<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/NCT02263092</url>
  </required_header>
  <id_info>
    <org_study_id>Exercise_tdcs_metaplasticity</org_study_id>
    <nct_id>NCT02263092</nct_id>
  </id_info>
  <brief_title>Effects of Transcranial Direct Current Stimulation Associated With Physical Exercise: a Metaplasticity Study</brief_title>
  <official_title>Effects of Transcranial Direct Current Stimulation Associated With Physical Exercise: a Metaplasticity Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal de Pernambuco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal de Pernambuco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to understand metaplasticity through the association of transcranial direct&#xD;
      current stimulation (tDCS) and physical exercise. For this purpose, the study will be&#xD;
      separate in 2 phases: in the first phase the aim is verify the effects of physical exercise&#xD;
      on cortical excitability. After this 1st phase two intensities of physical exercise will be&#xD;
      chosen for the second phase. In the 2nd phase, subjects will undergo to anodal, cathodal and&#xD;
      sham tDCS plus physical exercise.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Before the two phases of the study, the subjects will be evaluate in the following aspects:&#xD;
      anxiety by the beck anxiety inventory; depression by the beck depression inventory; level of&#xD;
      physical exercise by the international physical activity questionnaire; stress by the stress&#xD;
      perceived scale 10.&#xD;
&#xD;
      In the first phase, the subjects will be undergo to 4 conditions: (i) 15 minutes of physical&#xD;
      exercise with moderate intensity; (ii) 10 minutes of physical exercise with high intensity;&#xD;
      (iii) 30 minutes of physical exercise with mild intensity; (iv) 15 or 30 minutes of rest.&#xD;
      Before each condition, cortical excitability will be measure through the Transcranial&#xD;
      magnetic stimulation by motor evoked potential (MEP); the blood glucose level will be&#xD;
      evaluate by glucometer. The MEP also will be done immediately after the physical exercise and&#xD;
      in every 5 min for 30 after the end of exercise/rest. The blood glucose level will be done&#xD;
      immediately after the exercise..&#xD;
&#xD;
      In the second phase, the subjects will be undergo to 6 conditions: (i) anodal tDCS + physical&#xD;
      exercise 1; (ii) anodal tDCS + physical exercise 2; (iii) cathodal tDCS + physical exercise&#xD;
      1; (iv) cathodal tDCS + physical exercise 2; (v) sham tDCS + physical exercise 1; (vi) sham&#xD;
      tDCS + physical exercise 2. The intensity and time of physical exercise depends of the&#xD;
      results of the previous phase and will be determine after the end of phase 1. In this phase,&#xD;
      the blood glucose level will be evaluate before and immediately the physical exercise. The&#xD;
      cortical excitability will be evaluate through the Transcranial magnetic stimulation by the&#xD;
      following measures: motor evoked potential - before the tDCS,after tDCS, immediately , 10,&#xD;
      20, 30, 60, 90 minutes after the exercise; resting motor threshold - before tdcs, immediately&#xD;
      and 90 minutes after the exercise; recruitment curve - before tdcs, immediately and 90&#xD;
      minutes after the exercise.&#xD;
&#xD;
      tDCS condition During tDCS application, patients will be seated in a comfortable chair with&#xD;
      head and arms rests. Current will be applied by a DC stimulator (NeuroConn, Germany) using a&#xD;
      pair of saline-soaked sponge electrodes (surface 35 and 36cm²).&#xD;
&#xD;
      tDCS will be applied to Cz and Oz according to International 10-20 EEG system. In the anodal&#xD;
      tDCS, the anode will be placed in Cz and cathode in Oz. In the cathodal tDCS the inverse&#xD;
      position will be done. Parameters of current intensity and duration (dose) used were&#xD;
      previously established in poststroke patients: 2 mA stimulation intensity for 20 minutes with&#xD;
      current ramping up and down of 10 seconds each.&#xD;
&#xD;
      Sham tDCS has been used in several studies to evaluate the effect of active tDCS. For sham,&#xD;
      the same position of anodal tDCS will be assumed, however, current duration is only 30&#xD;
      seconds, with current ramping up and down of 10 seconds each. Moreover, the&#xD;
      electrostimulation device is automatically turned off without patient's perception. Thus,&#xD;
      patients experience early sensations (mild to moderate tingling) in stimulation site without&#xD;
      inducing effect. Moreover, after each tDCS session, patients will answer adverse effects&#xD;
      questionnaire.&#xD;
&#xD;
      Physical exercise condition The intensity of physical exercise will be determine by the&#xD;
      maximum heart rate (max HR) using the formula (220 - age). For the high intensity, the&#xD;
      intensity will between xx and xx% of maxHR; moderate intensity, 64-76% of maxHR; mild&#xD;
      intensity, 57-63% of maxHR. Furthermore, during the physical exercise the heart rate will be&#xD;
      continuous evaluate by the POLAR and the rate perceived scale will be register in each 3&#xD;
      minutes by the modified Borg scale Outcome measures Evaluation of brain activity will be&#xD;
      performed using single-pulse transcranial magnetic stimulation (TMS-p). Magnetic stimulation&#xD;
      (Neurosoft, Russia) will be applied through a figure-8 coil to determine motor cortex&#xD;
      representation of right tibial anterior muscle (hotspot) and performed the following&#xD;
