<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/NCT04467476</url>
  </required_header>
  <id_info>
    <org_study_id>tDCS and anaerobic power</org_study_id>
    <nct_id>NCT04467476</nct_id>
  </id_info>
  <brief_title>Effects of tDCS on Anaerobic Power of Lower Limb Muscles</brief_title>
  <official_title>Effects of tDCS on Mechanical Power of the Leg Extensor Muscles of Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Piauí</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Piauí</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>
      Anaerobic power and capacity are essential in many human activities, especially during sports&#xD;
      practice that demand a high strength and power of the limbs. Transcranial direct current&#xD;
      stimulation is a noninvasive technique that can modulate motor brain areas involved in motor&#xD;
      functions and has the potential to optimize muscle capacity. However, their effects on&#xD;
      mechanical power are lacking.&#xD;
&#xD;
      This study aims to investigate the effects of transcranial direct current stimulation (tDCS)&#xD;
      on mechanical power in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, a randomized, crossover, double-blind, placebo-controlled experimental design&#xD;
      will be used. The 50 participants will be randomized into two groups: (1) Anodal tDCS(real)&#xD;
      and (2) Sham tDCS. A single session of anodal and sham tDCS will be performed on each task&#xD;
      (pre and post-jump test).&#xD;
&#xD;
      All evaluations will be performed by a single researcher who, like the participants, will not&#xD;
      know which stimulation group will be participating. Subjects who agree to the conditions and&#xD;
      sign the consent form may participate in the study. Participants who meet the eligibility&#xD;
      criteria will be included in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Actual">April 29, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean anaerobic power</measure>
    <time_frame>Pre and Post-test (immediately after tDCS)</time_frame>
    <description>Mean anaerobic power will be evaluated by assessing the ground reaction forces (GRF) and the number of jumps in each test by means of the kinetic analysis of the 60-second vertical jump test (Bosco's Test).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peak anaerobic power</measure>
    <time_frame>Pre and Post-test (immediately after tDCS)</time_frame>
    <description>Peak anaerobic power will be evaluated by assessing the ground reaction forces (GRF) and the number of jumps in each test by means of the kinetic analysis of the 60-second vertical jump test (Bosco's Test).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue index</measure>
    <time_frame>Pre and Post-test (immediately after tDCS)</time_frame>
    <description>Fatigue index will be evaluated by assessing the ground reaction forces (GRF) and the number of jumps in each test by means of the kinetic analysis of the 60-second vertical jump test (Bosco's Test).&#xD;
The fatigue index corresponds to the power reduction rate expressed as a percentage and reveals the degree of reduction in the ability to produce strength and maintain exercise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rating of perceived exertion</measure>
    <time_frame>Post-test (immediately after tDCS)</time_frame>
    <description>The subjective feeling of effort will be assessed by the Borg scale for perceived effort. This is a 15-point numerical scale that ranges from 6 to 20, where 6 means &quot;no exertion at all&quot; and 20 means &quot;maximal exertion.&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>tDCS (anodal)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>tDCS: 20 minutes, 2mA, over the motor cortex representation of lower limbs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tDCS (sham)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>tDCS: 20 minutes (but 30s ON), 2mA, over the motor cortex representation of lower limbs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial direct current stimulation</intervention_name>
    <description>Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various health conditions. However, its ergogenic effect still has controversial results.</description>
    <arm_group_label>tDCS (anodal)</arm_group_label>
    <arm_group_label>tDCS (sham)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects with no complaints of pain or any kind of discomfort in the&#xD;
             musculoskeletal system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Musculoskeletal or neurological disorder&#xD;
&#xD;
          -  Under medication&#xD;
&#xD;
          -  Previous treatment with tDCS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fuas A Hazime, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Physical Therapy. Federal University of Piaui</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Physical Therapy. Federal University of Piaui</name>
      <address>
        <city>Parnaíba</city>
        <state>Piauí</state>
        <zip>64202020</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Piauí</investigator_affiliation>
    <investigator_full_name>Fuad Ahmad Hazime</investigator_full_name>
    <investigator_title>Clinical Professor - Physical Therapy Department</investigator_title>
  </responsible_party>
  <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/NCT04467476
org study id: tDCS and anaerobic power
nct id: NCT04467476
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Anaerobic power and capacity are essential in many human activities, especially during sports
      practice that demand a high strength and power of the limbs. Transcranial direct current
      stimulation is a noninvasive technique that can modulate motor brain areas involved in motor
      functions and has the potential to optimize muscle capacity. However, their effects on
      mechanical power are lacking.

      This study aims to investigate the effects of transcranial direct current stimulation (tDCS)
      on mechanical power in healthy subjects.
In this study, a randomized, crossover, double-blind, placebo-controlled experimental design
      will be used. The 50 participants will be randomized into two groups: (1) Anodal tDCS(real)
      and (2) Sham tDCS. A single session of anodal and sham tDCS will be performed on each task
      (pre and post-jump test).

      All evaluations will be performed by a single researcher who, like the participants, will not
      know which stimulation group will be participating. Subjects who agree to the conditions and
      sign the consent form may participate in the study. Participants who meet the eligibility
      criteria will be included in the study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Mean anaerobic power
time frame: Pre and Post-test (immediately after tDCS)
description: Mean anaerobic power will be evaluated by assessing the ground reaction forces (GRF) and the number of jumps in each test by means of the kinetic analysis of the 60-second vertical jump test (Bosco's Test).
measure: Peak anaerobic power
time frame: Pre and Post-test (immediately after tDCS)
description: Peak anaerobic power will be evaluated by assessing the ground reaction forces (GRF) and the number of jumps in each test by means of the kinetic analysis of the 60-second vertical jump test (Bosco's Test).
measure: Fatigue index
time frame: Pre and Post-test (immediately after tDCS)
description: Fatigue index will be evaluated by assessing the ground reaction forces (GRF) and the number of jumps in each test by means of the kinetic analysis of the 60-second vertical jump test (Bosco's Test).
The fatigue index corresponds to the power reduction rate expressed as a percentage and reveals the degree of reduction in the ability to produce strength and maintain exercise.
measure: Rating of perceived exertion
time frame: Post-test (immediately after tDCS)
description: The subjective feeling of effort will be assessed by the Borg scale for perceived effort. This is a 15-point numerical scale that ranges from 6 to 20, where 6 means "no exertion at all" and 20 means "maximal exertion."
arm group label: tDCS (anodal)
arm group type: Active Comparator
description: tDCS: 20 minutes, 2mA, over the motor cortex representation of lower limbs.
arm group label: tDCS (sham)
arm group type: Sham Comparator
description: tDCS: 20 minutes (but 30s ON), 2mA, over the motor cortex representation of lower limbs.
intervention type: Device
intervention name: Transcranial direct current stimulation
description: Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various health conditions. However, its ergogenic effect still has controversial results.
arm group label: tDCS (anodal)
arm group label: tDCS (sham)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fuas A Hazime, PhD
role: Principal Investigator
affiliation: Department of Physical Therapy. Federal University of Piaui
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Piauí
investigator full name: Fuad Ahmad Hazime
investigator title: Clinical Professor - Physical Therapy Department
sharing ipd: Undecided