<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/NCT03763344</url>
  </required_header>
  <id_info>
    <org_study_id>19-123</org_study_id>
    <nct_id>NCT03763344</nct_id>
  </id_info>
  <brief_title>An Examination of Visual Perceptual Training</brief_title>
  <official_title>An Examination of Visual Perceptual Training in Older Adults With Subjective Memory Complaints</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Victoria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Victoria</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>
      Perceptual-cognitive training (PCT) is a computerized software game has been shown to improve&#xD;
      sport performance in young elite athletes and even to aid in recovery speeds post-concussion.&#xD;
      PCT may represent a unique type of training that could ultimately enhance cognitive&#xD;
      performance or quality of life in all populations. What is not clear is whether PCT is&#xD;
      beneficial to older adults with subjective memory complaints (SMCs). SMCs in older adults are&#xD;
      an early risk indicator for Alzheimer's disease, making older adults with SMCs a target&#xD;
      population for proactive interventions. The aim of this study was to determine if PCT can&#xD;
      serve as a proactive intervention and enhance cognitive abilities in older adults with SMCs.&#xD;
      The results of this research protocol introduce a new way of prevention from cognitive&#xD;
      decline in healthy older adults and may introduce a new training programs for age-related&#xD;
      memory disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was approved by the University of Victoria Human Research Ethics Board (Protocol&#xD;
      Number 17-167) and all participants provided their informed written consent prior to&#xD;
      participating in this study. In order to reduce the placebo effect, the participants were&#xD;
      randomly divided into the experimental and control groups. Participants from both the&#xD;
      experimental and control groups received a total of three neuropsychological assessments over&#xD;
      a three month period (i.e. baseline, 7 weeks, 11 weeks). Considering that an essential&#xD;
      methodological component of the training studies is the use of standardized&#xD;
      neuropsychological tests, validated and reliable measures such as STROOP TEST, DIGIT SPAN&#xD;
      TEST, TRAIL MAKING TEST, VERBAL FLUENCY TESTS, CALIFORNIA VERBAL LEARNING TEST Second Edition&#xD;
      (i.e., standard and alternate forms), were used at different time points. Each assessment was&#xD;
      50-60 minutes in duration and was administered by an expert neuropsychology resident. The&#xD;
      first assessment was administered at baseline . Then, the experimental group underwent seven&#xD;
      weeks of perceptual cognitive training, while the control group completed seven weeks without&#xD;
      formal training. The treatment for the PCT group consisted of 14 sessions of training each&#xD;
      lasting 25-30 min, twice per week for seven weeks. After the seven-week time period, a second&#xD;
      neuropsychological assessment was performed on both groups. After eleven weeks, a follow-up&#xD;
      assessment was conducted to verify whether the benefits of cognitive training endure over&#xD;
      time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 28, 2017</start_date>
  <completion_date type="Actual">July 15, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in memory performance in older adults with SMCs</measure>
    <time_frame>First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).</time_frame>
    <description>Assessed by CALIFORNIA VERBAL LEARNING TEST</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in processing speed in older adults with SMCs</measure>
    <time_frame>First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).</time_frame>
    <description>Assessed by Delis-Kaplan Executive Function System™ (D-KEFS™).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive flexibility in older adults with SMCs</measure>
    <time_frame>First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).</time_frame>
    <description>Assessed by Delis-Kaplan Executive Function System™ (D-KEFS™)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive flexibility in older adults with SMCs</measure>
    <time_frame>First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).</time_frame>
    <description>Assessed by Stroop Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in working memory in in older adults with SMCs</measure>
    <time_frame>First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).</time_frame>
    <description>Assessed by Digit Span Test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Age-Related Memory Disorders</condition>
  <arm_group>
    <arm_group_label>Cohort C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Older adults over the age of 60 years old with subjective memory complaints that underwent:&#xD;
the first cognitive assessment (Baseline),&#xD;
intervention is fourteen sessions of Perceptual Cognitive Training (PCT) for seven weeks,&#xD;
a post-treatment cognitive assessment (Week 7), and&#xD;
a follow up cognitive assessment (Week 11)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort D</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Older adults over the age of 60 years old with subjective memory complaints that underwent:&#xD;
the first cognitive assessment (baseline),&#xD;
seven weeks of no intervention,&#xD;
a post-treatment cognitive assessment (week 7), and&#xD;
a follow up cognitive assessment (week 11)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Perceptual Cognitive Training (PCT)</intervention_name>
