<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/NCT03228446</url>
  </required_header>
  <id_info>
    <org_study_id>MD021</org_study_id>
    <nct_id>NCT03228446</nct_id>
  </id_info>
  <brief_title>The Effects of Attentional Filter Training on Working Memory</brief_title>
  <acronym>DIIN</acronym>
  <official_title>Improving Cognitive Functions by Training Distractor Inhibition (DIIN) in Younger and Older Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>German Center for Neurodegenerative Diseases (DZNE)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>German Center for Neurodegenerative Diseases (DZNE)</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>
      The investigators are interested in how attentional filter training/ distractor inhibition&#xD;
      training could influence cognitive functions like working memory, executive control, problem&#xD;
      solving, decision making and attentional control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two different computer based trainings were applied: an attentional filter training and a&#xD;
      working memory training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2012</start_date>
  <completion_date type="Actual">January 2019</completion_date>
  <primary_completion_date type="Actual">December 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvements in test performance</measure>
    <time_frame>45min pre / post</time_frame>
    <description>Working memory and filtering performance (in %), effects of distractor interference and reaction times for trials with and without distractors with 4, 5 &amp; 6 targets</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rey Complex Figure Test</measure>
    <time_frame>30min pre / post</time_frame>
    <description>Copying complex figures and reproduce it from memory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Memory from TAP (Test battery of Attentional Performance)</measure>
    <time_frame>45min pre / post</time_frame>
    <description>Working Memory (n-back)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attention from TAP (Test battery of Attentional Performance)</measure>
    <time_frame>45min pre / post</time_frame>
    <description>divided attention, Go-NoGo, Flexibility, Incompatibility, Visual scanning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance in repeating numbers</measure>
    <time_frame>10min pre / post</time_frame>
    <description>Repeating numbers in forward &amp; backward conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subtest from CANTAB (Cambridge Neuropsychological Test Automated Battery)</measure>
    <time_frame>10min pre / post</time_frame>
    <description>Spatial Span Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iowa Gambling Task</measure>
    <time_frame>5min on each training day (1-5)</time_frame>
    <description>Decision making</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Questionnaires</measure>
    <time_frame>2 min on each training day (1-5)</time_frame>
    <description>subjective performance in the training paradigm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Questionnaires</measure>
    <time_frame>2min on each training day (1-5)</time_frame>
    <description>Assessing external circumstances of daily influences</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Memory performance without distractors among different setsizes</measure>
    <time_frame>45min pre / post</time_frame>
    <description>Working memory performance (in %) for trials with 4, 5 &amp; 6 targets and averaged performance for all conditions without distractors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Memory performance with distractors among different setsizes</measure>
    <time_frame>45min pre / post</time_frame>
    <description>Working memory performance (in %) for trials with 4, 5 &amp; 6 targets and distractors and averaged performance for all conditions with distractors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Filtering performance without distractors among different setsizes</measure>
    <time_frame>45min pre / post</time_frame>
    <description>Filtering performance (in %) for trials with 4, 5 &amp; 6 targets and averaged performance for all conditions without distractors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Filtering performance with distractors among different setsizes</measure>
    <time_frame>45min pre / post</time_frame>
    <description>Filtering performance (in %) for trials with 4, 5 &amp; 6 targets and distractors and averaged performance for all conditions with distractors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reaction times</measure>
    <time_frame>45min pre / post</time_frame>
    <description>Reaction times in each condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Values of distractor inhibition</measure>
    <time_frame>45min pre / post</time_frame>
    <description>Distractor inhibition (DIIN) = Mean of conditions without distractors - Mean of conditions with distractors</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Cognitive Decline</condition>
  <condition>Healthy</condition>
  <condition>Age-related Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>Young subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Working memory training &amp; attentional filter training for participants (18-30 years)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Old subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Working memory training, attentional filter training and no training (control) for participants (60-80 years)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>filter training</intervention_name>
    <description>one-week filter training on the computer: computerized visual change detection experiment (selective attention )</description>
    <arm_group_label>Old subjects</arm_group_label>
    <arm_group_label>Young subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>memory training</intervention_name>
    <description>one-week storage training on the computer: computerized visual change detection experiment (memory storage)</description>
    <arm_group_label>Old subjects</arm_group_label>
    <arm_group_label>Young subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no training (control)</intervention_name>
    <description>no training applied</description>
    <arm_group_label>Old subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  right-hander&#xD;
&#xD;
          -  aged between 18-30 or 60-80years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe visual impairments (e.g. dyschromatopsia, very low vision)&#xD;
&#xD;
          -  diseases or medication that might impair test performance&#xD;
&#xD;
          -  Montreal Cognitive Assessment Score (MoCA) &lt; 26 points&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Notger Müller, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>German Center for Neurodegenerative Diseases (DZNE)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>DZNE</name>
      <address>
        <city>Magdeburg</city>
        <state>Sachsen-Anhalt</state>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>Schmicker M, Schwefel M, Vellage AK, Muller NG. Training of Attentional Filtering, but Not of Memory Storage, Enhances Working Memory Efficiency by Strengthening the Neuronal Gatekeeper Network. J Cogn Neurosci. 2016 Apr;28(4):636-42. doi: 10.1162/jocn_a_00922. Epub 2016 Jan 14.</citation>
    <PMID>26765946</PMID>
  </results_reference>
  <results_reference>
    <citation>Schmicker M, Muller P, Schwefel M, Muller NG. Attentional Filter Training but Not Memory Training Improves Decision-Making. Front Hum Neurosci. 2017 Mar 23;11:138. doi: 10.3389/fnhum.2017.00138. eCollection 2017.</citation>
    <PMID>28386225</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 12, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>German Center for Neurodegenerative Diseases (DZNE)</investigator_affiliation>
    <investigator_full_name>Notger Müller</investigator_full_name>
    <investigator_title>Prof. Dr. med. (Head of Neuroprotection Lab at the DZNE)</investigator_title>
  </responsible_party>
  <keyword>training intervention</keyword>
  <keyword>filter training</keyword>
  <keyword>distractor inhibition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</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/NCT03228446
org study id: MD021
nct id: NCT03228446
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators are interested in how attentional filter training/ distractor inhibition
      training could influence cognitive functions like working memory, executive control, problem
      solving, decision making and attentional control.
