<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/NCT03230656</url>
  </required_header>
  <id_info>
    <org_study_id>1003140</org_study_id>
    <secondary_id>1R15DC015338-01A1</secondary_id>
    <nct_id>NCT03230656</nct_id>
  </id_info>
  <brief_title>Cognitive-Communication Screening and Early Therapy for Adults With Mild TBI</brief_title>
  <official_title>Cognitive-Communication Screening and Early Therapy for Adults With Concussion/Mild Traumatic Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northern Arizona University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Deafness and Other Communication Disorders (NIDCD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Northern Arizona University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Approximately 15-20% of patients diagnosed with a concussion/mild traumatic brain injury&#xD;
      (mTBI) have persistent symptoms that continue up to six months or longer. Typical problems&#xD;
      identified by these patients include difficulty with memory, multi-tasking, the ability to&#xD;
      complete tasks quickly, and higher executive functions (e.g., inhibition, initiation,&#xD;
      insight, motivation) (Belanger &amp; Vanderploeg, 2005; Mott, McConnon, &amp; Rieger, 2012,&#xD;
      Rabinowitz &amp; Levin, 2014). If these symptoms persist they can not only affect thinking, but&#xD;
      also communication abilities (e.g., verbal and nonverbal interactions, reading, and writing)&#xD;
      (ASHA, 2007). Therefore, it is hypothesized that screening measures that evaluate both&#xD;
      thinking and communication can better identify individuals at-risk for persistent symptoms at&#xD;
      two week and four weeks post-injury. Also, if cognitive-communication therapy was&#xD;
      administered earlier post-injury, then outcomes related to return to daily activities, work,&#xD;
      and/or the academic setting could possibly change. This study intends to investigate the use&#xD;
      of cognitive and communication screening measures for the identification of persistent&#xD;
      symptoms and the provision of early cognitive-communication therapy if problems persist.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 15-20% of patients with concussion/mild traumatic brain injury (mTBI) have&#xD;
      persistent cognitive symptoms up to six months or longer. Problems with working memory,&#xD;
      divided attention, processing speed, and executive function are common (Belanger &amp;&#xD;
      Vanderploeg, 2005; Mott, McConnon, &amp; Rieger, 2012, Rabinowitz &amp; Levin, 2014). Patients often&#xD;
      report how these problems negatively impact daily communication. Although neurocognitive&#xD;
      tests are frequently used to identify patients at-risk for persistent symptoms, perhaps tests&#xD;
      that not only assess cognition, but also communication would be better at identifying more&#xD;
      functional deficits. Patients at-risk for persistent symptoms could then begin therapy&#xD;
      earlier to address problems affecting work, school, or everyday activities. Speech-language&#xD;
      pathologists are uniquely qualified to evaluate and treat patients with concussion/mTBI and&#xD;
      cognitive-communication disorders (ASHA, 2005; Cicerone, et al.; Cornis-Pop et al., 2012).&#xD;
      Cognitive-communication is the relationship between cognition and its influence on verbal and&#xD;
      nonverbal communication, reading, and writing (ASHA, 2007). At this time, practice guidelines&#xD;
      are emerging for cognitive-communication intervention related to concussion/mTBI (Cornis-Pop&#xD;
      et al., 2012), yet there is still much research to be done. Typically, in recovery following&#xD;
      a concussion/mTBI, patients are referred for cognitive-communication intervention if they are&#xD;
      failing or struggling at work, school, or in daily activities. Some patients will not be seen&#xD;
      for up to six months based on the assumption by healthcare professionals that most persistent&#xD;
      cognitive and communication symptoms will resolve on their own. The wait period before&#xD;
      referral for additional services is currently being investigated in the literature.&#xD;
      Additionally, therapy for cognitive-communication will only be provided if patients report&#xD;
      difficulties to their physicians and are referred for services. If services are not sought&#xD;
      out, problems in cognitive-communication will go unrecognized as being a result of the&#xD;
      concussion/mTBI.&#xD;
&#xD;
      The specific aims of this study are: 1) Determine if screening measures that evaluate&#xD;
      symptoms of concussion/mTBI frequently used by speech-language pathologists administered two&#xD;
      and four weeks post-injury will be able to predict individuals at-risk for persistent&#xD;
      cognitive and communication symptoms, and 2) Will an early treatment group with persistent&#xD;
      cognitive-communication deficits one month after injury differ in pre- and post-therapy&#xD;
      functional outcome measure scores as compared to a delayed therapy group beginning services&#xD;
      at two months post-injury?&#xD;
&#xD;
      Significance: Results of this study will increase the understanding in the use of cognitive&#xD;
      and communication screening measures frequently administered by speech-language pathologists&#xD;
      to identify patients at-risk for persistent symptoms related to concussion/mTBI and provide&#xD;
