<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/NCT03293823</url>
  </required_header>
  <id_info>
    <org_study_id>RSRB00067540</org_study_id>
    <nct_id>NCT03293823</nct_id>
  </id_info>
  <brief_title>HARP-Project 1 Cognitive Training</brief_title>
  <official_title>HARP-Project 1 Cognitive Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rochester</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>
      Emerging evidence from social neuroscience suggests that prefrontal cortex (PFC), insular and&#xD;
      anterior cingulate cortex (ACC) regulate social and emotional responses to acute threats to&#xD;
      social connectedness among young adults. Deficient neural reserve or overused neural&#xD;
      compensation resulting from neurodegeneration is commonly observed in these frontal regions&#xD;
      in old age. This aging-related &quot;neural depletion&quot; may have implications for how older adults&#xD;
      respond to social threats, potentially increasing maladaptive emotional and social behavioral&#xD;
      responses, such as social anxiety and social avoidance, which contribute to social&#xD;
      disconnectedness. The central hypothesis is that cognitive deficits and associated&#xD;
      aging-related 'neural depletion' in the frontal regions will contribute to maladaptive&#xD;
      social-emotional responses to a social stressor -- social exclusion. Ultimately, maladaptive&#xD;
      responses to acute social stress, such as social anxiety and avoidance, can compromise social&#xD;
      connectedness by increasing social strain and isolation. The investigators have recently&#xD;
      developed a neuroplasticity-based cognitive training program, called vision-based speed of&#xD;
      processing (VSOP) training, targeting multiple aspects of cognitive capacity (e.g.,&#xD;
      attention, working memory and inhibition) and incorporating the speed component to improve&#xD;
      the efficiency of these cognitive processes. VSOP training also targets several neural&#xD;
      networks seeded in ACC and insular (default mode network) or PFC (the frontal-striatal&#xD;
      network and central executive network). These networks also overlap with neural substrates of&#xD;
      emotion regulation. Notably, VSOP training appears to improve emotion regulation, as&#xD;
      depressive symptoms were reduced in older adults following VSOP training. Finally, the&#xD;
      autonomic nervous system (ANS), critical to stress adaptation, is regulated by these frontal&#xD;
      regions. The objective of the proposed pilot study is to provide proof-of-concept for the&#xD;
      hypothesis that improvements in older adults' cognitive capacity, frontal regions' neural&#xD;
      efficiency, and ANS function via the VSOP training will be associated with more adaptive&#xD;
      social-emotional response to social exclusion, which, in turn, should confer longer-term&#xD;
      protection for older adults' sense of social connectedness. Randomized Controlled Trial&#xD;
      Design: 30 older adults will be randomly assigned to engage in 6-week VSOP training, or to an&#xD;
      active control group. Differential changes from baseline to post-training in cognitive&#xD;
      capacity, neural efficiency, and ANS function, and sense of social connectedness, will be&#xD;
      compared between VSOP control groups. A social exclusion paradigm ('cyberball' task) will be&#xD;
      conducted post-training to evaluate VSOP training effects on social-emotional responses to&#xD;
      social exclusion, including anxiety and motivation for social affiliation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 4, 2017</start_date>
  <completion_date type="Actual">December 14, 2018</completion_date>
  <primary_completion_date type="Actual">December 14, 2018</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>6-week cognitive training group vs. an active control group</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants will not be informed whether it is an intervention or control group; instead they will be informed they will receive a computerized cognitive intervention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>cognitive capacity</measure>
    <time_frame>baseline and 7 week post-training</time_frame>
    <description>change of executive function from baseline to 7 week post-training</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>brain function 1 (BOLD fMRI)</measure>
    <time_frame>baseline and 7 week post-training</time_frame>
    <description>brain functional change in response to social scenario task from baseline to 7 week post-training</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>social well-being</measure>
    <time_frame>baseline and 7 week post-training</time_frame>
    <description>change of social well-being measured by HARP Social Connectedness and Well-Being Core Battery from baseline to 7 week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>brain function 2 (BOLD fMRI)</measure>
    <time_frame>7 week post-training only</time_frame>
    <description>brain functional adaptability to cyberball task</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Aging</condition>
  <condition>Social Isolation</condition>
  <arm_group>
    <arm_group_label>vision-based speed of processing (VSOP) cognitive training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>use the INSIGHT online program (Posit Science), which includes five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>active control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The standardized computerized leisure activities program - MLA, including crossword puzzle, Sudoku, etc. will be used</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>VSOP training</intervention_name>
    <description>a computerized cognitive training of attention and processing speed</description>
    <arm_group_label>vision-based speed of processing (VSOP) cognitive training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MLA control</intervention_name>
    <description>a computerized cognitive intervention of multiple mental leisure activities</description>
    <arm_group_label>active control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. aged ≥ 60 years, community-dwelling, English-speaking, adequate vision and hearing for&#xD;
             testing, capacity to give consent based on clinician assessment;&#xD;
&#xD;
          2. Telephone Interview for Cognitive Status (TICS) ≥ 31, Geriatric Depression Scale &lt; 7&#xD;
             (i.e., free of major depression that can interfere with neural efficiency for&#xD;
             social-emotional regulation), EXAMINER composite score (a comprehensive executive&#xD;
             function battery test package that is sensitive to frontal regions' neural efficiency&#xD;
