulus items: those that are consistently reported as successful IS prior to treatment (sIS items) and those that are consistently reported as unsuccessful IS prior to treatment (uIS items). The treatment will be computerized to ensure consistency of presentation, timing, and cues across participants.
  For each stimulus presentation, the treatment hierarchy will proceed as follows:
  Name the picture independently
  Name the picture with a written cue
  Repeat the name of the picture
  Name the picture after a 5 second delay Each participant will be trained on a set of 40 items chosen specifically for them based on initial/baseline testing.
  arm group label: Naming Treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mackenzie Fama
  role: Principal Investigator
  affiliation: The George Washington University
  facility: 
  country: United States
  citation: Fama ME, Hayward W, Snider SF, Friedman RB, Turkeltaub PE. Subjective experience of inner speech in aphasia: Preliminary behavioral relationships and neural correlates. Brain Lang. 2017 Jan;164:32-42. doi: 10.1016/j.bandl.2016.09.009. Epub 2016 Sep 29.
  PMID: 27694017
  citation: Fama ME, Snider SF, Henderson MP, Hayward W, Friedman RB, Turkeltaub PE. The Subjective Experience of Inner Speech in Aphasia Is a Meaningful Reflection of Lexical Retrieval. J Speech Lang Hear Res. 2019 Jan 30;62(1):106-122. doi: 10.1044/2018_JSLHR-L-18-0222.
  PMID: 30950758
  citation: Fama ME, Henderson MP, Snider SF, Hayward W, Friedman RB, Turkeltaub PE. Self-reported inner speech relates to phonological retrieval ability in people with aphasia. Conscious Cogn. 2019 May;71:18-29. doi: 10.1016/j.concog.2019.03.005. Epub 2019 Mar 25.
  PMID: 30921682
  citation: Fama ME, Turkeltaub PE. Inner Speech in Aphasia: Current Evidence, Clinical Implications, and Future Directions. Am J Speech Lang Pathol. 2020 Feb 21;29(1S):560-573. doi: 10.1044/2019_AJSLP-CAC48-18-0212. Epub 2019 Sep 13.
  PMID: 31518502
  citation: Hayward W, Snider SF, Luta G, Friedman RB, Turkeltaub PE. Objective support for subjective reports of successful inner speech in two people with aphasia. Cogn Neuropsychol. 2016 Jul-Sep;33(5-6):299-314. doi: 10.1080/02643294.2016.1192998. Epub 2016 Jul 29.
  PMID: 27469037
  responsible party type: Principal Investigator
  investigator affiliation: George Washington University
  investigator full name: Mackenzie Fama
  investigator title: Assistant Professor
  mesh term: Aphasia
  mesh term: Language Disorders
  mesh term: Communication Disorders
  mesh term: Anomia
  sharing ipd: Yes
  ipd description: Investigators will share de-identified data and/or testing materials with interested researchers, educators or clinicians upon request.
  ipd time frame: Data will be made accessible at the time of initial publication.
  ipd access criteria: Access to participant data by an external researcher may require a formal data sharing agreement with that researcher's institution.