<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/NCT02999516</url>
  </required_header>
  <id_info>
    <org_study_id>CULaSalle</org_study_id>
    <nct_id>NCT02999516</nct_id>
  </id_info>
  <brief_title>Complex Motor Learning With Motor Imaginary</brief_title>
  <official_title>Complex Motor Learning With Motor Imaginary</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Universitario La Salle</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro Universitario La Salle</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Subjects participate in a motor learning training with a special bicycle. The experimental&#xD;
      group proceed with 15 minutes of physical training with the bicycle and 15 minutes of rest&#xD;
      where they use motor imaginary. The control group proceed equal except for the motor&#xD;
      imaginary intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects participate in a motor learning training with a special bicycle. The experimental&#xD;
      group proceed with 15 minutes of physical training with the bicycle and 15 minutes of rest&#xD;
      where they use motor imaginary. The control group proceed equal except for the motor&#xD;
      imaginary intervention.&#xD;
&#xD;
      Participants will be controlled for vestibular system previous participation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time</measure>
    <time_frame>immediately during the intervention</time_frame>
    <description>Minutes of time when the task is learned</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Learning Disturbance</condition>
  <arm_group>
    <arm_group_label>Motor imaginary</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention with Motor imaginary with video</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non Motor imaginary</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention with Rest without motor imaginary</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tDCS stimulation during 20 minutes in the motor cortex.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tDCS sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>tDCS stimulation during 30 seconds in the motor cortex and then 19 minutes and 30 seconds without any stimulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neurofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EEG monitoring in real time with positive feedback in the computer screen when participants motor cortex is activated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neurofeedback sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>EEG monitoring in real time with randomized feedback in the computer screen despite the motor cortex activation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Motor imaginary</intervention_name>
    <description>Participants imagine doing a motor task watching a video recording</description>
    <arm_group_label>Motor imaginary</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non Motor imaginary</intervention_name>
    <description>Participants watch a television documentary</description>
    <arm_group_label>Non Motor imaginary</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>tDCS</intervention_name>
    <description>transcranial direct current stimulation (tDCS) stimulation during 20 minutes in the motor cortex (bilaterally) at 1mA of intensity.</description>
    <arm_group_label>tDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>tDCS sham</intervention_name>
    <description>tDCS stimulation during 30 seconds in the motor cortex (bilaterally) at 1mA of intensity and then 19 minutes and 30 seconds without any stimulation.</description>
    <arm_group_label>tDCS sham</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neurofeedback</intervention_name>
    <description>EEG monitoring of the cerebral cortex in real time with positive feedback in the computer screen when participants motor cortex is activated. The positive feedback consist in an object that moves to the top of the screen when activation occurs in the motor cortex. This task last during 20 minutes.</description>
    <arm_group_label>Neurofeedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neurofeedback sham</intervention_name>
    <description>EEG monitoring of the cerebral cortex in real time with randomized feedback in the computer screen despite motor cortex activation. The positive feedback consist in an object that moves to the top of the screen in a randomized time. This task last during 20 minutes.</description>
    <arm_group_label>Neurofeedback sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 29 years old&#xD;
&#xD;
          -  Asymptomatic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with pain&#xD;
&#xD;
          -  In medical treatment&#xD;
&#xD;
          -  Diagnosed of any disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Daniel Muñoz, PhD</last_name>
    <phone>91401970</phone>
    <phone_ext>309</phone_ext>
    <email>daniel.munoz@lasallecampus.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centro Superior de Estudios Universitarios La Salle</name>
      <address>
        <city>Madrid</city>
        <zip>28660</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Muñoz</last_name>
      <phone>689049424</phone>
      <email>daniel.munoz@lasallecampus.es</email>
    </contact>
    <investigator>
      <last_name>Daniel Muñoz-Garcia, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>July 30, 2018</last_update_submitted>
  <last_update_submitted_qc>July 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro Universitario La Salle</investigator_affiliation>
    <investigator_full_name>Daniel Muñoz-Garcia</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Learning Disabilities</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/NCT02999516
org study id: CULaSalle
nct id: NCT02999516
lead sponsor: 
has dmc: Yes
Subjects participate in a motor learning training with a special bicycle. The experimental
      group proceed with 15 minutes of physical training with the bicycle and 15 minutes of rest
      where they use motor imaginary. The control group proceed equal except for the motor
      imaginary intervention.
Subjects participate in a motor learning training with a special bicycle. The experimental
      group proceed with 15 minutes of physical training with the bicycle and 15 minutes of rest
      where they use motor imaginary. The control group proceed equal except for the motor
      imaginary intervention.

      Participants will be controlled for vestibular system previous participation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Time
time frame: immediately during the intervention
description: Minutes of time when the task is learned
arm group label: Motor imaginary
arm group type: Experimental
description: Intervention with Motor imaginary with video
arm group label: Non Motor imaginary
arm group type: Experimental
description: Intervention with Rest without motor imaginary
arm group label: tDCS
arm group type: Experimental
description: tDCS stimulation during 20 minutes in the motor cortex.
arm group label: tDCS sham
arm group type: Sham Comparator
description: tDCS stimulation during 30 seconds in the motor cortex and then 19 minutes and 30 seconds without any stimulation.
arm group label: Neurofeedback
arm group type: Experimental
description: EEG monitoring in real time with positive feedback in the computer screen when participants motor cortex is activated.
arm group label: Neurofeedback sham
arm group type: Sham Comparator
description: EEG monitoring in real time with randomized feedback in the computer screen despite the motor cortex activation.
intervention type: Other
intervention name: Motor imaginary
description: Participants imagine doing a motor task watching a video recording
arm group label: Motor imaginary
intervention type: Other
intervention name: Non Motor imaginary
description: Participants watch a television documentary
arm group label: Non Motor imaginary
intervention type: Other
intervention name: tDCS
description: transcranial direct current stimulation (tDCS) stimulation during 20 minutes in the motor cortex (bilaterally) at 1mA of intensity.
arm group label: tDCS
intervention type: Other
intervention name: tDCS sham
description: tDCS stimulation during 30 seconds in the motor cortex (bilaterally) at 1mA of intensity and then 19 minutes and 30 seconds without any stimulation.
arm group label: tDCS sham
intervention type: Other
intervention name: Neurofeedback
description: EEG monitoring of the cerebral cortex in real time with positive feedback in the computer screen when participants motor cortex is activated. The positive feedback consist in an object that moves to the top of the screen when activation occurs in the motor cortex. This task last during 20 minutes.
arm group label: Neurofeedback
intervention type: Other
intervention name: Neurofeedback sham
description: EEG monitoring of the cerebral cortex in real time with randomized feedback in the computer screen despite motor cortex activation. The positive feedback consist in an object that moves to the top of the screen in a randomized time. This task last during 20 minutes.
arm group label: Neurofeedback sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Muñoz, PhD
phone: 91401970
phone ext: 309
email: daniel.munoz@lasallecampus.es
facility: 
status: Recruiting
contact: 
investigator: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Centro Universitario La Salle
investigator full name: Daniel Muñoz-Garcia
investigator title: PhD
mesh term: Learning Disabilities
sharing ipd: Undecided