    <description>Perceptual Cognitive Training (PCT) will be performed by having individuals work with a visual perceptual training software program called NeuroTracker. This device uses Multiple Object Tracking at increasing difficulties to develop high-level brain functions critical to recovery &amp; cognitive health. By increasing in difficulty with each correct response and decreasing in difficulty when mistakes are made, brain function is constantly challenged. Each session (6 mins) delivers a series of mini-tests where the patient needs to remember key targets, then track them moving among distractors for several seconds and then identify them. Simple to do, but always challenging, NeuroTracker adaptively optimizes difficulty to each patient's level, maximizing cognitive stimulation every step of the way.</description>
    <arm_group_label>Cohort C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 60 and over;&#xD;
&#xD;
          -  Have subjective cognitive complaints;&#xD;
&#xD;
          -  The results of the screening test Mini Mental State Examination (MMSE) should be ≥ 24&#xD;
             (this test is used only at baseline visit to verify if the participant might be&#xD;
             included in the sample or not).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of medical diagnosis of a Major Neurocognitive Disorder (e.g. Alzheimer's&#xD;
             disease, front temporal lobe dementia, Lewy Body dementia, vascular dementia),&#xD;
&#xD;
          -  Presence of sensory deficits (e.g. colour blindness, monocular/binocular blindness,&#xD;
             macular degeneration),&#xD;
&#xD;
          -  Presence of psychiatric disorders (i.e. depression, anxiety),&#xD;
&#xD;
          -  The participants with scores under 24 at MMSE screening test will be excluded and sent&#xD;
             to the family doctor (i.e. to minimize the risk of including people with pre-clinical&#xD;
             dementia).&#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>Brian R. Christie, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Victoria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Victoria</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8P5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Berry AS, Zanto TP, Clapp WC, Hardy JL, Delahunt PB, Mahncke HW, Gazzaley A. The influence of perceptual training on working memory in older adults. PLoS One. 2010 Jul 14;5(7):e11537. doi: 10.1371/journal.pone.0011537.</citation>
    <PMID>20644719</PMID>
  </reference>
  <reference>
    <citation>Anguera JA, Boccanfuso J, Rintoul JL, Al-Hashimi O, Faraji F, Janowich J, Kong E, Larraburo Y, Rolle C, Johnston E, Gazzaley A. Video game training enhances cognitive control in older adults. Nature. 2013 Sep 5;501(7465):97-101. doi: 10.1038/nature12486.</citation>
    <PMID>24005416</PMID>
  </reference>
  <reference>
    <citation>Cavanagh P, Alvarez GA. Tracking multiple targets with multifocal attention. Trends Cogn Sci. 2005 Jul;9(7):349-54. doi: 10.1016/j.tics.2005.05.009.</citation>
    <PMID>15953754</PMID>
  </reference>
  <reference>
    <citation>Parsons B, Magill T, Boucher A, Zhang M, Zogbo K, Berube S, Scheffer O, Beauregard M, Faubert J. Enhancing Cognitive Function Using Perceptual-Cognitive Training. Clin EEG Neurosci. 2016 Jan;47(1):37-47. doi: 10.1177/1550059414563746. Epub 2014 Dec 30.</citation>
    <PMID>25550444</PMID>
  </reference>
  <reference>
    <citation>Tullo D, Guy J, Faubert J, Bertone A. Training with a three-dimensional multiple object-tracking (3D-MOT) paradigm improves attention in students with a neurodevelopmental condition: a randomized controlled trial. Dev Sci. 2018 Nov;21(6):e12670. doi: 10.1111/desc.12670. Epub 2018 Apr 30.</citation>
    <PMID>29707864</PMID>
  </reference>
  <reference>
    <citation>Faubert J. Visual perception and aging. Can J Exp Psychol. 2002 Sep;56(3):164-76. doi: 10.1037/h0087394.</citation>
    <PMID>12271747</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>October 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 1, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Victoria</investigator_affiliation>
    <investigator_full_name>Brian Christie</investigator_full_name>
    <investigator_title>Professor, CIHR Delegate and Health Research Advisory Committee Chair Division of Medical Sciences,</investigator_title>
  </responsible_party>
  <keyword>memory</keyword>
  <keyword>visual spatial training</keyword>
  <keyword>multiple object tracking</keyword>
  <keyword>Elderly</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Memory Disorders</mesh_term>
  </condition_browse>
  <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/NCT03763344
org study id: 19-123
nct id: NCT03763344
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Perceptual-cognitive training (PCT) is a computerized software game has been shown to improve
      sport performance in young elite athletes and even to aid in recovery speeds post-concussion.
      PCT may represent a unique type of training that could ultimately enhance cognitive
      performance or quality of life in all populations. What is not clear is whether PCT is
      beneficial to older adults with subjective memory complaints (SMCs). SMCs in older adults are
      an early risk indicator for Alzheimer's disease, making older adults with SMCs a target
      population for proactive interventions. The aim of this study was to determine if PCT can
      serve as a proactive intervention and enhance cognitive abilities in older adults with SMCs.
      The results of this research protocol introduce a new way of prevention from cognitive
      decline in healthy older adults and may introduce a new training programs for age-related
      memory disorder.
