<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/NCT04493996</url>
  </required_header>
  <id_info>
    <org_study_id>48/20</org_study_id>
    <nct_id>NCT04493996</nct_id>
  </id_info>
  <brief_title>Increasing Preoperative Cognitive Reserve to Prevent Postoperative Cognitive Dysfunction in Cardiac Surgical Patients</brief_title>
  <acronym>INCORE</acronym>
  <official_title>Increasing Preoperative Cognitive Reserve to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients. A Randomized Controlled Trial on Cognitive Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heart and Brain Research Group, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heart and Brain Research Group, Germany</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>
      Postoperative delirium (POD) and postoperative cognitive decline (POCD) can be observed after&#xD;
      cardiosurgical interventions. Taken together, these postoperative neurocognitive dysfunctions&#xD;
      contribute to increased morbidity and mortality and higher economic costs. Preoperative risk&#xD;
      factors of postoperative neurocognitive dysfunctions, such as decreased neuropsychometric&#xD;
      performance or decreased cognitive daily activities, can be interpreted as reduced cognitive&#xD;
      reserve. The aim of this study is to build up cognitive reserves to protect against the&#xD;
      development of POD and POCD through preoperative, home-based, cognitive training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The planned research project is a monocentric, 2-arm randomized controlled intervention study&#xD;
      involving 100 patients undergoing elective cardiac surgery with extracorporeal circulation.&#xD;
      Patients will be assigned to a training group or control group. The intervention involves a&#xD;
      standardized, paper-and-pencil-based cognitive training that will be performed by the&#xD;
      patients at home for approximately 40 minutes per day over a preoperative period of 2-3&#xD;
      weeks. The control group will receive neither cognitive training nor a placebo intervention.&#xD;
      A detailed assessment of psychological functions will be performed approximately 2-3 weeks&#xD;
      before the start of training, at the end of the training, during hospitalization, at&#xD;
      discharge from the acute clinic, and 3 months after surgery. The primary objective of this&#xD;
      study is to investigate the interventional effect of preoperative cognitive training on the&#xD;
      incidence of POD during the stay in the acute clinic, the incidence of POCD at the time of&#xD;
      discharge from the acute clinic, and 3 months after surgery. Secondary objectives are to&#xD;
      determine the training effect on objective cognitive functions before the surgery and&#xD;
      subjective cognitive functions, as well as health-related quality of life 3 months after&#xD;
      surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 14, 2020</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">November 2023</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>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with postoperative cognitive decline at 3 months after surgery, defined as a decrease between pre- and postoperative examinations of one standard deviation in at least 20% of all objective neuropsychological parameters</measure>
    <time_frame>Immediately pre-training to 3 month post-surgery</time_frame>
    <description>The objective neuropsychological parameters measure cognitive domains like Immediate memory span, free recall, recognition memory, selective attention, working memory, inhibition and word fluency. These cognitive domains will be measured with the following instruments: &quot;Verbaler Lern- und Merkfähigkeitstest&quot; (VLMT), &quot;Brief Visuospatial Memory Test-Revised&quot; (BVMT-R), &quot;Trail Making Test A/B&quot; (TMT), &quot;Letter Number Span Test&quot; (LNS), &quot;Regensburger Wortflüssigkeits-Test&quot; (RWT), and &quot;Syndrom-Kurz Test&quot; (SKT-7).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with postoperative cognitive decline at the time of discharge from the acute clinic, defined as a decrease between the pre- and postoperative examinations of one standard deviation measured with the &quot;Montreal Cognitive Assessment&quot;</measure>
    <time_frame>Immediately pre-training to approximately 1 week post-surgery</time_frame>
    <description>The &quot;Montreal Cognitive Assessment&quot; (MOCA) is a screening procedure for general cognitive function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with postoperative delirium during the stay in the intensive care unit as assessed using the &quot;Intensive Care Delirium Screening Checklist&quot; (ICDSC)</measure>
