<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/NCT03249961</url>
  </required_header>
  <id_info>
    <org_study_id>175-2017</org_study_id>
    <nct_id>NCT03249961</nct_id>
  </id_info>
  <brief_title>How Many Days Would You Want to Practice a Skill to Achieve it?</brief_title>
  <official_title>How Many Days Would You Want to Practice a Skill to Achieve it?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Practice is required to improve your shot in basketball or to play a musical instrument. The&#xD;
      learning of these motor skills can be further enhanced by non-invasively stimulating regions&#xD;
      of the brain that control movements with electrical currents. These electric currents can&#xD;
      strengthen or weaken connections of the brain, which consequently affects a person's ability&#xD;
      to improve their performance on a skill. Non-invasive brain stimulation (NIBS) is widely&#xD;
      applied in many disciplines of neuroscience research, and has potential therapeutic&#xD;
      application. There are two specific types of NIBS that will be used in this research study:&#xD;
      1) Transcranial Direct Current Stimulation (tDCS), which applies very weak electrical&#xD;
      currents via two rubber electrodes on the scalp, and 2) Transcranial Magnetic Stimulation&#xD;
      (TMS), which applies magnetic pulses via a coil against the head, to stimulate regions of the&#xD;
      brain. Both types of non-invasive brain stimulation (i.e., tDCS, and TMS) are well-tolerated,&#xD;
      painless, and safe. The application of tDCS to brain regions that control movements,&#xD;
      concurrently with practice of a skill, results in better skill performance, than practice&#xD;
      alone with no tDCS. Therefore, in this study, we will be testing different types of brain&#xD;
      stimulation and different amounts of practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 20, 2018</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy</measure>
    <time_frame>Up to 8 days</time_frame>
    <description>Accuracy is defined as the proportion of trials per block with hits to all targets in the correct sequence order.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speed</measure>
    <time_frame>Up to 8 days</time_frame>
    <description>Speed is captured by the average sequence movement time per training block</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Motor Learning</condition>
  <arm_group>
    <arm_group_label>Placebo Brain stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Sham TDCS, and Transcranial Magnetic Stimulation (TMS)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Excitatory Brain Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Anodal TDCS, and Transcranial Magnetic Stimulation (TMS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham TDCS</intervention_name>
    <description>Placebo stimulation is applied to the left motor cortex while participants perform a motor task in the right hand. During the motor task, participants use their right hand to pinch a force transducer that controls an on-screen cursor to navigate between a start position and a sequence of 5 other positions to the right.</description>
    <arm_group_label>Placebo Brain stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Anodal TDCS</intervention_name>
    <description>Excitatory stimulation is applied to the left motor cortex while participants perform a motor task in the right hand. During the motor task, participants use their right hand to pinch a force transducer that controls an on-screen cursor to navigate between a start position and a sequence of 5 other positions to the right.</description>
    <arm_group_label>Excitatory Brain Stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Magnetic Stimulation (TMS)</intervention_name>
    <description>Participants will receive Transcranial Magnetic Stimulation (TMS) to allow research investigators to determine the location of the left motor cortex.</description>
    <arm_group_label>Excitatory Brain Stimulation</arm_group_label>
    <arm_group_label>Placebo Brain stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prior history of neurological or psychiatric disease&#xD;
&#xD;
          -  prior experience with the motor task used&#xD;
&#xD;
          -  contraindications to TMS and TDCS (e.g., metal implants, history of seizures and&#xD;
             headaches)&#xD;
&#xD;
          -  musculoskeletal injury to upper limb&#xD;
&#xD;
          -  drugs that interact with NIBS (e.g., antidepressants, antipsychotics, anticonvulsants)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joyce Chen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Center</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>October 23, 2020</last_update_submitted>
  <last_update_submitted_qc>October 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>motor</keyword>
  <keyword>transcranial direct current stimulation</keyword>
  <keyword>transcranial magnetic stimulation</keyword>
  <!-- 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/NCT03249961
org study id: 175-2017
nct id: NCT03249961
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Practice is required to improve your shot in basketball or to play a musical instrument. The
      learning of these motor skills can be further enhanced by non-invasively stimulating regions
      of the brain that control movements with electrical currents. These electric currents can
      strengthen or weaken connections of the brain, which consequently affects a person's ability
      to improve their performance on a skill. Non-invasive brain stimulation (NIBS) is widely
      applied in many disciplines of neuroscience research, and has potential therapeutic
      application. There are two specific types of NIBS that will be used in this research study:
      1) Transcranial Direct Current Stimulation (tDCS), which applies very weak electrical
      currents via two rubber electrodes on the scalp, and 2) Transcranial Magnetic Stimulation
      (TMS), which applies magnetic pulses via a coil against the head, to stimulate regions of the
      brain. Both types of non-invasive brain stimulation (i.e., tDCS, and TMS) are well-tolerated,
      painless, and safe. The application of tDCS to brain regions that control movements,
      concurrently with practice of a skill, results in better skill performance, than practice
      alone with no tDCS. Therefore, in this study, we will be testing different types of brain
      stimulation and different amounts of practice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Accuracy
time frame: Up to 8 days
description: Accuracy is defined as the proportion of trials per block with hits to all targets in the correct sequence order.
measure: Speed
time frame: Up to 8 days
description: Speed is captured by the average sequence movement time per training block
arm group label: Placebo Brain stimulation
arm group type: Experimental
description: Participants will receive Sham TDCS, and Transcranial Magnetic Stimulation (TMS)
arm group label: Excitatory Brain Stimulation
arm group type: Experimental
description: Participants will receive Anodal TDCS, and Transcranial Magnetic Stimulation (TMS)
intervention type: Device
intervention name: Sham TDCS
description: Placebo stimulation is applied to the left motor cortex while participants perform a motor task in the right hand. During the motor task, participants use their right hand to pinch a force transducer that controls an on-screen cursor to navigate between a start position and a sequence of 5 other positions to the right.
arm group label: Placebo Brain stimulation
intervention type: Device
intervention name: Anodal TDCS
description: Excitatory stimulation is applied to the left motor cortex while participants perform a motor task in the right hand. During the motor task, participants use their right hand to pinch a force transducer that controls an on-screen cursor to navigate between a start position and a sequence of 5 other positions to the right.
arm group label: Excitatory Brain Stimulation
intervention type: Device
intervention name: Transcranial Magnetic Stimulation (TMS)
description: Participants will receive Transcranial Magnetic Stimulation (TMS) to allow research investigators to determine the location of the left motor cortex.
arm group label: Excitatory Brain Stimulation
arm group label: Placebo Brain stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joyce Chen, PhD
role: Principal Investigator
affiliation: Sunnybrook Research Institute
facility: 
country: Canada
responsible party type: Sponsor