<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/NCT02225314</url>
  </required_header>
  <id_info>
    <org_study_id>ADWilliams2012-647173</org_study_id>
    <nct_id>NCT02225314</nct_id>
  </id_info>
  <brief_title>Computer-based Cognitive Training for Individuals With Parkinson's Disease</brief_title>
  <official_title>Computer-based Cognitive Training for Individuals With Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Virginia Commonwealth University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Computer-Based Cognitive Training for Individuals with Parkinson's Disease&quot; is a 3-arm&#xD;
      randomized controlled trial (RCT) comparing Brain Fitness, InSight, and an active control&#xD;
      (AC) training program to evaluate the feasibility of empirically supported computer-based&#xD;
      cognitive training programs (CCTPs) for patients diagnosed with Parkinson's disease (PD) with&#xD;
      Mild Cognitive Impairment (MCI). This pilot study aims to address the need for increased&#xD;
      interventions to target non-motor symptoms associated with PD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients meeting criteria for MCI will be initially randomized to one of the 3 conditions.&#xD;
      Participants will complete cognitive training exercises on their home or clinic-provided&#xD;
      computers for 60 minutes per day, 5 days per week. Compliance and performance will be&#xD;
      monitored on a weekly basis and at completion of the study. Outcome measures will be&#xD;
      collected one week before initiation of the intervention and within one week completion of&#xD;
      the intervention. Neuropsychological functioning, including tests of processing speed,&#xD;
      attention, and executive functioning, will serve as primary outcome measures. Patient&#xD;
      reported outcomes, including measures of overall QOL and disease-specific QOL, and&#xD;
      support-person reported outcomes (if applicable), including measures of overall QOL and&#xD;
      caregiver burden, will be secondary outcome measures. This pilot study promises to evaluate&#xD;
      computer-based cognitive training in a novel population and expand access to cognitive&#xD;
      rehabilitation services, and is designed to improve cognitive functioning and QOL among a&#xD;
      wide range of individuals with PD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Accuracy on Cognitive Training Quizzes</measure>
    <time_frame>Immediate Post-Intervention</time_frame>
    <description>Percent accuracy of cognitive training quizzes from the cognitive training programs of the RCT will be compared. The quizzes are specific to each cognitive training program. The Brain Fitness quiz is comprised of auditory processing and accuracy tasks. The InSight quiz is comprised of visual processing and working memory tasks. The Active Control quiz is comprised of questions about knowledge, literature, art, and history. Due to the differences between the arms with regards to content, the percent accuracy for each participant will be the outcome measure compared across the three study arms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39)</measure>
    <time_frame>Change from Baseline to 3 Month Follow Up in PDQ-39</time_frame>
    <description>Change in PDQ-39 scores from baseline to 3 month follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 3 Months</measure>
    <time_frame>Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 3 Months</time_frame>
    <description>Change from California Verbal Learning Test-II Long Delay Free Recall Scaled Score from Baseline and 3 Months</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Parkinson's Disease</condition>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Brain Fitness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Brain Fitness is a computer-based cognitive training programs designed to augment auditory processing speed and accuracy over an 8-week period to individuals with PD and MCI at a community Parkinson's and Movement Disorders specialty clinic.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>InSight</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>InSight is a computer-based cognitive training programs designed to augment visual processing and working memory over an 8-week period to individuals with PD and MCI at a community Parkinson's and Movement Disorders specialty clinic.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An active control arm is necessary to model practice effects in an untreated group. Participants in this group will view and complete quizzes on a computerized learning program designed to improve knowledge about literature, art, and history.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brain Fitness</intervention_name>
    <description>Brain Fitness is a computer-based cognitive training programs that consists of six types of exercises that train auditory processing speed and accuracy.</description>
    <arm_group_label>Brain Fitness</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>InSight</intervention_name>
    <description>InSight is a computer-based cognitive training program that consists of five types of exercises that train visual processing and working memory.</description>
    <arm_group_label>InSight</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active Control</intervention_name>
    <description>The Active Control arm is a computerized learning program that consists of five programs (i.e., Wright Brothers, History of Britain, Sister Wendy's American Collection, In Search of Shakespeare, and View the Cosmos) designed to improve knowledge about literature, art, and history.</description>
    <arm_group_label>Active Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants eligible for this study must speak English and have a confirmed medical&#xD;
             diagnosis of Parkinson's disease and meet established criteria for MCI in PD (Litvan&#xD;
             et al., 2012), defined as individuals with performances of approximately -1 to -2&#xD;
             standard deviations below the mean on at least two tests within five cognitive domains&#xD;
             assessed in their clinical neuropsychological evaluations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria include diagnosis of PD dementia based on Movement Disorder Society&#xD;
             Task Force criteria (Emre et al., 2007) and other PD-associated comorbid conditions&#xD;
             (e.g., severe anxiety, depression, excessive daytime sleepiness, or psychosis) that&#xD;
             significantly influence cognitive testing (Litvan et al., 2012).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah K. Lageman, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Commonwealth University Parkinson's and Movement Disorders Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>January 6, 2016</last_update_submitted>
  <last_update_submitted_qc>January 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's Disease</keyword>
  <keyword>Mild Cognitive Impairment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT02225314
org study id: ADWilliams2012-647173
nct id: NCT02225314
lead sponsor: 
has dmc: No
Computer-Based Cognitive Training for Individuals with Parkinson's Disease" is a 3-arm
      randomized controlled trial (RCT) comparing Brain Fitness, InSight, and an active control
      (AC) training program to evaluate the feasibility of empirically supported computer-based
      cognitive training programs (CCTPs) for patients diagnosed with Parkinson's disease (PD) with
      Mild Cognitive Impairment (MCI). This pilot study aims to address the need for increased
      interventions to target non-motor symptoms associated with PD.