    <time_frame>Immediately post-surgery to approximately 1-2 days post-surgery</time_frame>
    <description>Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in the intensive care unit. The &quot;Intensive Care Delirium Screening Checklist&quot; (ICDSC) record the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation, speech, and changing symptoms by observing behavior and asking concrete questions to the patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with postoperative delirium during the stay on normal ward as assessed using the &quot;Confusion Assessment Method&quot; (3D-CAM)</measure>
    <time_frame>Approximately 1 week (Immediately post-intensive care unit to approximately 1 week post-intensive care unit)</time_frame>
    <description>Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in an intensive care unit or normal ward. The &quot;Confusion Assessment Method&quot; (3D-CAM) record the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation, speech, and changing symptoms by observing behavior and asking concrete questions to the patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline cognitive failures in everyday life at 3 months after surgery as assessed using the &quot;Cognitive Failures Questionnaire&quot; (CFQ)</measure>
    <time_frame>Immediately pre-training to 3 month post-surgery</time_frame>
    <description>The &quot;Cognitive Failures Questionnaire&quot; (CFQ) measure the frequency of failures in daily living in terms of memory, attention, action, and perception.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline health-related quality of life at 3 months after surgery as assessed using the &quot;36-Item Short Form Health Survey&quot; (SF36)</measure>
    <time_frame>Immediately pre-training to 3 month post-surgery</time_frame>
    <description>The &quot;36-Item Short Form Health Survey&quot; (SF36) includes 36 questions covering 8 health-related factors: vitality, physical functioning, bodily pain, general health perception, physical role function, emotional role function, social role functioning, and mental health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline visual immediate memory span at the end of cognitive training as assessed using the &quot;Brief Visuospatial Memory Test-Revised&quot; (BVMT-R)</measure>
    <time_frame>Immediately pre-training to approximately 2-3 weeks post-training</time_frame>
    <description>In the &quot;Brief Visuospatial Memory Test-Revised&quot; (BVMT-R), the patient is shown six geometric figures for 10 seconds on a DIN A4 sheet of paper, which are to be drawn directly afterward. This procedure is repeated with the same figures in a total of three learning trials. The figures are to be freely replicated in a time-delayed episode with following recognition help.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline visual free recall at the end of cognitive training as assessed using the &quot;Brief Visuospatial Memory Test-Revised&quot; (BVMT-R)</measure>
    <time_frame>Immediately pre-training to approximately 2-3 weeks post-training</time_frame>
    <description>In the &quot;Brief Visuospatial Memory Test-Revised&quot; (BVMT-R), the patient is shown six geometric figures for 10 seconds on a DIN A4 sheet of paper, which are to be drawn directly afterward. This procedure is repeated with the same figures in a total of three learning trials. The figures are to be freely replicated in a time-delayed episode with following recognition help.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline visual recognition memory at the end of cognitive training as assessed using the &quot;Brief Visuospatial Memory Test-Revised&quot; (BVMT-R)</measure>
    <time_frame>Immediately pre-training to approximately 2-3 weeks post-training</time_frame>
    <description>In the &quot;Brief Visuospatial Memory Test-Revised&quot; (BVMT-R), the patient is shown six geometric figures for 10 seconds on a DIN A4 sheet of paper, which are to be drawn directly afterward. This procedure is repeated with the same figures in a total of three learning trials. The figures are to be freely replicated in a time-delayed episode with following recognition help.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline verbal immediate memory span at the end of cognitive training as assessed using the &quot;Verbaler Lern- und Merkfähigkeitstest&quot; (VLMT)</measure>
    <time_frame>Immediately pre-training to approximately 2-3 weeks post-training</time_frame>
    <description>In the &quot;Verbaler Lern- und Merkfähigkeitstest&quot; (VLMT), a list of words is learned over five learning trials, which, after a interference word list, is to be remembered directly and with a delay of about 20 minutes. With subsequent recognition help, the verbal discrimination ability is measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline verbal free recall at the end of cognitive training as assessed using the &quot;Verbaler Lern- und Merkfähigkeitstest&quot; (VLMT)</measure>