Two different computer based trainings were applied: an attentional filter training and a
      working memory training.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Improvements in test performance
time frame: 45min pre / post
description: Working memory and filtering performance (in %), effects of distractor interference and reaction times for trials with and without distractors with 4, 5 & 6 targets
measure: Rey Complex Figure Test
time frame: 30min pre / post
description: Copying complex figures and reproduce it from memory
measure: Memory from TAP (Test battery of Attentional Performance)
time frame: 45min pre / post
description: Working Memory (n-back)
measure: Attention from TAP (Test battery of Attentional Performance)
time frame: 45min pre / post
description: divided attention, Go-NoGo, Flexibility, Incompatibility, Visual scanning
measure: Performance in repeating numbers
time frame: 10min pre / post
description: Repeating numbers in forward & backward conditions
measure: Subtest from CANTAB (Cambridge Neuropsychological Test Automated Battery)
time frame: 10min pre / post
description: Spatial Span Test
measure: Iowa Gambling Task
time frame: 5min on each training day (1-5)
description: Decision making
measure: Daily Questionnaires
time frame: 2 min on each training day (1-5)
description: subjective performance in the training paradigm
measure: Daily Questionnaires
time frame: 2min on each training day (1-5)
description: Assessing external circumstances of daily influences
measure: Memory performance without distractors among different setsizes
time frame: 45min pre / post
description: Working memory performance (in %) for trials with 4, 5 & 6 targets and averaged performance for all conditions without distractors
measure: Memory performance with distractors among different setsizes
time frame: 45min pre / post
description: Working memory performance (in %) for trials with 4, 5 & 6 targets and distractors and averaged performance for all conditions with distractors
measure: Filtering performance without distractors among different setsizes
time frame: 45min pre / post
description: Filtering performance (in %) for trials with 4, 5 & 6 targets and averaged performance for all conditions without distractors
measure: Filtering performance with distractors among different setsizes
time frame: 45min pre / post
description: Filtering performance (in %) for trials with 4, 5 & 6 targets and distractors and averaged performance for all conditions with distractors
measure: Reaction times
time frame: 45min pre / post
description: Reaction times in each condition
measure: Values of distractor inhibition
time frame: 45min pre / post
description: Distractor inhibition (DIIN) = Mean of conditions without distractors - Mean of conditions with distractors
arm group label: Young subjects
arm group type: Experimental
description: Working memory training & attentional filter training for participants (18-30 years)
arm group label: Old subjects
arm group type: Experimental
description: Working memory training, attentional filter training and no training (control) for participants (60-80 years)
intervention type: Behavioral
intervention name: filter training
description: one-week filter training on the computer: computerized visual change detection experiment (selective attention )
arm group label: Old subjects
arm group label: Young subjects
intervention type: Behavioral
intervention name: memory training
description: one-week storage training on the computer: computerized visual change detection experiment (memory storage)
arm group label: Old subjects
arm group label: Young subjects
intervention type: Other
intervention name: no training (control)
description: no training applied
arm group label: Old subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Notger Müller, Prof. Dr.
role: Principal Investigator
affiliation: German Center for Neurodegenerative Diseases (DZNE)
facility: 
country: Germany
citation: Schmicker M, Schwefel M, Vellage AK, Muller NG. Training of Attentional Filtering, but Not of Memory Storage, Enhances Working Memory Efficiency by Strengthening the Neuronal Gatekeeper Network. J Cogn Neurosci. 2016 Apr;28(4):636-42. doi: 10.1162/jocn_a_00922. Epub 2016 Jan 14.
PMID: 26765946
citation: Schmicker M, Muller P, Schwefel M, Muller NG. Attentional Filter Training but Not Memory Training Improves Decision-Making. Front Hum Neurosci. 2017 Mar 23;11:138. doi: 10.3389/fnhum.2017.00138. eCollection 2017.
PMID: 28386225
responsible party type: Principal Investigator
investigator affiliation: German Center for Neurodegenerative Diseases (DZNE)
investigator full name: Notger Müller
investigator title: Prof. Dr. med. (Head of Neuroprotection Lab at the DZNE)
mesh term: Cognitive Dysfunction
sharing ipd: No