<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20210617051606N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-04</date_registration>
      <primary_sponsor>Razi University</primary_sponsor>
      <public_title>Non-invasive brain stimulation and anaerobic performance</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Transcranial Direct Current Stimulation on Athletic and Cognitive Performance During and After Maximal Anaerobic Task</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61585</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Randomization description: In this study, the order of subjects' exposure to 3 different conditions (3 different types of electrical stimulation of the brain) will be randomized by the Latin Squares method. To do so, first using the site www.random.org, a number between 1 and 15 will be randomly allocated to each subject as an identification code. Then, the English letters A, B, and C will be assigned to the three intervention conditions and a Latin Square will be created. In this case, a Latin square with three rows and three columns is created. Finally, participants 1 to 5 will be placed in the sequence of the first row, participants 6 to 10 will be placed in the sequence of the second row, and participants 11 to 15 will be placed in the sequence of the third row, Blinding description: In this double-blind study, the investigator and participants will be blinded to the type and target areas of transcranial electrical stimulation used in each session. In the present study, a Neurostim stimulator will be used to induce direct current electrical stimulation in three separate sessions and in three different modes, including 1) Anodal stimulation of the primary motor cortex (M1), 2) Anodal stimulation of the dorsolateral prefrontal cortex (DLPFC), 3) sham stimulation (Placebo effect). To do so, an individual outside the research team will be responsible for applying electrical stimulation in three test sessions. In order to blind the participants, after they sit on a special chair, the stimulator will be hidden from their view and wrapped by a cover, and the electrodes will be placed on the target areas by that individual. In order to blind the investigator, before the intervention, the investigator leaves the laboratory and returns to the test site after the termination of the stimulation time, removal of the electrodes, and turning off the stimulator. Also, in Sham stimulation mode, according to standard protocols, active current will be applied for 30 seconds in order to induce a feeling similar to active stimulation modes, and then the current is cut off and the stimulation will be deactivated.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The participants are healthy individuals.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, all subjects will be exposed to two intervention conditions with an interval of at least 72 hours, including 1) anodal electrical brain stimulation of the primary motor cortex, 2) anodal electrical brain stimulation of the dorsolateral prefrontal cortex. In both conditions, the stimulation duration will be 20 minutes and its intensity will be 2 milliamperes. A Neurostim stimulator device made by Medina Teb Company will be used for brain stimulation. Target areas in the brain are identified using the International Brain Mapping 10-20 System. The stimulation of target areas is performed using two special electrodes and a special electroencephalogram (EEG) cap. Under intervention conditions, first, the study variables will be measured and then the subjects will receive brain stimulation. Subjects will then perform 3 bouts of the 30-second Wingate test of the lower limb with 4-minute resting intervals between each bout, and finally, the variables will be re-measured. Intervention 2: Control group: In this study, in addition to two intervention sessions, all subjects were exposed to a control session including sham electrical brain stimulation (placebo effect). All details of the control session will be similar to the intervention sessions, except that in the control session, the brain is not electrically stimulated and the electrical current of the stimulator device will be deactivated after 30 seconds. The duration of control conditions will also be 20 minutes.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data are shared after the de-identification of the participants

When:
3 months after publication

To whom:
All individuals upon formal request

Conditions:
Data sharing requests are accepted for any purposes

Where to obtain:
To obtain any data/document, please send an e-mail to Ehsan Amiri, a faculty member at Razi University, through the following e-mail address: e.amiri@razi.ac.ir

How to obtain:
Upon formal request, mentioning due reasons, and providing full personality details, data will be sent after 72 h via e-mail

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ehsan Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 73, Faculty of Sport Sciences, Razi University, Tagh-e-Bostan, University St., Kermanshah, Iran</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3845 8428</telephone>
        <email>e.amiri@razi.ac.ir</email>
        <affiliation>Razi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ehsan Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 73, Faculty of Sport Sciences, Razi University, Tagh-e-Bostan, University St., Kermanshah, Iran</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3845 8428</telephone>
        <email>e.amiri@razi.ac.ir</email>
        <affiliation>Razi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged between 18 to 30 years old
Student of physical education and sport sciences, third semester or higher
Reside in Kermanshah city
Being familiar and having experience in performing anaerobic training
Getting the certification of no prohibition of participating in the exercise training program from a specialist</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Suffering from any cardiovascular, pulmonary and metabolic diseases
History of seizures, epilepsy, or other neurological diseases
Existence of implantable devices or pacemakers in the body
Tobacco and alcohol consumption
Refusal to give informed consent</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, all subjects will be exposed to two intervention conditions with an interval of at least 72 hours, including 1) anodal electrical brain stimulation of the primary motor cortex, 2) anodal electrical brain stimulation of the dorsolateral prefrontal cortex. In both conditions, the stimulation duration will be 20 minutes and its intensity will be 2 milliamperes. A Neurostim stimulator device made by Medina Teb Company will be used for brain stimulation. Target areas in the brain are identified using the International Brain Mapping 10-20 System. The stimulation of target areas is performed using two special electrodes and a special electroencephalogram (EEG) cap. Under intervention conditions, first, the study variables will be measured and then the subjects will receive brain stimulation. Subjects will then perform 3 bouts of the 30-second Wingate test of the lower limb with 4-minute resting intervals between each bout, and finally, the variables will be re-measured.</i_keyword>
      <i_keyword>Control group: In this study, in addition to two intervention sessions, all subjects were exposed to a control session including sham electrical brain stimulation (placebo effect). All details of the control session will be similar to the intervention sessions, except that in the control session, the brain is not electrically stimulated and the electrical current of the stimulator device will be deactivated after 30 seconds. The duration of control conditions will also be 20 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Change in anaerobic performance. Timepoint: During and after each bout of 30-seconds Wingate test. Method of measurement: By use of standard 30-seconds Wingate test of lower limb.</prim_outcome>
      <prim_outcome>Amplitude of muscle electromyography. Timepoint: During and after each bout of 30-seconds Wingate test of lower limb. Method of measurement: Sixteen channels wireless electromyography device (Noraxon, Scottsdale, AZ85260).</prim_outcome>
      <prim_outcome>Rating of Perceived Exertion. Timepoint: After each bout of 30-seconds Wingate test of lower limb. Method of measurement: By use of 6 to 20 perceived exertion Borg scale.</prim_outcome>
      <prim_outcome>Cognitive function. Timepoint: Before and after 3 bouts of 30-seconds Wingate test of lower limb. Method of measurement: by the use of Stroop Color-Word Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Choice reaction time. Timepoint: Before and after 3 bouts of 30-second Wingate test of lower limb. Method of measurement: By the use of Response Panel (63035A, Lafayette, Indiana) reaction time device.</sec_outcome>
      <sec_outcome>Pleasure sensation. Timepoint: After each bout of 30-second Wingate test of lower limb. Method of measurement: By the use of 11-item Feel Scale.</sec_outcome>
      <sec_outcome>The degree of arousal. Timepoint: After each bout of 30-second Wingate test of lower limb. Method of measurement: By the use of 6-item Felt Arousal Scale.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Razi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-29</approval_date>
        <contact_name>Research Ethics Committees of Kermanshah Razi University</contact_name>
        <contact_address>Room. 73, Faculty of Sport Sciences, Razi University, University Str, Taq-e-bostan, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