    <time_frame>Immediately pre-training to approximately 2-3 weeks post-training</time_frame>
    <description>In the &quot;Verbaler Lern- und Merkfähigkeitstest&quot; (VLMT), a list of words is learned over five learning trials, which, after a interference word list, is to be remembered directly and with a delay of about 20 minutes. With subsequent recognition help, the verbal discrimination ability is measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline verbal recognition memory at the end of cognitive training as assessed using the &quot;Verbaler Lern- und Merkfähigkeitstest&quot; (VLMT)</measure>
    <time_frame>Immediately pre-training to approximately 2-3 weeks post-training</time_frame>
    <description>In the &quot;Verbaler Lern- und Merkfähigkeitstest&quot; (VLMT), a list of words is learned over five learning trials, which, after a interference word list, is to be remembered directly and with a delay of about 20 minutes. With subsequent recognition help, the verbal discrimination ability is measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline selective attention at the end of cognitive training as assessed using the &quot;Trail Making Test A&quot; (TMT)</measure>
    <time_frame>Immediately pre-training to approximately 2-3 weeks post-training</time_frame>
    <description>In the &quot;Trail Making Test A&quot; (TMT-A), the patient has to connect numbers in ascending order on a test sheet as fast as possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline verbal working memory at the end of cognitive training as assessed using the &quot;Letter Number Span Test&quot; (LNS)</measure>
    <time_frame>Immediately pre-training to approximately 2-3 weeks post-training</time_frame>
    <description>In the &quot;Letter Number Span Test&quot; (LNS), the patient is supposed to rearrange a mixed sequence of letters and numbers through mental reorganization in such a way that first all numbers and then all letters are to be named in ascending order.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline cognitive flexibility at the end of cognitive training as assessed using the &quot;Trail Making Test B&quot; (TMT)</measure>
    <time_frame>Immediately pre-training to approximately 2-3 weeks post-training</time_frame>
    <description>With the &quot;Trail Making Test B&quot; (TMT-B), the patient's task is to connect numbers and letters alternately in ascending order.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline inhibition at the end of cognitive training as assessed using the &quot;Syndrom-Kurz Test&quot; (SKT-7)</measure>
    <time_frame>Immediately pre-training to approximately 2-3 weeks post-training</time_frame>
    <description>In the &quot;Syndrom-Kurz Test&quot; (SKT-7), the patient has to rename a series of letters (e.g., &quot;A&quot; instead of &quot;B,&quot; and vice versa).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline word fluency at the end of cognitive training as assessed using the &quot;Regensburger Wortflüssigkeits-Test&quot; (RWT)</measure>
    <time_frame>Immediately pre-training to approximately 2-3 weeks post-training</time_frame>
    <description>In the &quot;Regensburger Wortflüssigkeits-Test&quot; (RWT), the patient has to name in one minute as many words as possible from a certain category.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Postoperative Cognitive Decline</condition>
  <condition>Postoperative Delirium</condition>
  <condition>Postoperative Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Cognitive training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive training</intervention_name>
    <description>The cognitive training involves a standardized, paper-and-pencil-based cognitive training that will be performed by the patients at home for approximately 40 minutes per day over a preoperative period of 2-3 weeks</description>
    <arm_group_label>Cognitive training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective cardiac surgery (coronary artery bypass surgery, aortic or mitral valve&#xD;
             replacement/reconstruction, or combination surgery) with standardized extracorporeal&#xD;
             circulation&#xD;
&#xD;
          -  A sufficiently good knowledge of German is necessary as cognitive training and&#xD;
             neuropsychological tests are language-dependent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of stroke and preexisting psychiatric or neurological disorders that may&#xD;