      information about the outcomes of cognitive-communication intervention delivered early in&#xD;
      recovery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">May 31, 2021</completion_date>
  <primary_completion_date type="Actual">May 31, 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>Factorial Assignment</intervention_model>
    <intervention_model_description>Each participant diagnosed with concussion/mild traumatic brain injury will be screened for cognitive and communication abilities at two weeks post-injury and then four weeks post-injury. Standardized scores of the screening measures will identify subjects that are below one standard deviation below the mean. Subjects that continue to exhibit deficits after one month will be randomly placed into an early cognitive-communication therapy group (one month post-injury) or waitlist control group who receive therapy two month post-injury.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SCAN-A Competing Sentences Subtest</measure>
    <time_frame>20 minutes</time_frame>
    <description>Assesses working memory, divided attention, and verbal language</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FAVRES Sequencing subtest</measure>
    <time_frame>20 minutes</time_frame>
    <description>Evaluates executive function, verbal language, reading, and writing,</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WJ-III Tests of Cognitive Abilities Matching subtest</measure>
    <time_frame>3 minutes</time_frame>
    <description>Evaluates speed of processing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RBMT-3 Story Immediate and Delayed Recall</measure>
    <time_frame>15</time_frame>
    <description>Assesses working memory and verbal language</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional outcome measure</measure>
    <time_frame>40 minutes</time_frame>
    <description>Same outcome measure will be used to determine functional abilities pre- and post-therapy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Concussion</condition>
  <condition>Mild Traumatic Brain Injury</condition>
  <condition>Cognitive Communication Disorder</condition>
  <arm_group>
    <arm_group_label>Early therapy 1 month post-injury</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Early cognitive-communication therapy 1 month post-injury:&#xD;
working memory strategies&#xD;
executive function program&#xD;
divided attention program&#xD;
environmental changes&#xD;
identification of problematic cognitive-communication situations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist therapy 2 months post-injury</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Waitlist early cognitive-communication therapy 2 months post injury:&#xD;
- Same cognitive-communication therapy is administered</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early cognitive-communication therapy</intervention_name>
    <arm_group_label>Early therapy 1 month post-injury</arm_group_label>
    <arm_group_label>Waitlist therapy 2 months post-injury</arm_group_label>
    <other_name>Early therapy 1 month post-injury</other_name>
    <other_name>Waitlist therapy 2 months post-injury</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed with concussion/mTBI by ER physician&#xD;
&#xD;
          -  speak English as the primary language&#xD;
&#xD;
          -  have functional hearing and vision to take the screening measures&#xD;
&#xD;
          -  have no prior history of a TBI requiring hospitalization and/or rehabilitation&#xD;
&#xD;
          -  have no history of other neurological or psychological diagnoses that would prevent&#xD;
             the completion of the screening measures&#xD;
&#xD;
          -  mild to moderate hearing loss with aided amplification&#xD;
&#xD;
          -  reading glasses to correct their vision&#xD;
&#xD;
          -  bilingual subjects whose primary language is English will be included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  do not live in Flagstaff, AZ or the surrounding area making them unavailable for&#xD;
             follow-up screening or therapy&#xD;
&#xD;
          -  English is not spoken as the primary language&#xD;
&#xD;
          -  have severe hearing loss or vision problems which cannot be corrected with hearing&#xD;
             aids or glasses&#xD;
&#xD;
          -  prior history of a traumatic brain injury requiring hospitalization and/or&#xD;
             rehabilitation&#xD;
&#xD;
          -  history of other neurological or psychological diagnoses preventing the completion of&#xD;
             the screening sessions&#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>Emi Isaki, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northern Arizona University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northern Arizona University</name>
      <address>
        <city>Flagstaff</city>
        <state>Arizona</state>
        <zip>86011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.asha.org/policy</url>
    <description>Roles of speech-language pathologists in the identification, diagnosis, and treatment of individuals with cognitive-communication disorders [Position Statement]</description>
  </link>
  <link>
    <url>http://www.asha.org/policy</url>
    <description>Scope of practice in speech-language pathology [Scope of Practice]</description>
  </link>
  <reference>
    <citation>Belanger HG, Vanderploeg RD. The neuropsychological impact of sports-related concussion: a meta-analysis. J Int Neuropsychol Soc. 2005 Jul;11(4):345-57. doi: 10.1017/s1355617705050411.</citation>
