<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/NCT03285347</url>
  </required_header>
  <id_info>
    <org_study_id>H-17000220</org_study_id>
    <nct_id>NCT03285347</nct_id>
  </id_info>
  <brief_title>Effect of Computer-based Cognitive Training on Attention and Executive Functions in Patients With Parkinson's Disease</brief_title>
  <official_title>The Effect of Computer-based Cognitive Training on Attention and Executive Functions in Patients With Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bispebjerg Hospital</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 current study adresses the effect of two different computer-based cognitive trianing&#xD;
      programmes on attention and executive functions in patients with Parkinson's disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current study adresses the effect of two different computer-based cognitive training&#xD;
      programmes (Brain+ Evolution and Scientific Brain Training PRO) on attention and executive&#xD;
      functions in patients with Parkinson's disease. The patients are assigned to one of three&#xD;
      groups. Two training groups with each their programme, and a control Group. The training&#xD;
      groups will train at home for 8 weeks with follow-ups every second week. The control group&#xD;
      will not train at home, but will also receive a follow-up with computer-based stimuli&#xD;
      (computerized Card game) every second week, to minimize the possibility that a possible&#xD;
      effect is due to the follow-up's with a professional, and not due to the computer training at&#xD;
      home.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">February 29, 2020</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>Two intervention Groups training with each their computer-based cognitive programme, one control Group receiving no intervention except for the same amount of follow-ups as the two intervention Groups.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Before and after the intervention period, the patients are tested in a neuropsychological battery to asses their executive functioning. The tester is blinded to the Group allocation of the patients.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>SDMT</measure>
    <time_frame>2 minutes</time_frame>
    <description>Symbol digit modalities test, neuropsychological test of processing speed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PDQ-39</measure>
    <time_frame>20 minutes</time_frame>
    <description>Parkinson's disease questionnaire; daily functioning and well-being in Parkinson's disease</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HADS</measure>
    <time_frame>10 minutes</time_frame>
    <description>Hospital anxiety and depression screening</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digit span</measure>
    <time_frame>10 minutes</time_frame>
    <description>Digit span Wais-IV; Working memory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verbal fluency</measure>
    <time_frame>3 minutes</time_frame>
    <description>S-Words, animal-names and A/F-words</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroop colour/word test</measure>
    <time_frame>3 minutes</time_frame>
    <description>Stroop colour/Word test, respone inhibition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail Making A and B</measure>
    <time_frame>5 minutes</time_frame>
    <description>Trail Making A and B, cognitive flexibility</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Executive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Brain+ Evolution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Training with computer-based programme Brain+ Evolution for 8 weeks, receiving follow-ups every second week.&#xD;
Computer-based cognitive training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Scientific Brain Training PRO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Training with computer-based programme Scientific Brain Training PRO for 8 weeks, receiving follow-ups every second week.&#xD;
Computer-based cognitive training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This Group receives no intervention except for the same amount of follow-ups as the two training Groups. This is done to ensure that an effect of training is not aqtually due to the follow-up's with a professional.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Computer-based cognitive training</intervention_name>
    <description>Computer-based cognitive programmes are computer programmes designed as games with the aim of training patients in certain cognitive domains.</description>
    <arm_group_label>Brain+ Evolution</arm_group_label>
    <arm_group_label>Scientific Brain Training PRO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Parkinson's disease AND&#xD;
&#xD;
          -  Montreal cognitive assesment (MOCA)-score between 22-28&#xD;
&#xD;
          -  Motorically cabable of using an iPad&#xD;
&#xD;
          -  Not receiving antipsychotic medicine&#xD;
&#xD;
          -  No comorbid diseases which might influence the level of executive functioning, for an&#xD;
             example ADHD or acquired brain damage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People without Parkinson's disease&#xD;
&#xD;
          -  Parkinson's patients not included in the above inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Annemette Løkkegaard, Ph.d.</last_name>
    <role>Study Director</role>
    <affiliation>Doctor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bispebjerg Hospital</name>
      <address>
        <city>Copenhagen</city>
        <state>Region Hovedstaden</state>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Katrine Sværke</investigator_full_name>
    <investigator_title>Stud. Psych.</investigator_title>
  </responsible_party>
  <keyword>parkinson</keyword>
  <keyword>executive dysfunction</keyword>
  <keyword>attention</keyword>
  <keyword>computer-based cognitive training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03285347
org study id: H-17000220
nct id: NCT03285347
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current study adresses the effect of two different computer-based cognitive trianing
      programmes on attention and executive functions in patients with Parkinson's disease.
The current study adresses the effect of two different computer-based cognitive training
      programmes (Brain+ Evolution and Scientific Brain Training PRO) on attention and executive
      functions in patients with Parkinson's disease. The patients are assigned to one of three
      groups. Two training groups with each their programme, and a control Group. The training
      groups will train at home for 8 weeks with follow-ups every second week. The control group
      will not train at home, but will also receive a follow-up with computer-based stimuli
      (computerized Card game) every second week, to minimize the possibility that a possible
      effect is due to the follow-up's with a professional, and not due to the computer training at
      home.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two intervention Groups training with each their computer-based cognitive programme, one control Group receiving no intervention except for the same amount of follow-ups as the two intervention Groups.
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
masking description: Before and after the intervention period, the patients are tested in a neuropsychological battery to asses their executive functioning. The tester is blinded to the Group allocation of the patients.
measure: SDMT
time frame: 2 minutes
description: Symbol digit modalities test, neuropsychological test of processing speed
measure: PDQ-39
time frame: 20 minutes
description: Parkinson's disease questionnaire; daily functioning and well-being in Parkinson's disease
measure: HADS
time frame: 10 minutes
description: Hospital anxiety and depression screening
measure: Digit span
time frame: 10 minutes
description: Digit span Wais-IV; Working memory
measure: Verbal fluency
time frame: 3 minutes
description: S-Words, animal-names and A/F-words
measure: Stroop colour/word test
time frame: 3 minutes
description: Stroop colour/Word test, respone inhibition
measure: Trail Making A and B
time frame: 5 minutes
description: Trail Making A and B, cognitive flexibility
arm group label: Brain+ Evolution
arm group type: Experimental
description: Intervention: Training with computer-based programme Brain+ Evolution for 8 weeks, receiving follow-ups every second week.
Computer-based cognitive training.
arm group label: Scientific Brain Training PRO
arm group type: Experimental
description: Intervention: Training with computer-based programme Scientific Brain Training PRO for 8 weeks, receiving follow-ups every second week.
Computer-based cognitive training.
arm group label: Control group
arm group type: No Intervention
description: This Group receives no intervention except for the same amount of follow-ups as the two training Groups. This is done to ensure that an effect of training is not aqtually due to the follow-up's with a professional.
intervention type: Device
intervention name: Computer-based cognitive training
description: Computer-based cognitive programmes are computer programmes designed as games with the aim of training patients in certain cognitive domains.
arm group label: Brain+ Evolution
arm group label: Scientific Brain Training PRO
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Annemette Løkkegaard, Ph.d.
role: Study Director
affiliation: Doctor
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Katrine Sværke
investigator title: Stud. Psych.
mesh term: Parkinson Disease
sharing ipd: Undecided