             impair the neuropsychological performance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marius Butz, Dipl.-Psych.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martin Jünemann, Dr.med,M.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinic for Neurology, University Hospital Gießen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tibo Gerriets, Prof.Dr.med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neurology, Gesundheitszentrum Wetterau</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Markus Schönburg, Prof.Dr.med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marius Butz, Dipl.-Psych.</last_name>
    <phone>+496032 996 5812</phone>
    <email>m.butz@kerckhoff-klinik.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Martin Jünemann, Dr.med,M.Sc.</last_name>
    <phone>+49641 98558917</phone>
    <email>Martin.Juenemann@neuro.med.uni-giessen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Cardiac Surgery, Kerckhoff-Klinik GmbH</name>
      <address>
        <city>Bad Nauheim</city>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marius Butz</last_name>
      <phone>+496032 996 5812</phone>
      <email>m.butz@kerckhoff-klinik.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>March 15, 2022</last_update_submitted>
  <last_update_submitted_qc>March 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac Surgery</keyword>
  <keyword>Postoperative Cognitive Decline</keyword>
  <keyword>Postoperative Delirium</keyword>
  <keyword>Cognitive Training</keyword>
  <keyword>Cognitive Reserve</keyword>
  <keyword>Postoperative Cognitive Dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
    <mesh_term>Emergence Delirium</mesh_term>
    <mesh_term>Postoperative Cognitive Complications</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/NCT04493996
org study id: 48/20
nct id: NCT04493996
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Postoperative delirium (POD) and postoperative cognitive decline (POCD) can be observed after
      cardiosurgical interventions. Taken together, these postoperative neurocognitive dysfunctions
      contribute to increased morbidity and mortality and higher economic costs. Preoperative risk
      factors of postoperative neurocognitive dysfunctions, such as decreased neuropsychometric
      performance or decreased cognitive daily activities, can be interpreted as reduced cognitive
      reserve. The aim of this study is to build up cognitive reserves to protect against the
      development of POD and POCD through preoperative, home-based, cognitive training.
The planned research project is a monocentric, 2-arm randomized controlled intervention study
      involving 100 patients undergoing elective cardiac surgery with extracorporeal circulation.
      Patients will be assigned to a training group or control group. The intervention involves a
      standardized, paper-and-pencil-based cognitive training that will be performed by the
      patients at home for approximately 40 minutes per day over a preoperative period of 2-3
      weeks. The control group will receive neither cognitive training nor a placebo intervention.
      A detailed assessment of psychological functions will be performed approximately 2-3 weeks
      before the start of training, at the end of the training, during hospitalization, at
      discharge from the acute clinic, and 3 months after surgery. The primary objective of this
      study is to investigate the interventional effect of preoperative cognitive training on the
      incidence of POD during the stay in the acute clinic, the incidence of POCD at the time of
      discharge from the acute clinic, and 3 months after surgery. Secondary objectives are to
      determine the training effect on objective cognitive functions before the surgery and
      subjective cognitive functions, as well as health-related quality of life 3 months after
      surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Number of participants with postoperative cognitive decline at 3 months after surgery, defined as a decrease between pre- and postoperative examinations of one standard deviation in at least 20% of all objective neuropsychological parameters
time frame: Immediately pre-training to 3 month post-surgery
description: The objective neuropsychological parameters measure cognitive domains like Immediate memory span, free recall, recognition memory, selective attention, working memory, inhibition and word fluency. These cognitive domains will be measured with the following instruments: "Verbaler Lern- und Merkfähigkeitstest" (VLMT), "Brief Visuospatial Memory Test-Revised" (BVMT-R), "Trail Making Test A/B" (TMT), "Letter Number Span Test" (LNS), "Regensburger Wortflüssigkeits-Test" (RWT), and "Syndrom-Kurz Test" (SKT-7).