    <PMID>16209414</PMID>
  </reference>
  <reference>
    <citation>Mott TF, McConnon ML, Rieger BP. Subacute to chronic mild traumatic brain injury. Am Fam Physician. 2012 Dec 1;86(11):1045-51.</citation>
    <PMID>23198672</PMID>
  </reference>
  <reference>
    <citation>Rabinowitz AR, Levin HS. Cognitive sequelae of traumatic brain injury. Psychiatr Clin North Am. 2014 Mar;37(1):1-11. doi: 10.1016/j.psc.2013.11.004. Epub 2014 Jan 14.</citation>
    <PMID>24529420</PMID>
  </reference>
  <reference>
    <citation>Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.</citation>
    <PMID>21440699</PMID>
  </reference>
  <reference>
    <citation>Cornis-Pop M, Mashima PA, Roth CR, MacLennan DL, Picon LM, Hammond CS, Goo-Yoshino S, Isaki E, Singson M, Frank EM. Guest editorial: Cognitive-communication rehabilitation for combat-related mild traumatic brain injury. J Rehabil Res Dev. 2012;49(7):xi-xxxii. doi: 10.1682/jrrd.2012.03.0048. No abstract available.</citation>
    <PMID>23341288</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northern Arizona University</investigator_affiliation>
    <investigator_full_name>Emi Isaki</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Brain Concussion</mesh_term>
    <mesh_term>Communication Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual participant data available to researchers outside of the current study. Results related to the study will be disseminated in future presentations and publications.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 13, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03230656/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <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>September 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03230656/ICF_001.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/NCT03230656
org study id: 1003140
secondary id: 1R15DC015338-01A1
nct id: NCT03230656
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Approximately 15-20% of patients diagnosed with a concussion/mild traumatic brain injury
      (mTBI) have persistent symptoms that continue up to six months or longer. Typical problems
      identified by these patients include difficulty with memory, multi-tasking, the ability to
      complete tasks quickly, and higher executive functions (e.g., inhibition, initiation,
      insight, motivation) (Belanger & Vanderploeg, 2005; Mott, McConnon, & Rieger, 2012,
      Rabinowitz & Levin, 2014). If these symptoms persist they can not only affect thinking, but
      also communication abilities (e.g., verbal and nonverbal interactions, reading, and writing)
      (ASHA, 2007). Therefore, it is hypothesized that screening measures that evaluate both
      thinking and communication can better identify individuals at-risk for persistent symptoms at
      two week and four weeks post-injury. Also, if cognitive-communication therapy was
      administered earlier post-injury, then outcomes related to return to daily activities, work,
      and/or the academic setting could possibly change. This study intends to investigate the use
      of cognitive and communication screening measures for the identification of persistent
      symptoms and the provision of early cognitive-communication therapy if problems persist.
Approximately 15-20% of patients with concussion/mild traumatic brain injury (mTBI) have
      persistent cognitive symptoms up to six months or longer. Problems with working memory,
      divided attention, processing speed, and executive function are common (Belanger &
      Vanderploeg, 2005; Mott, McConnon, & Rieger, 2012, Rabinowitz & Levin, 2014). Patients often
      report how these problems negatively impact daily communication. Although neurocognitive
      tests are frequently used to identify patients at-risk for persistent symptoms, perhaps tests
      that not only assess cognition, but also communication would be better at identifying more
      functional deficits. Patients at-risk for persistent symptoms could then begin therapy
      earlier to address problems affecting work, school, or everyday activities. Speech-language
      pathologists are uniquely qualified to evaluate and treat patients with concussion/mTBI and
      cognitive-communication disorders (ASHA, 2005; Cicerone, et al.; Cornis-Pop et al., 2012).
      Cognitive-communication is the relationship between cognition and its influence on verbal and
      nonverbal communication, reading, and writing (ASHA, 2007). At this time, practice guidelines
      are emerging for cognitive-communication intervention related to concussion/mTBI (Cornis-Pop
      et al., 2012), yet there is still much research to be done. Typically, in recovery following
      a concussion/mTBI, patients are referred for cognitive-communication intervention if they are
      failing or struggling at work, school, or in daily activities. Some patients will not be seen
      for up to six months based on the assumption by healthcare professionals that most persistent
      cognitive and communication symptoms will resolve on their own. The wait period before
      referral for additional services is currently being investigated in the literature.
      Additionally, therapy for cognitive-communication will only be provided if patients report
      difficulties to their physicians and are referred for services. If services are not sought
      out, problems in cognitive-communication will go unrecognized as being a result of the
      concussion/mTBI.