Patients meeting criteria for MCI will be initially randomized to one of the 3 conditions.
      Participants will complete cognitive training exercises on their home or clinic-provided
      computers for 60 minutes per day, 5 days per week. Compliance and performance will be
      monitored on a weekly basis and at completion of the study. Outcome measures will be
      collected one week before initiation of the intervention and within one week completion of
      the intervention. Neuropsychological functioning, including tests of processing speed,
      attention, and executive functioning, will serve as primary outcome measures. Patient
      reported outcomes, including measures of overall QOL and disease-specific QOL, and
      support-person reported outcomes (if applicable), including measures of overall QOL and
      caregiver burden, will be secondary outcome measures. This pilot study promises to evaluate
      computer-based cognitive training in a novel population and expand access to cognitive
      rehabilitation services, and is designed to improve cognitive functioning and QOL among a
      wide range of individuals with PD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent Accuracy on Cognitive Training Quizzes
time frame: Immediate Post-Intervention
description: Percent accuracy of cognitive training quizzes from the cognitive training programs of the RCT will be compared. The quizzes are specific to each cognitive training program. The Brain Fitness quiz is comprised of auditory processing and accuracy tasks. The InSight quiz is comprised of visual processing and working memory tasks. The Active Control quiz is comprised of questions about knowledge, literature, art, and history. Due to the differences between the arms with regards to content, the percent accuracy for each participant will be the outcome measure compared across the three study arms.
measure: Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39)
time frame: Change from Baseline to 3 Month Follow Up in PDQ-39
description: Change in PDQ-39 scores from baseline to 3 month follow up.
measure: California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 3 Months
time frame: Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 3 Months
description: Change from California Verbal Learning Test-II Long Delay Free Recall Scaled Score from Baseline and 3 Months
arm group label: Brain Fitness
arm group type: Experimental
description: Brain Fitness is a computer-based cognitive training programs designed to augment auditory processing speed and accuracy over an 8-week period to individuals with PD and MCI at a community Parkinson's and Movement Disorders specialty clinic.
arm group label: InSight
arm group type: Experimental
description: InSight is a computer-based cognitive training programs designed to augment visual processing and working memory over an 8-week period to individuals with PD and MCI at a community Parkinson's and Movement Disorders specialty clinic.
arm group label: Active Control
arm group type: Active Comparator
description: An active control arm is necessary to model practice effects in an untreated group. Participants in this group will view and complete quizzes on a computerized learning program designed to improve knowledge about literature, art, and history.
intervention type: Behavioral
intervention name: Brain Fitness
description: Brain Fitness is a computer-based cognitive training programs that consists of six types of exercises that train auditory processing speed and accuracy.
arm group label: Brain Fitness
intervention type: Behavioral
intervention name: InSight
description: InSight is a computer-based cognitive training program that consists of five types of exercises that train visual processing and working memory.
arm group label: InSight
intervention type: Behavioral
intervention name: Active Control
description: The Active Control arm is a computerized learning program that consists of five programs (i.e., Wright Brothers, History of Britain, Sister Wendy's American Collection, In Search of Shakespeare, and View the Cosmos) designed to improve knowledge about literature, art, and history.
arm group label: Active Control
criteria: 
gender: All
minimum age: 21 Years
maximum age: 90 Years
healthy volunteers: No
last name: Sarah K. Lageman, Ph.D.
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Cognitive Dysfunction