      electrophysiological measures to assess cortical activity: (i) Motor Evoked Potential (MEP);&#xD;
      (ii) resting motor threshold (RMT) and (iii) Recruitment curve (RC).&#xD;
&#xD;
      Firstly, patients will be instructed to sit in a chair and to search a comfortable position.&#xD;
      The hotspot will be considered the most excitable area, with more intense motor evoked&#xD;
      potential (MEP), measured by electromyography.&#xD;
&#xD;
      The following electrophysiological measures will be performed in left cerebral hemisphere to&#xD;
      assess cortical activity:&#xD;
&#xD;
      (i) Motor Evoked Potential (MEP) : the intensity of magnetic stimulator is adjusted to&#xD;
      produce an average MEP of 0.4 mV. TMS-p will be applied in the area of cortical&#xD;
      representation of the tibial anterior and mean responses to stimuli should reach 0.4 to 0.6&#xD;
      mV.&#xD;
&#xD;
      (ii) Resting motor threshold (RMT) : will be request to the patient to perform contraction of&#xD;
      the tibial anterior muscle and then, will be given ten pulses by TMS-p to determinate resting&#xD;
      motor threshold. Motor threshold corresponds to the lowest intensity of TMS-p to produce a&#xD;
      MEP of 50μV in 50% of the pulses applied to the hotspot.&#xD;
&#xD;
      (iii) Recruitment curve (RC): Five stimuli were applied at each of the following intensities:&#xD;
      5% below resting motor threshold (RMT), RMT, 5% above RMT, 10% above RMT, 20% above RMT, 30%&#xD;
      above RMT, 35% above RMT and at 100% of stimulator output. The five stimuli at each intensity&#xD;
      were delivered in a block, but the order of stimulation intensity changes was random. The&#xD;
      interval between successive TMS stimuli was between 5.5 to 6.5 s.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2014</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">February 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change on cortical excitability - motor evoked potential (MEP)</measure>
    <time_frame>Phase 1 - in each session (every day), baseline and every 5 minutes for 30 minutes after exercise/rest. Phase 2 - in each session (every day), baseline, after, 10, 20, 30, 60 and 90 after tDCS + exercise</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change on cortical excitability - resting motor threshold (RMT)</measure>
    <time_frame>Phase 2 - in each session (every day), baseline, after and 90 after tDCS + exercise</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on cortical excitability - Recruitment curve (RC)</measure>
    <time_frame>Phase 2 - in each session (every day), baseline, after and 90 after tDCS + exercise</time_frame>
  </secondary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Metaplasticity</condition>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>15 minutes of physical exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the subjects will do physical exercise on a treadmill with 64 to 74% of maxHR</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10 minutes of physical exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>- the subjects will do physical exercise on a treadmill with 77 to 95% of maxHR.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>30 minutes of physical exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>- the subjects will do physical exercise on a treadmill with 57 to 63% of maxHR.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rest/control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the subjects will be on 15 or 30 minutes seat without move the legs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anodal tDCS + physical exercise 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the subjects will be undergo to anodal tDCS + physical exercise 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anodal tDCS + physical exercise 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the subjects will be undergo to anodal tDCS + physical exercise 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cathodal tDCS + physical exercise 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the subjects will be undergo to cathodal tDCS + physical exercise 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cathodal tDCS + physical exercise 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>- the subjects will be undergo to cathodal tDCS + physical exercise 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS + physical exercise 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the subjects will be undergo to sham tDCS + physical exercise 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS + physical exercise 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the subjects will be undergo to sham tDCS + physical exercise 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical exercise</intervention_name>
    <description>The intensity of physical exercise will be determine by the maximum heart rate (max HR) using the formula (220 - age). For the high intensity, the intensity will between 79-95% xx% of maxHR; moderate intensity, 64-76% of maxHR; mild intensity, 57-63% of maxHR. Furthermore, during the physical exercise the heart rate will be continuous evaluate by the POLAR and the rate perceived scale will be register in each 3 minutes by the modified Borg scale</description>
    <arm_group_label>10 minutes of physical exercise</arm_group_label>
    <arm_group_label>15 minutes of physical exercise</arm_group_label>
    <arm_group_label>30 minutes of physical exercise</arm_group_label>
    <arm_group_label>Anodal tDCS + physical exercise 1</arm_group_label>
