<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/NCT03836963</url>
  </required_header>
  <id_info>
    <org_study_id>N3015-P</org_study_id>
    <secondary_id>RX003015</secondary_id>
    <nct_id>NCT03836963</nct_id>
  </id_info>
  <brief_title>Cognitive Rehab for Parkinson's</brief_title>
  <official_title>Cognitive Rehabilitation for Veterans With Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the feasibility of an at-home cognitive training program that&#xD;
      incorporates both memory training and online computerized cognitive training (CCT) software.&#xD;
      Data will also be collected to determine if this program improves thinking and memory as well&#xD;
      as everyday function. The hypothesis is that memory and cognitive training combined ,&#xD;
      compared to memory training alone or will lead to greater improvements in cognitive&#xD;
      performance and daily function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to examine feasibility of an at-home cognitive rehabilitation&#xD;
      program that incorporates both prospective implementation intentions strategies (PRIIS) and&#xD;
      an existing web-based executive function (EF) computerized cognitive training (CCT) software&#xD;
      for Veterans with Parkinson's disease (PD) and to collect pilot data to determine the impact&#xD;
      of this program on cognition and everyday function. The central hypothesis is that CCT+PRIIS,&#xD;
      compared to CCT alone and an active control group, will lead to greater improvements in&#xD;
      cognitive performance and daily function. This innovative study uses a set of on-line&#xD;
      training games that target aspects of EF susceptible in PD and trains the transfer of&#xD;
      cognitive benefits to everyday function, using PRIIS, for Veterans with PD and mild cognitive&#xD;
      impairment in executive function. Additionally, training is conducted at home allowing for&#xD;
      convenience and flexibility for participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 27, 2020</start_date>
  <completion_date type="Actual">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">October 1, 2022</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>
    <intervention_model_description>randomized control trial. three arms to the study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in NIH sponsored Executive Abilities: Measures and Instruments for neurobehavioral evaluation and re-search (NIH-EXAMINER) executive composite score</measure>
    <time_frame>week 0 (before intervention begins), 8 weeks, 12 weeks</time_frame>
    <description>The NIH-EXAMINER has an established 3-factor model defined by (1) cognitive control, (2) working memory (3) fluency. A confirmatory factor analysis indicates these 3-factors load on to 1-factor: executive composite score. Seven tests in the NIH-EXAMINER will be used to compute the composite score</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Parkinson's Disease</condition>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>cognitive and memory strategy training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cognitive and memory strategy control training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>active control for cognitive and memory strategy training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>cognitive training</intervention_name>
    <description>Cognitive training consists of a set of computerize games played on an iPad at home. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours.</description>
    <arm_group_label>cognitive and memory strategy control training</arm_group_label>
    <arm_group_label>cognitive and memory strategy training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>active control cognitive training</intervention_name>
    <description>The active control consists of a set of computerized games played on an iPad. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours.</description>
    <arm_group_label>active control for cognitive and memory strategy training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>memory strategy training</intervention_name>
    <description>the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish.</description>
    <arm_group_label>cognitive and memory strategy training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>memory strategy training</intervention_name>
    <description>the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish.</description>
    <arm_group_label>active control for cognitive and memory strategy training</arm_group_label>
    <arm_group_label>cognitive and memory strategy control training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veterans who seek services at Hines VA Hospital&#xD;
&#xD;
          -  Diagnosis of PD as determined by the UK Parkinson's Disease Society Brain Bank&#xD;
             Diagnostic Criteria&#xD;
&#xD;
          -  Meet criteria for having mild cognitive impairment&#xD;
&#xD;
          -  Receiving stable (i.e., no changes in medication and medication dose) medication and&#xD;
             who are expected to remain on stable medication for the duration of the RCT&#xD;
&#xD;
          -  50 years or older&#xD;
&#xD;
          -  Speak and read English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Failure to demonstrate decision making capacity&#xD;
&#xD;
          -  Cholinesterase inhibitor medication&#xD;
&#xD;
          -  History of deep brain stimulation surgery&#xD;
&#xD;
          -  Severe depression&#xD;
&#xD;
          -  Severe anxiety&#xD;
&#xD;
          -  Severe apathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandra L. Kletzel, PhD BA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Edward Hines Jr. VA Hospital, Hines, IL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Edward Hines Jr. VA Hospital, Hines, IL</name>
      <address>
        <city>Hines</city>
        <state>Illinois</state>
        <zip>60141-3030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>February 24, 2023</last_update_submitted>
  <last_update_submitted_qc>February 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's disease</keyword>
  <keyword>cognition</keyword>
  <keyword>cognitive training</keyword>
  <keyword>prospective memory</keyword>
  <keyword>executive function</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Raw and/or normalized data will be made available in the form of Excel files.</ipd_description>
    <ipd_time_frame>Final data sets will be made available as per Hines VA Hospital local policy for long term storage and access until enterprise-level resources become available.</ipd_time_frame>
    <ipd_access_criteria>These data will be available upon request by researchers and scientists in accordance with federal guidelines and Hines local policy.</ipd_access_criteria>
  </patient_data>
  <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>May 10, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03836963/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/NCT03836963
org study id: N3015-P
secondary id: RX003015
nct id: NCT03836963
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study will examine the feasibility of an at-home cognitive training program that
      incorporates both memory training and online computerized cognitive training (CCT) software.