             change) &lt; .70 (i.e., reflecting decreased neural efficiency of frontal regions&#xD;
             compared to cognitively health older adults in general);&#xD;
&#xD;
          3. moderate social relation difficulties: identified by World Health Organization&#xD;
             Disability Assessment Scale (WHO-DAS), &quot;Getting Along with Other People&quot; domain, at&#xD;
             least &quot;moderate&quot; difficulties endorsed; from HARP Database Project screening)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. a self-report clinical diagnosis of dementia or mild cognitive impairment;&#xD;
&#xD;
          2. MRI contraindications (e.g., pacemaker, metallic implant, claustrophobia);&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne Corriveau</last_name>
    <role>Study Director</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Northfield</name>
      <address>
        <city>Fairport</city>
        <state>New York</state>
        <zip>14450</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Highlands</name>
      <address>
        <city>Pittsford</city>
        <state>New York</state>
        <zip>14534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>River Edge Manor</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Johns Meadows</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>July 1, 2019</last_update_submitted>
  <last_update_submitted_qc>July 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Vankee Lin</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03293823
org study id: RSRB00067540
nct id: NCT03293823
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Emerging evidence from social neuroscience suggests that prefrontal cortex (PFC), insular and
      anterior cingulate cortex (ACC) regulate social and emotional responses to acute threats to
      social connectedness among young adults. Deficient neural reserve or overused neural
      compensation resulting from neurodegeneration is commonly observed in these frontal regions
      in old age. This aging-related "neural depletion" may have implications for how older adults
      respond to social threats, potentially increasing maladaptive emotional and social behavioral
      responses, such as social anxiety and social avoidance, which contribute to social
      disconnectedness. The central hypothesis is that cognitive deficits and associated
      aging-related 'neural depletion' in the frontal regions will contribute to maladaptive
      social-emotional responses to a social stressor -- social exclusion. Ultimately, maladaptive
      responses to acute social stress, such as social anxiety and avoidance, can compromise social
      connectedness by increasing social strain and isolation. The investigators have recently
      developed a neuroplasticity-based cognitive training program, called vision-based speed of
      processing (VSOP) training, targeting multiple aspects of cognitive capacity (e.g.,
      attention, working memory and inhibition) and incorporating the speed component to improve
      the efficiency of these cognitive processes. VSOP training also targets several neural
      networks seeded in ACC and insular (default mode network) or PFC (the frontal-striatal
      network and central executive network). These networks also overlap with neural substrates of
      emotion regulation. Notably, VSOP training appears to improve emotion regulation, as
      depressive symptoms were reduced in older adults following VSOP training. Finally, the
      autonomic nervous system (ANS), critical to stress adaptation, is regulated by these frontal
      regions. The objective of the proposed pilot study is to provide proof-of-concept for the
      hypothesis that improvements in older adults' cognitive capacity, frontal regions' neural
      efficiency, and ANS function via the VSOP training will be associated with more adaptive
      social-emotional response to social exclusion, which, in turn, should confer longer-term
      protection for older adults' sense of social connectedness. Randomized Controlled Trial
      Design: 30 older adults will be randomly assigned to engage in 6-week VSOP training, or to an
      active control group. Differential changes from baseline to post-training in cognitive
      capacity, neural efficiency, and ANS function, and sense of social connectedness, will be
      compared between VSOP control groups. A social exclusion paradigm ('cyberball' task) will be
      conducted post-training to evaluate VSOP training effects on social-emotional responses to
      social exclusion, including anxiety and motivation for social affiliation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 6-week cognitive training group vs. an active control group
primary purpose: Prevention
masking: Single (Participant)
masking description: Participants will not be informed whether it is an intervention or control group; instead they will be informed they will receive a computerized cognitive intervention.
measure: cognitive capacity
time frame: baseline and 7 week post-training
description: change of executive function from baseline to 7 week post-training
measure: brain function 1 (BOLD fMRI)
time frame: baseline and 7 week post-training
description: brain functional change in response to social scenario task from baseline to 7 week post-training
measure: social well-being
time frame: baseline and 7 week post-training
description: change of social well-being measured by HARP Social Connectedness and Well-Being Core Battery from baseline to 7 week
measure: brain function 2 (BOLD fMRI)
time frame: 7 week post-training only
description: brain functional adaptability to cyberball task
arm group label: vision-based speed of processing (VSOP) cognitive training
arm group type: Experimental
description: use the INSIGHT online program (Posit Science), which includes five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
arm group label: active control
arm group type: Active Comparator
description: The standardized computerized leisure activities program - MLA, including crossword puzzle, Sudoku, etc. will be used
intervention type: Behavioral
intervention name: VSOP training
description: a computerized cognitive training of attention and processing speed
arm group label: vision-based speed of processing (VSOP) cognitive training
intervention type: Behavioral
intervention name: MLA control
description: a computerized cognitive intervention of multiple mental leisure activities
arm group label: active control
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anne Corriveau
role: Study Director
affiliation: University of Rochester
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Vankee Lin
investigator title: Assistant Professor
sharing ipd: No