    <arm_group_label>Anodal tDCS + physical exercise 2</arm_group_label>
    <arm_group_label>Cathodal tDCS + physical exercise 1</arm_group_label>
    <arm_group_label>Cathodal tDCS + physical exercise 2</arm_group_label>
    <arm_group_label>Sham tDCS + physical exercise 1</arm_group_label>
    <arm_group_label>Sham tDCS + physical exercise 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS</intervention_name>
    <description>Current will be applied by a DC stimulator (NeuroConn, Germany) using a pair of saline-soaked sponge electrodes (surface 35 and 36cm²). tDCS will be applied to Cz and Oz according to International 10-20 EEG system. In the anodal tDCS, the anode will be placed in Cz and cathode in Oz. In the cathodal tDCS the inverse position will be done. Parameters of current intensity and duration (dose) used were 2 mA stimulation intensity for 20 minutes with current ramping up and down of 10 seconds each.For sham, the same position of anodal tDCS will be assumed, however, current duration is only 30 seconds, with current ramping up and down of 10 seconds each. Moreover, the electrostimulation device is automatically turned off without patient's perception. Thus, patients experience early sensations (mild to moderate tingling) in stimulation site without inducing effect. Moreover, after each tDCS session, patients will answer adverse effects questionnaire.</description>
    <arm_group_label>Anodal tDCS + physical exercise 1</arm_group_label>
    <arm_group_label>Anodal tDCS + physical exercise 2</arm_group_label>
    <arm_group_label>Cathodal tDCS + physical exercise 1</arm_group_label>
    <arm_group_label>Cathodal tDCS + physical exercise 2</arm_group_label>
    <arm_group_label>Sham tDCS + physical exercise 1</arm_group_label>
    <arm_group_label>Sham tDCS + physical exercise 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Rest</intervention_name>
    <description>15 or 30 minutes seat without move the legs</description>
    <arm_group_label>Rest/control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self reported healthy&#xD;
&#xD;
          -  Right handed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior neurological diseases&#xD;
&#xD;
          -  Multiple brain lesions&#xD;
&#xD;
          -  Metal implant in the skull and face&#xD;
&#xD;
          -  Pacemaker&#xD;
&#xD;
          -  History of seizures&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Hemodynamic instability&#xD;
&#xD;
          -  Use of medications which change the cortical excitability, such as antidepressants,&#xD;
             anxiolytics.&#xD;
&#xD;
          -  Energy expenditure &gt; 3000 METS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kátia Monte-Silva, PHD</last_name>
    <role>Study Director</role>
    <affiliation>Applied Neuroscience Laboratory, Universidade Federal de Pernambuco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Applied Neuroscience Laboratory, Universidade Federal de Pernambuco</name>
      <address>
        <city>Recife</city>
        <state>PE</state>
        <zip>50670-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>August 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>February 25, 2015</last_update_submitted>
  <last_update_submitted_qc>February 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Pernambuco</investigator_affiliation>
    <investigator_full_name>Kátia Monte-Silva</investigator_full_name>
    <investigator_title>PHD</investigator_title>
  </responsible_party>
  <keyword>Cortical excitability</keyword>
  <keyword>Plasticity</keyword>
  <keyword>Healthy subjects</keyword>
  <pending_results>
    <submitted>February 25, 2015</submitted>
    <returned>March 11, 2015</returned>
    <submitted>March 20, 2015</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>March 24, 2015</submitted>
    <returned>April 6, 2015</returned>
    <submitted>April 6, 2015</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>April 8, 2015</submitted>
    <returned>April 27, 2015</returned>
    <submitted>May 14, 2015</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>May 26, 2015</submitted>
    <returned>June 10, 2015</returned>
    <submitted>May 10, 2016</submitted>
    <returned>June 15, 2016</returned>
    <submitted>June 16, 2016</submitted>
    <returned>July 28, 2016</returned>
    <submitted>July 24, 2018</submitted>
    <submission_canceled>July 24, 2018</submission_canceled>
    <submitted>August 7, 2018</submitted>
    <returned>January 24, 2019</returned>
    <submitted>May 4, 2020</submitted>
    <returned>May 15, 2020</returned>
    <submitted>May 19, 2020</submitted>
    <returned>June 1, 2020</returned>
    <submitted>May 9, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02263092
org study id: Exercise_tdcs_metaplasticity
nct id: NCT02263092
lead sponsor: 
has dmc: Yes
This study aims to understand metaplasticity through the association of transcranial direct
      current stimulation (tDCS) and physical exercise. For this purpose, the study will be
      separate in 2 phases: in the first phase the aim is verify the effects of physical exercise
      on cortical excitability. After this 1st phase two intensities of physical exercise will be
      chosen for the second phase. In the 2nd phase, subjects will undergo to anodal, cathodal and
      sham tDCS plus physical exercise.
Before the two phases of the study, the subjects will be evaluate in the following aspects:
      anxiety by the beck anxiety inventory; depression by the beck depression inventory; level of
      physical exercise by the international physical activity questionnaire; stress by the stress
      perceived scale 10.