      Data will also be collected to determine if this program improves thinking and memory as well
      as everyday function. The hypothesis is that memory and cognitive training combined ,
      compared to memory training alone or will lead to greater improvements in cognitive
      performance and daily function.
The objective of this study is to examine feasibility of an at-home cognitive rehabilitation
      program that incorporates both prospective implementation intentions strategies (PRIIS) and
      an existing web-based executive function (EF) computerized cognitive training (CCT) software
      for Veterans with Parkinson's disease (PD) and to collect pilot data to determine the impact
      of this program on cognition and everyday function. The central hypothesis is that CCT+PRIIS,
      compared to CCT alone and an active control group, will lead to greater improvements in
      cognitive performance and daily function. This innovative study uses a set of on-line
      training games that target aspects of EF susceptible in PD and trains the transfer of
      cognitive benefits to everyday function, using PRIIS, for Veterans with PD and mild cognitive
      impairment in executive function. Additionally, training is conducted at home allowing for
      convenience and flexibility for participants.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized control trial. three arms to the study
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: change in NIH sponsored Executive Abilities: Measures and Instruments for neurobehavioral evaluation and re-search (NIH-EXAMINER) executive composite score
time frame: week 0 (before intervention begins), 8 weeks, 12 weeks
description: The NIH-EXAMINER has an established 3-factor model defined by (1) cognitive control, (2) working memory (3) fluency. A confirmatory factor analysis indicates these 3-factors load on to 1-factor: executive composite score. Seven tests in the NIH-EXAMINER will be used to compute the composite score
arm group label: cognitive and memory strategy training
arm group type: Experimental
description: The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish.
arm group label: cognitive and memory strategy control training
arm group type: Active Comparator
description: The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish.
arm group label: active control for cognitive and memory strategy training
arm group type: Active Comparator
description: The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish.
intervention type: Behavioral
intervention name: cognitive training
description: Cognitive training consists of a set of computerize games played on an iPad at home. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours.
arm group label: cognitive and memory strategy control training
arm group label: cognitive and memory strategy training
intervention type: Behavioral
intervention name: active control cognitive training
description: The active control consists of a set of computerized games played on an iPad. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours.
arm group label: active control for cognitive and memory strategy training
intervention type: Behavioral
intervention name: memory strategy training
description: the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish.
arm group label: cognitive and memory strategy training
intervention type: Behavioral
intervention name: memory strategy training
description: the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish.
arm group label: active control for cognitive and memory strategy training
arm group label: cognitive and memory strategy control training
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Sandra L. Kletzel, PhD BA
role: Principal Investigator
affiliation: Edward Hines Jr. VA Hospital, Hines, IL
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Cognitive Dysfunction
sharing ipd: Yes
ipd description: Raw and/or normalized data will be made available in the form of Excel files.
ipd time frame: Final data sets will be made available as per Hines VA Hospital local policy for long term storage and access until enterprise-level resources become available.
ipd access criteria: These data will be available upon request by researchers and scientists in accordance with federal guidelines and Hines local policy.
provided document: 