measure: Number of participants with postoperative cognitive decline at the time of discharge from the acute clinic, defined as a decrease between the pre- and postoperative examinations of one standard deviation measured with the "Montreal Cognitive Assessment"
time frame: Immediately pre-training to approximately 1 week post-surgery
description: The "Montreal Cognitive Assessment" (MOCA) is a screening procedure for general cognitive function.
measure: Number of participants with postoperative delirium during the stay in the intensive care unit as assessed using the "Intensive Care Delirium Screening Checklist" (ICDSC)
time frame: Immediately post-surgery to approximately 1-2 days post-surgery
description: Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in the intensive care unit. The "Intensive Care Delirium Screening Checklist" (ICDSC) record the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation, speech, and changing symptoms by observing behavior and asking concrete questions to the patient.
measure: Number of participants with postoperative delirium during the stay on normal ward as assessed using the "Confusion Assessment Method" (3D-CAM)
time frame: Approximately 1 week (Immediately post-intensive care unit to approximately 1 week post-intensive care unit)
description: Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in an intensive care unit or normal ward. The "Confusion Assessment Method" (3D-CAM) record the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation, speech, and changing symptoms by observing behavior and asking concrete questions to the patient.
measure: Change from baseline cognitive failures in everyday life at 3 months after surgery as assessed using the "Cognitive Failures Questionnaire" (CFQ)
time frame: Immediately pre-training to 3 month post-surgery
description: The "Cognitive Failures Questionnaire" (CFQ) measure the frequency of failures in daily living in terms of memory, attention, action, and perception.
measure: Change from baseline health-related quality of life at 3 months after surgery as assessed using the "36-Item Short Form Health Survey" (SF36)
time frame: Immediately pre-training to 3 month post-surgery
description: The "36-Item Short Form Health Survey" (SF36) includes 36 questions covering 8 health-related factors: vitality, physical functioning, bodily pain, general health perception, physical role function, emotional role function, social role functioning, and mental health.
measure: Change from baseline visual immediate memory span at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)
time frame: Immediately pre-training to approximately 2-3 weeks post-training
description: In the "Brief Visuospatial Memory Test-Revised" (BVMT-R), the patient is shown six geometric figures for 10 seconds on a DIN A4 sheet of paper, which are to be drawn directly afterward. This procedure is repeated with the same figures in a total of three learning trials. The figures are to be freely replicated in a time-delayed episode with following recognition help.
measure: Change from baseline visual free recall at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)
time frame: Immediately pre-training to approximately 2-3 weeks post-training
description: In the "Brief Visuospatial Memory Test-Revised" (BVMT-R), the patient is shown six geometric figures for 10 seconds on a DIN A4 sheet of paper, which are to be drawn directly afterward. This procedure is repeated with the same figures in a total of three learning trials. The figures are to be freely replicated in a time-delayed episode with following recognition help.
measure: Change from baseline visual recognition memory at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)
time frame: Immediately pre-training to approximately 2-3 weeks post-training
description: In the "Brief Visuospatial Memory Test-Revised" (BVMT-R), the patient is shown six geometric figures for 10 seconds on a DIN A4 sheet of paper, which are to be drawn directly afterward. This procedure is repeated with the same figures in a total of three learning trials. The figures are to be freely replicated in a time-delayed episode with following recognition help.
measure: Change from baseline verbal immediate memory span at the end of cognitive training as assessed using the "Verbaler Lern- und Merkfähigkeitstest" (VLMT)
time frame: Immediately pre-training to approximately 2-3 weeks post-training
description: In the "Verbaler Lern- und Merkfähigkeitstest" (VLMT), a list of words is learned over five learning trials, which, after a interference word list, is to be remembered directly and with a delay of about 20 minutes. With subsequent recognition help, the verbal discrimination ability is measured.
