<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/NCT03786276</url>
  </required_header>
  <id_info>
    <org_study_id>VR-WMR</org_study_id>
    <nct_id>NCT03786276</nct_id>
  </id_info>
  <brief_title>Virtual Reality- Working Memory Retraining</brief_title>
  <acronym>VR-WMR</acronym>
  <official_title>Effects of Active Virtual Reality Working Memory Retraining on Heavy Drinking Veterans With Mild Traumatic Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>San Francisco VA Health Care System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</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>
      This study will establish the acceptability and feasibility of enrolling and retaining heavy&#xD;
      drinking Veterans with mild traumatic brain injury (mTBI) in an 8-week, randomized cross-over&#xD;
      design trial of active VR working memory retraining (WMR). This study will also seek to&#xD;
      establish the efficacy of active VR-WMR to increase performance in executive function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will employ a physically active VR working memory retraining (VR-WMR)&#xD;
      regimen utilizing components of Blue Goji VR Active Gaming. The synthesis of physical&#xD;
      activity and an enriched VR environment is expected to yield superior working memory training&#xD;
      stemming from greater neurological activation. This enhanced working memory training task&#xD;
      will result in greater motivation to engage and complete a training regimen, thus fostering&#xD;
      greater improvements in executive function than traditional working memory training tasks;&#xD;
      ultimately resulting in increased self-control over alcohol use and other high-risk&#xD;
      behaviors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</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>
    <intervention_model_description>We will use an 8-week, randomized cross--over design trial of active VR-WMR.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>System Usability Scale</measure>
    <time_frame>18 months</time_frame>
    <description>A validated measure of technology usability will be administered at end of study to assess the usability of Active VR-WMR.The System Usability Scale (SUS) is a reliable 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree used to measure product usability. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. An SUS score above a 68 would be considered above average and anything below 68 is below average.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Client Satisfaction Questionnaire</measure>
    <time_frame>18 months</time_frame>
    <description>A validated measure of client satisfaction with an intervention will be administered at the end of study to evaluate satisfaction with Active VR-WMR. Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction) with different descriptors for each response point. Total scores range from 8 to 32, with higher scores indicating greater satisfaction. A standard mean rating of ≥ 24 will be considered acceptable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Working Memory</measure>
    <time_frame>18 months</time_frame>
    <description>Change in working memory in each arm will be evaluated. Working Memory consists of well validated WAIS-IV Arithmetic and Digit Span Subscales. Working memory will be the average of the scaled scores (ss) of each subscale, with a mean (M) = 10 and a standard deviation (SD) = 3. The subtest ss range from 1 to 19.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <condition>Mild Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Exercise-Only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise-Only condition, 12 exercise sessions on a stationary recumbent bicycle over 4 weeks. After 4 weeks, the participants will have a 1-week washout followed by Active VR-WMR arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VR-WMR-Only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Virtual Reality Working Memory Retraining-Only condition, 12 working memory retraining sessions over 4 weeks. After 4 weeks, the participants will have a 1-week washout followed by Active VR-WMR arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active VR-WMR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After 4 weeks in one of the first two arms, the participants will have a 1-week washout followed by the Active VR-WMR arm. Participants will complete 12 Active VR-WMR sessions on a stationary recumbent bicycle over 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>VR-WMR-Only</intervention_name>
    <description>Participants will spend up to 30 minutes in a VR-WMR environment during each training session.</description>
    <arm_group_label>VR-WMR-Only</arm_group_label>
    <other_name>Virtual Reality-Working Memory Retraining</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise-only</intervention_name>
    <description>Participants will ride a stationary recumbent bicycle for up to 30 minutes during each training session.</description>
    <arm_group_label>Exercise-Only</arm_group_label>
    <other_name>Recumbent bicycle</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active VR-WMR</intervention_name>
    <description>Participants will spend up to 30 minutes in a VR-WMR environment while riding a stationary, recumbent bicycle during each training session.</description>
    <arm_group_label>Active VR-WMR</arm_group_label>
    <other_name>Active Virtual Reality-Working Memory Retraining</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  must report &quot;heavy&quot; drinking by NIH/NIAAA criteria (&gt;7 drinks/week for women; &gt;14&#xD;
             drinks/week for men) for at least one week in the last 90 days&#xD;
&#xD;
          -  must meet moderate to severe criteria for current (past year) alcohol use disorder&#xD;
             (AUD) by DSM-5&#xD;
&#xD;
          -  must express a desire to reduce, stop, or maintain cessation of alcohol use&#xD;
&#xD;
          -  must report a history of TBI as defined by American Congress of Rehabilitation&#xD;
             Medicine (ACRM), in the chronic, stable phase of recovery (&gt;6 months from injury)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable medical or psychiatric disorders judged to be unstable in the clinical&#xD;