      In the first phase, the subjects will be undergo to 4 conditions: (i) 15 minutes of physical
      exercise with moderate intensity; (ii) 10 minutes of physical exercise with high intensity;
      (iii) 30 minutes of physical exercise with mild intensity; (iv) 15 or 30 minutes of rest.
      Before each condition, cortical excitability will be measure through the Transcranial
      magnetic stimulation by motor evoked potential (MEP); the blood glucose level will be
      evaluate by glucometer. The MEP also will be done immediately after the physical exercise and
      in every 5 min for 30 after the end of exercise/rest. The blood glucose level will be done
      immediately after the exercise..

      In the second phase, the subjects will be undergo to 6 conditions: (i) anodal tDCS + physical
      exercise 1; (ii) anodal tDCS + physical exercise 2; (iii) cathodal tDCS + physical exercise
      1; (iv) cathodal tDCS + physical exercise 2; (v) sham tDCS + physical exercise 1; (vi) sham
      tDCS + physical exercise 2. The intensity and time of physical exercise depends of the
      results of the previous phase and will be determine after the end of phase 1. In this phase,
      the blood glucose level will be evaluate before and immediately the physical exercise. The
      cortical excitability will be evaluate through the Transcranial magnetic stimulation by the
      following measures: motor evoked potential - before the tDCS,after tDCS, immediately , 10,
      20, 30, 60, 90 minutes after the exercise; resting motor threshold - before tdcs, immediately
      and 90 minutes after the exercise; recruitment curve - before tdcs, immediately and 90
      minutes after the exercise.