      The specific aims of this study are: 1) Determine if screening measures that evaluate
      symptoms of concussion/mTBI frequently used by speech-language pathologists administered two
      and four weeks post-injury will be able to predict individuals at-risk for persistent
      cognitive and communication symptoms, and 2) Will an early treatment group with persistent
      cognitive-communication deficits one month after injury differ in pre- and post-therapy
      functional outcome measure scores as compared to a delayed therapy group beginning services
      at two months post-injury?

      Significance: Results of this study will increase the understanding in the use of cognitive
      and communication screening measures frequently administered by speech-language pathologists
      to identify patients at-risk for persistent symptoms related to concussion/mTBI and provide
      information about the outcomes of cognitive-communication intervention delivered early in
      recovery.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Each participant diagnosed with concussion/mild traumatic brain injury will be screened for cognitive and communication abilities at two weeks post-injury and then four weeks post-injury. Standardized scores of the screening measures will identify subjects that are below one standard deviation below the mean. Subjects that continue to exhibit deficits after one month will be randomly placed into an early cognitive-communication therapy group (one month post-injury) or waitlist control group who receive therapy two month post-injury.
primary purpose: Screening
masking: None (Open Label)
measure: SCAN-A Competing Sentences Subtest
time frame: 20 minutes
description: Assesses working memory, divided attention, and verbal language
measure: FAVRES Sequencing subtest
time frame: 20 minutes
description: Evaluates executive function, verbal language, reading, and writing,
measure: WJ-III Tests of Cognitive Abilities Matching subtest
time frame: 3 minutes
description: Evaluates speed of processing
measure: RBMT-3 Story Immediate and Delayed Recall
time frame: 15
description: Assesses working memory and verbal language
measure: Functional outcome measure
time frame: 40 minutes
description: Same outcome measure will be used to determine functional abilities pre- and post-therapy
arm group label: Early therapy 1 month post-injury
arm group type: Experimental
description: Early cognitive-communication therapy 1 month post-injury:
working memory strategies
executive function program
divided attention program
environmental changes
identification of problematic cognitive-communication situations
arm group label: Waitlist therapy 2 months post-injury
arm group type: Active Comparator
description: Waitlist early cognitive-communication therapy 2 months post injury:
- Same cognitive-communication therapy is administered
intervention type: Other
intervention name: Early cognitive-communication therapy
arm group label: Early therapy 1 month post-injury
arm group label: Waitlist therapy 2 months post-injury
other name: Early therapy 1 month post-injury
other name: Waitlist therapy 2 months post-injury
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Emi Isaki, Ph.D.
role: Principal Investigator
affiliation: Northern Arizona University
facility: 
country: United States
url: http://www.asha.org/policy
description: Roles of speech-language pathologists in the identification, diagnosis, and treatment of individuals with cognitive-communication disorders [Position Statement]
url: http://www.asha.org/policy
description: Scope of practice in speech-language pathology [Scope of Practice]
citation: Belanger HG, Vanderploeg RD. The neuropsychological impact of sports-related concussion: a meta-analysis. J Int Neuropsychol Soc. 2005 Jul;11(4):345-57. doi: 10.1017/s1355617705050411.
PMID: 16209414
citation: Mott TF, McConnon ML, Rieger BP. Subacute to chronic mild traumatic brain injury. Am Fam Physician. 2012 Dec 1;86(11):1045-51.
PMID: 23198672
citation: Rabinowitz AR, Levin HS. Cognitive sequelae of traumatic brain injury. Psychiatr Clin North Am. 2014 Mar;37(1):1-11. doi: 10.1016/j.psc.2013.11.004. Epub 2014 Jan 14.
PMID: 24529420
citation: Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.
PMID: 21440699
citation: Cornis-Pop M, Mashima PA, Roth CR, MacLennan DL, Picon LM, Hammond CS, Goo-Yoshino S, Isaki E, Singson M, Frank EM. Guest editorial: Cognitive-communication rehabilitation for combat-related mild traumatic brain injury. J Rehabil Res Dev. 2012;49(7):xi-xxxii. doi: 10.1682/jrrd.2012.03.0048. No abstract available.
PMID: 23341288
responsible party type: Principal Investigator
investigator affiliation: Northern Arizona University
investigator full name: Emi Isaki
investigator title: Associate Professor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion
mesh term: Communication Disorders
sharing ipd: No
ipd description: There is no plan to make individual participant data available to researchers outside of the current study. Results related to the study will be disseminated in future presentations and publications.
provided document: 
provided document: 