             judgment of the PI&#xD;
&#xD;
          -  Current or past history of intrinsic cerebral tumors, HIV infection, cerebrovascular&#xD;
             accident, aneurysm, arteriovenous malformations, myocardial infarction,&#xD;
             cerebrovascular or peripheral vascular disease, type-1 diabetes, any cardiac, hepatic&#xD;
             or renal diseases/disorders, surgical implantation of neurostimulators or cardiac&#xD;
             pacemakers, medically diagnosed chronic obstructive pulmonary disease, demyelinating&#xD;
             and neurodegenerative diseases, history of seizure disorder, and/or any physical&#xD;
             disability making it impossible to use exercise equipment&#xD;
&#xD;
          -  No female participant will be pregnant or attempting to conceive&#xD;
&#xD;
          -  Concurrent participation in an AUD, cognitive training, or exercise study&#xD;
&#xD;
          -  Must not require acute medical detoxification from alcohol (CIWA-AD &gt; 11) within the&#xD;
             past week prior to study entry&#xD;
&#xD;
          -  Subjects who, in the opinion of the investigator, are otherwise unsuitable for a study&#xD;
             of this type will be excluded&#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>David L Pennington, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Medical Center San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>April 30, 2020</last_update_submitted>
  <last_update_submitted_qc>April 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alcohol Use Disorder</keyword>
  <keyword>Traumatic Brain Injury</keyword>
  <keyword>Working Memory Training</keyword>
  <keyword>Virtual Reality</keyword>
  <keyword>Physical Exercise</keyword>
  <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>Alcoholism</mesh_term>
    <mesh_term>Alcohol Drinking</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/NCT03786276
org study id: VR-WMR
nct id: NCT03786276
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will establish the acceptability and feasibility of enrolling and retaining heavy
      drinking Veterans with mild traumatic brain injury (mTBI) in an 8-week, randomized cross-over
      design trial of active VR working memory retraining (WMR). This study will also seek to
      establish the efficacy of active VR-WMR to increase performance in executive function.
The investigators will employ a physically active VR working memory retraining (VR-WMR)
      regimen utilizing components of Blue Goji VR Active Gaming. The synthesis of physical
      activity and an enriched VR environment is expected to yield superior working memory training
      stemming from greater neurological activation. This enhanced working memory training task
      will result in greater motivation to engage and complete a training regimen, thus fostering
      greater improvements in executive function than traditional working memory training tasks;
      ultimately resulting in increased self-control over alcohol use and other high-risk
      behaviors.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: We will use an 8-week, randomized cross--over design trial of active VR-WMR.
primary purpose: Other
masking: None (Open Label)
measure: System Usability Scale
time frame: 18 months
description: A validated measure of technology usability will be administered at end of study to assess the usability of Active VR-WMR.The System Usability Scale (SUS) is a reliable 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree used to measure product usability. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. An SUS score above a 68 would be considered above average and anything below 68 is below average.
measure: The Client Satisfaction Questionnaire
time frame: 18 months
description: A validated measure of client satisfaction with an intervention will be administered at the end of study to evaluate satisfaction with Active VR-WMR. Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction) with different descriptors for each response point. Total scores range from 8 to 32, with higher scores indicating greater satisfaction. A standard mean rating of ≥ 24 will be considered acceptable.
measure: Working Memory
time frame: 18 months
description: Change in working memory in each arm will be evaluated. Working Memory consists of well validated WAIS-IV Arithmetic and Digit Span Subscales. Working memory will be the average of the scaled scores (ss) of each subscale, with a mean (M) = 10 and a standard deviation (SD) = 3. The subtest ss range from 1 to 19.
arm group label: Exercise-Only
arm group type: Experimental
description: Exercise-Only condition, 12 exercise sessions on a stationary recumbent bicycle over 4 weeks. After 4 weeks, the participants will have a 1-week washout followed by Active VR-WMR arm.
arm group label: VR-WMR-Only
arm group type: Experimental
description: Virtual Reality Working Memory Retraining-Only condition, 12 working memory retraining sessions over 4 weeks. After 4 weeks, the participants will have a 1-week washout followed by Active VR-WMR arm.
arm group label: Active VR-WMR
arm group type: Experimental
description: After 4 weeks in one of the first two arms, the participants will have a 1-week washout followed by the Active VR-WMR arm. Participants will complete 12 Active VR-WMR sessions on a stationary recumbent bicycle over 4 weeks.
intervention type: Behavioral
intervention name: VR-WMR-Only
description: Participants will spend up to 30 minutes in a VR-WMR environment during each training session.
arm group label: VR-WMR-Only
other name: Virtual Reality-Working Memory Retraining
intervention type: Behavioral
intervention name: Exercise-only
description: Participants will ride a stationary recumbent bicycle for up to 30 minutes during each training session.
arm group label: Exercise-Only
other name: Recumbent bicycle
intervention type: Behavioral
intervention name: Active VR-WMR
description: Participants will spend up to 30 minutes in a VR-WMR environment while riding a stationary, recumbent bicycle during each training session.
arm group label: Active VR-WMR
other name: Active Virtual Reality-Working Memory Retraining
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: David L Pennington, Ph.D.
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion
mesh term: Alcoholism
mesh term: Alcohol Drinking