      tDCS condition During tDCS application, patients will be seated in a comfortable chair with
      head and arms rests. Current will be applied by a DC stimulator (NeuroConn, Germany) using a
      pair of saline-soaked sponge electrodes (surface 35 and 36cm²).

      tDCS will be applied to Cz and Oz according to International 10-20 EEG system. In the anodal
      tDCS, the anode will be placed in Cz and cathode in Oz. In the cathodal tDCS the inverse
      position will be done. Parameters of current intensity and duration (dose) used were
      previously established in poststroke patients: 2 mA stimulation intensity for 20 minutes with
      current ramping up and down of 10 seconds each.

      Sham tDCS has been used in several studies to evaluate the effect of active tDCS. For sham,
      the same position of anodal tDCS will be assumed, however, current duration is only 30
      seconds, with current ramping up and down of 10 seconds each. Moreover, the
      electrostimulation device is automatically turned off without patient's perception. Thus,
      patients experience early sensations (mild to moderate tingling) in stimulation site without
      inducing effect. Moreover, after each tDCS session, patients will answer adverse effects
      questionnaire.

      Physical exercise condition The intensity of physical exercise will be determine by the
      maximum heart rate (max HR) using the formula (220 - age). For the high intensity, the
      intensity will between xx and xx% of maxHR; moderate intensity, 64-76% of maxHR; mild
      intensity, 57-63% of maxHR. Furthermore, during the physical exercise the heart rate will be
      continuous evaluate by the POLAR and the rate perceived scale will be register in each 3
      minutes by the modified Borg scale Outcome measures Evaluation of brain activity will be
      performed using single-pulse transcranial magnetic stimulation (TMS-p). Magnetic stimulation
      (Neurosoft, Russia) will be applied through a figure-8 coil to determine motor cortex
      representation of right tibial anterior muscle (hotspot) and performed the following
      electrophysiological measures to assess cortical activity: (i) Motor Evoked Potential (MEP);
      (ii) resting motor threshold (RMT) and (iii) Recruitment curve (RC).

      Firstly, patients will be instructed to sit in a chair and to search a comfortable position.
      The hotspot will be considered the most excitable area, with more intense motor evoked
      potential (MEP), measured by electromyography.

      The following electrophysiological measures will be performed in left cerebral hemisphere to
      assess cortical activity:

      (i) Motor Evoked Potential (MEP) : the intensity of magnetic stimulator is adjusted to
      produce an average MEP of 0.4 mV. TMS-p will be applied in the area of cortical
      representation of the tibial anterior and mean responses to stimuli should reach 0.4 to 0.6
      mV.

      (ii) Resting motor threshold (RMT) : will be request to the patient to perform contraction of
      the tibial anterior muscle and then, will be given ten pulses by TMS-p to determinate resting
      motor threshold. Motor threshold corresponds to the lowest intensity of TMS-p to produce a
      MEP of 50μV in 50% of the pulses applied to the hotspot.

