<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/NCT02189564</url>
  </required_header>
  <id_info>
    <org_study_id>KFSP-SUB1-LU13054</org_study_id>
    <nct_id>NCT02189564</nct_id>
  </id_info>
  <brief_title>Rewarding Feedback in Motor Learning and Rehabilitation</brief_title>
  <acronym>KFSP-REWARD</acronym>
  <official_title>Die Auswirkung Von Dopaminergen Belohnungsreizen Auf Das Lernen Einer Motorischen Fertikgeit Bei Gesunden Probanden &quot;Effects of Dopaminergic Reward on Motor Skill Learning in Healthy Subjects&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kai Lutz, PhD</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cereneo AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effect of rewarding vs. non-rewarding feedback on acquisition of a motor skill is&#xD;
      investigated in a single blinded parallel group design. Reward consists of performance&#xD;
      dependent monetary reward, or of knowledge of performance in selected (above average) trials.&#xD;
&#xD;
      The investigators hypothesize improved motor skill learning and higher involvement of the&#xD;
      dopaminsrgic system under rewarding vs. non-rewarding conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Motor skill learning using an arc pointing task</measure>
    <time_frame>about 10 minutes pre-training, about 10 min post training, about 24h post training</time_frame>
    <description>temporal and spacial precision in an arc pointing task will be assessed using 5 different movement speeds during the above mentioned time periods before and after a specific motor learning programm. Learning will be assessed as change from pre-training to post training</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Motor Performance</condition>
  <condition>Motor Learning</condition>
  <arm_group>
    <arm_group_label>Intrinsic reward</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Feedback about good performance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intrinsic and extrinsic reward</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Feedback about good performance + money</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intrinsic reward (average performance)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Feedback about random selection of trials</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Feedback about good performance</intervention_name>
    <arm_group_label>Intrinsic reward</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Feedback about good performance + money</intervention_name>
    <arm_group_label>Intrinsic and extrinsic reward</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Feedback about average performance</intervention_name>
    <arm_group_label>Intrinsic reward (average performance)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  neurologically healthy&#xD;
&#xD;
          -  right handed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications against magnetic resonance imaging&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cereneo, Center For Rehabilitation and Neurology</name>
      <address>
        <city>Vitznau</city>
        <state>Lucerne</state>
        <zip>6354</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>June 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>April 29, 2016</last_update_submitted>
  <last_update_submitted_qc>April 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cereneo AG</investigator_affiliation>
    <investigator_full_name>Kai Lutz, PhD</investigator_full_name>
    <investigator_title>Scientific Director</investigator_title>
  </responsible_party>
  <!-- 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/NCT02189564
org study id: KFSP-SUB1-LU13054
nct id: NCT02189564
lead sponsor: 
collaborator: 
has dmc: No
The effect of rewarding vs. non-rewarding feedback on acquisition of a motor skill is
      investigated in a single blinded parallel group design. Reward consists of performance
      dependent monetary reward, or of knowledge of performance in selected (above average) trials.

      The investigators hypothesize improved motor skill learning and higher involvement of the
      dopaminsrgic system under rewarding vs. non-rewarding conditions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Motor skill learning using an arc pointing task
time frame: about 10 minutes pre-training, about 10 min post training, about 24h post training
description: temporal and spacial precision in an arc pointing task will be assessed using 5 different movement speeds during the above mentioned time periods before and after a specific motor learning programm. Learning will be assessed as change from pre-training to post training
arm group label: Intrinsic reward
arm group type: Active Comparator
description: Feedback about good performance
arm group label: Intrinsic and extrinsic reward
arm group type: Experimental
description: Feedback about good performance + money
arm group label: Intrinsic reward (average performance)
arm group type: Experimental
description: Feedback about random selection of trials
intervention type: Behavioral
intervention name: Feedback about good performance
arm group label: Intrinsic reward
intervention type: Behavioral
intervention name: Feedback about good performance + money
arm group label: Intrinsic and extrinsic reward
intervention type: Behavioral
intervention name: Feedback about average performance
arm group label: Intrinsic reward (average performance)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Cereneo AG
investigator full name: Kai Lutz, PhD
investigator title: Scientific Director