This study was approved by the University of Victoria Human Research Ethics Board (Protocol
      Number 17-167) and all participants provided their informed written consent prior to
      participating in this study. In order to reduce the placebo effect, the participants were
      randomly divided into the experimental and control groups. Participants from both the
      experimental and control groups received a total of three neuropsychological assessments over
      a three month period (i.e. baseline, 7 weeks, 11 weeks). Considering that an essential
      methodological component of the training studies is the use of standardized
      neuropsychological tests, validated and reliable measures such as STROOP TEST, DIGIT SPAN
      TEST, TRAIL MAKING TEST, VERBAL FLUENCY TESTS, CALIFORNIA VERBAL LEARNING TEST Second Edition
      (i.e., standard and alternate forms), were used at different time points. Each assessment was
      50-60 minutes in duration and was administered by an expert neuropsychology resident. The
      first assessment was administered at baseline . Then, the experimental group underwent seven
      weeks of perceptual cognitive training, while the control group completed seven weeks without
      formal training. The treatment for the PCT group consisted of 14 sessions of training each
      lasting 25-30 min, twice per week for seven weeks. After the seven-week time period, a second
      neuropsychological assessment was performed on both groups. After eleven weeks, a follow-up
      assessment was conducted to verify whether the benefits of cognitive training endure over
      time.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in memory performance in older adults with SMCs
time frame: First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).
description: Assessed by CALIFORNIA VERBAL LEARNING TEST
measure: Change in processing speed in older adults with SMCs
time frame: First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).
description: Assessed by Delis-Kaplan Executive Function System™ (D-KEFS™).
measure: Change in cognitive flexibility in older adults with SMCs
time frame: First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).
description: Assessed by Delis-Kaplan Executive Function System™ (D-KEFS™)
measure: Change in cognitive flexibility in older adults with SMCs
time frame: First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).
description: Assessed by Stroop Test
measure: Change in working memory in in older adults with SMCs
time frame: First neuropsychological assessment (Baseline). After seven week period both groups underwent the second neuropsychological assessment (Week 7). After eleven weeks a follow-up assessment was conducted (Week 11).
description: Assessed by Digit Span Test
arm group label: Cohort C
arm group type: Experimental
description: Older adults over the age of 60 years old with subjective memory complaints that underwent:
the first cognitive assessment (Baseline),
intervention is fourteen sessions of Perceptual Cognitive Training (PCT) for seven weeks,
a post-treatment cognitive assessment (Week 7), and
a follow up cognitive assessment (Week 11)
arm group label: Cohort D
arm group type: No Intervention
description: Older adults over the age of 60 years old with subjective memory complaints that underwent:
the first cognitive assessment (baseline),
seven weeks of no intervention,
a post-treatment cognitive assessment (week 7), and
a follow up cognitive assessment (week 11)
intervention type: Behavioral
intervention name: Perceptual Cognitive Training (PCT)
description: Perceptual Cognitive Training (PCT) will be performed by having individuals work with a visual perceptual training software program called NeuroTracker. This device uses Multiple Object Tracking at increasing difficulties to develop high-level brain functions critical to recovery & cognitive health. By increasing in difficulty with each correct response and decreasing in difficulty when mistakes are made, brain function is constantly challenged. Each session (6 mins) delivers a series of mini-tests where the patient needs to remember key targets, then track them moving among distractors for several seconds and then identify them. Simple to do, but always challenging, NeuroTracker adaptively optimizes difficulty to each patient's level, maximizing cognitive stimulation every step of the way.
arm group label: Cohort C
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Brian R. Christie, Ph.D
role: Principal Investigator
affiliation: University of Victoria
facility: 
country: Canada
citation: Berry AS, Zanto TP, Clapp WC, Hardy JL, Delahunt PB, Mahncke HW, Gazzaley A. The influence of perceptual training on working memory in older adults. PLoS One. 2010 Jul 14;5(7):e11537. doi: 10.1371/journal.pone.0011537.
PMID: 20644719
citation: Anguera JA, Boccanfuso J, Rintoul JL, Al-Hashimi O, Faraji F, Janowich J, Kong E, Larraburo Y, Rolle C, Johnston E, Gazzaley A. Video game training enhances cognitive control in older adults. Nature. 2013 Sep 5;501(7465):97-101. doi: 10.1038/nature12486.
PMID: 24005416
citation: Cavanagh P, Alvarez GA. Tracking multiple targets with multifocal attention. Trends Cogn Sci. 2005 Jul;9(7):349-54. doi: 10.1016/j.tics.2005.05.009.
PMID: 15953754
citation: Parsons B, Magill T, Boucher A, Zhang M, Zogbo K, Berube S, Scheffer O, Beauregard M, Faubert J. Enhancing Cognitive Function Using Perceptual-Cognitive Training. Clin EEG Neurosci. 2016 Jan;47(1):37-47. doi: 10.1177/1550059414563746. Epub 2014 Dec 30.
PMID: 25550444
citation: Tullo D, Guy J, Faubert J, Bertone A. Training with a three-dimensional multiple object-tracking (3D-MOT) paradigm improves attention in students with a neurodevelopmental condition: a randomized controlled trial. Dev Sci. 2018 Nov;21(6):e12670. doi: 10.1111/desc.12670. Epub 2018 Apr 30.
PMID: 29707864
citation: Faubert J. Visual perception and aging. Can J Exp Psychol. 2002 Sep;56(3):164-76. doi: 10.1037/h0087394.
PMID: 12271747
responsible party type: Principal Investigator
investigator affiliation: University of Victoria
investigator full name: Brian Christie
investigator title: Professor, CIHR Delegate and Health Research Advisory Committee Chair Division of Medical Sciences,
mesh term: Memory Disorders
sharing ipd: No