      (iii) Recruitment curve (RC): Five stimuli were applied at each of the following intensities:
      5% below resting motor threshold (RMT), RMT, 5% above RMT, 10% above RMT, 20% above RMT, 30%
      above RMT, 35% above RMT and at 100% of stimulator output. The five stimuli at each intensity
      were delivered in a block, but the order of stimulation intensity changes was random. The
      interval between successive TMS stimuli was between 5.5 to 6.5 s.
allocation: Randomized
intervention model: Crossover Assignment
masking: Double (Participant, Outcomes Assessor)
measure: Change on cortical excitability - motor evoked potential (MEP)
time frame: Phase 1 - in each session (every day), baseline and every 5 minutes for 30 minutes after exercise/rest. Phase 2 - in each session (every day), baseline, after, 10, 20, 30, 60 and 90 after tDCS + exercise
measure: Change on cortical excitability - resting motor threshold (RMT)
time frame: Phase 2 - in each session (every day), baseline, after and 90 after tDCS + exercise
measure: Change on cortical excitability - Recruitment curve (RC)
time frame: Phase 2 - in each session (every day), baseline, after and 90 after tDCS + exercise
arm group label: 15 minutes of physical exercise
arm group type: Experimental
description: the subjects will do physical exercise on a treadmill with 64 to 74% of maxHR
arm group label: 10 minutes of physical exercise
arm group type: Experimental
description: - the subjects will do physical exercise on a treadmill with 77 to 95% of maxHR.
arm group label: 30 minutes of physical exercise
arm group type: Experimental
description: - the subjects will do physical exercise on a treadmill with 57 to 63% of maxHR.
arm group label: Rest/control
arm group type: Experimental
description: the subjects will be on 15 or 30 minutes seat without move the legs.
arm group label: Anodal tDCS + physical exercise 1
arm group type: Experimental
description: the subjects will be undergo to anodal tDCS + physical exercise 1
arm group label: Anodal tDCS + physical exercise 2
arm group type: Experimental
description: the subjects will be undergo to anodal tDCS + physical exercise 2
arm group label: Cathodal tDCS + physical exercise 1
arm group type: Experimental
description: the subjects will be undergo to cathodal tDCS + physical exercise 1
arm group label: Cathodal tDCS + physical exercise 2
arm group type: Experimental
description: - the subjects will be undergo to cathodal tDCS + physical exercise 2
arm group label: Sham tDCS + physical exercise 1
arm group type: Experimental
description: the subjects will be undergo to sham tDCS + physical exercise 1
arm group label: Sham tDCS + physical exercise 2
arm group type: Experimental
description: the subjects will be undergo to sham tDCS + physical exercise 2
intervention type: Behavioral
intervention name: Physical exercise
description: The intensity of physical exercise will be determine by the maximum heart rate (max HR) using the formula (220 - age). For the high intensity, the intensity will between 79-95% xx% of maxHR; moderate intensity, 64-76% of maxHR; mild intensity, 57-63% of maxHR. Furthermore, during the physical exercise the heart rate will be continuous evaluate by the POLAR and the rate perceived scale will be register in each 3 minutes by the modified Borg scale
arm group label: 10 minutes of physical exercise
arm group label: 15 minutes of physical exercise
arm group label: 30 minutes of physical exercise
arm group label: Anodal tDCS + physical exercise 1
arm group label: Anodal tDCS + physical exercise 2
arm group label: Cathodal tDCS + physical exercise 1
arm group label: Cathodal tDCS + physical exercise 2
arm group label: Sham tDCS + physical exercise 1
arm group label: Sham tDCS + physical exercise 2
intervention type: Device
intervention name: tDCS
description: Current will be applied by a DC stimulator (NeuroConn, Germany) using a pair of saline-soaked sponge electrodes (surface 35 and 36cm²). tDCS will be applied to Cz and Oz according to International 10-20 EEG system. In the anodal tDCS, the anode will be placed in Cz and cathode in Oz. In the cathodal tDCS the inverse position will be done. Parameters of current intensity and duration (dose) used were 2 mA stimulation intensity for 20 minutes with current ramping up and down of 10 seconds each.For sham, the same position of anodal tDCS will be assumed, however, current duration is only 30 seconds, with current ramping up and down of 10 seconds each. Moreover, the electrostimulation device is automatically turned off without patient's perception. Thus, patients experience early sensations (mild to moderate tingling) in stimulation site without inducing effect. Moreover, after each tDCS session, patients will answer adverse effects questionnaire.
arm group label: Anodal tDCS + physical exercise 1
arm group label: Anodal tDCS + physical exercise 2
arm group label: Cathodal tDCS + physical exercise 1
arm group label: Cathodal tDCS + physical exercise 2
arm group label: Sham tDCS + physical exercise 1
arm group label: Sham tDCS + physical exercise 2
intervention type: Behavioral
intervention name: Rest
description: 15 or 30 minutes seat without move the legs
arm group label: Rest/control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kátia Monte-Silva, PHD
role: Study Director
affiliation: Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal de Pernambuco
investigator full name: Kátia Monte-Silva
investigator title: PHD
submitted: February 25, 2015
returned: March 11, 2015
submitted: March 20, 2015
submission canceled: Unknown
submitted: March 24, 2015
returned: April 6, 2015
submitted: April 6, 2015
submission canceled: Unknown
submitted: April 8, 2015
returned: April 27, 2015
submitted: May 14, 2015
submission canceled: Unknown
submitted: May 26, 2015
returned: June 10, 2015
submitted: May 10, 2016
returned: June 15, 2016
submitted: June 16, 2016
returned: July 28, 2016
submitted: July 24, 2018
submission canceled: July 24, 2018
submitted: August 7, 2018
returned: January 24, 2019
submitted: May 4, 2020
returned: May 15, 2020
submitted: May 19, 2020
returned: June 1, 2020
submitted: May 9, 2023