measure: Change from baseline verbal free recall at the end of cognitive training as assessed using the "Verbaler Lern- und Merkfähigkeitstest" (VLMT)
time frame: Immediately pre-training to approximately 2-3 weeks post-training
description: In the "Verbaler Lern- und Merkfähigkeitstest" (VLMT), a list of words is learned over five learning trials, which, after a interference word list, is to be remembered directly and with a delay of about 20 minutes. With subsequent recognition help, the verbal discrimination ability is measured.
measure: Change from baseline verbal recognition memory at the end of cognitive training as assessed using the "Verbaler Lern- und Merkfähigkeitstest" (VLMT)
time frame: Immediately pre-training to approximately 2-3 weeks post-training
description: In the "Verbaler Lern- und Merkfähigkeitstest" (VLMT), a list of words is learned over five learning trials, which, after a interference word list, is to be remembered directly and with a delay of about 20 minutes. With subsequent recognition help, the verbal discrimination ability is measured.
measure: Change from baseline selective attention at the end of cognitive training as assessed using the "Trail Making Test A" (TMT)
time frame: Immediately pre-training to approximately 2-3 weeks post-training
description: In the "Trail Making Test A" (TMT-A), the patient has to connect numbers in ascending order on a test sheet as fast as possible.
measure: Change from baseline verbal working memory at the end of cognitive training as assessed using the "Letter Number Span Test" (LNS)
time frame: Immediately pre-training to approximately 2-3 weeks post-training
description: In the "Letter Number Span Test" (LNS), the patient is supposed to rearrange a mixed sequence of letters and numbers through mental reorganization in such a way that first all numbers and then all letters are to be named in ascending order.
measure: Change from baseline cognitive flexibility at the end of cognitive training as assessed using the "Trail Making Test B" (TMT)
time frame: Immediately pre-training to approximately 2-3 weeks post-training
description: With the "Trail Making Test B" (TMT-B), the patient's task is to connect numbers and letters alternately in ascending order.
measure: Change from baseline inhibition at the end of cognitive training as assessed using the "Syndrom-Kurz Test" (SKT-7)
time frame: Immediately pre-training to approximately 2-3 weeks post-training
description: In the "Syndrom-Kurz Test" (SKT-7), the patient has to rename a series of letters (e.g., "A" instead of "B," and vice versa).
measure: Change from baseline word fluency at the end of cognitive training as assessed using the "Regensburger Wortflüssigkeits-Test" (RWT)
time frame: Immediately pre-training to approximately 2-3 weeks post-training
description: In the "Regensburger Wortflüssigkeits-Test" (RWT), the patient has to name in one minute as many words as possible from a certain category.
arm group label: Cognitive training group
arm group type: Experimental
arm group label: Control group
arm group type: No Intervention
intervention type: Behavioral
intervention name: Cognitive training
description: The cognitive training involves a standardized, paper-and-pencil-based cognitive training that will be performed by the patients at home for approximately 40 minutes per day over a preoperative period of 2-3 weeks
arm group label: Cognitive training group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marius Butz, Dipl.-Psych.
role: Principal Investigator
affiliation: Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim
last name: Martin Jünemann, Dr.med,M.Sc.
role: Principal Investigator
affiliation: Clinic for Neurology, University Hospital Gießen
last name: Tibo Gerriets, Prof.Dr.med.
role: Principal Investigator
affiliation: Department of Neurology, Gesundheitszentrum Wetterau
last name: Markus Schönburg, Prof.Dr.med.
role: Principal Investigator
affiliation: Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim
last name: Marius Butz, Dipl.-Psych.
phone: +496032 996 5812
email: m.butz@kerckhoff-klinik.de
last name: Martin Jünemann, Dr.med,M.Sc.
phone: +49641 98558917
email: Martin.Juenemann@neuro.med.uni-giessen.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor
mesh term: Delirium
mesh term: Emergence Delirium
mesh term: Postoperative Cognitive Complications
mesh term: Cognitive Dysfunction