<?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>IRCT20230729058958N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-03</date_registration>
      <primary_sponsor>Razi University</primary_sponsor>
      <public_title>Single-Site and Dual-Site Transcranial Direct Current Stimulation and Endurance Exercise</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effects of Single-Site and Dual-Site Transcranial Direct Current Stimulation on Exercise Performance and Psychophysiological Responses of Trained Men in an Endurance Exercise</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71680</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Randomization description: In this study, in order to randomize the order of subject exposure to four different conditions (4 different types of electrical stimulation of the brain), the Latin square method will be used.  For this purpose, first, using the website www.random.org, each subject will be randomly assigned a number between 1 and 12 as an identification code.  Then, the English letters D, C, B, A are assigned to four intervention conditions and a Latin square will be created with four rows and four columns.  After creating the Latin square, participants number 1 to 3 in the sequence of the first row, participants 4 to 6 in the sequence of the second row, participants 7 to 9 in the sequence of the third row and participants 10 to 12 in the sequence of the fourth row  will be placed, Blinding description: In this double-blind study, the researcher and participants will be blinded to the type of transcranial electrical stimulation used and the location of stimulation in each session.  In the present study, the Neurostim stimulation device was used to induce direct current electrical stimulation in four separate sessions and four different modes including: 1) anodal stimulation of the primary motor cortex, 2) anodal stimulation of the posterior-lateral prefrontal cortex, 3) anodal stimulation of the two  regional, 4) sham stimulation (placebo) will be used.  For this purpose, a person outside the research team will be responsible for applying electrical stimulation in four experimental sessions.  In order to blind the participants, after they sit on a special chair, the electrical stimulation device of the brain is hidden from their sight and covered by a cover completely, and the electrodes will be placed on the desired areas by the examiner.  In order to blind the researcher, before the intervention, the researcher leaves the laboratory and returns to the test site after the stimulation period has passed and the electrodes are removed and the stimulation device is turned off.  Also, in the sham stimulation mode, according to standard protocols, the active current is induced on the head for 30 seconds to induce the same sensation as the active stimulation mode, and then the current is cut off and the stimulation is deactivated.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The participants are healthy people..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, all the subjects were exposed to all three intervention conditions with an interval of one week, including: 1) anodal stimulation of the primary motor cortex, 2) anodal stimulation of the posterior-lateral prefrontal cortex, 3) bilateral cerebral anodal stimulation.  will get  In all three conditions, the duration of stimulation will be 20 minutes with an intensity of 2 mA.  In order to stimulate, the Neurostim stimulation device manufactured by Medina Teb Company will be used.  The target areas in the brain are identified using the 10-20 international brain mapping system, and the target areas are stimulated using special stimulation electrodes and a special electroencephalogram cap. Intervention 2: Control group: In this study, in addition to three intervention sessions, all subjects will be exposed to one control session including brain electrical stimulation in sham (placebo) mode.  All the details of the implementation of the protocol in the control mode will be similar to the intervention mode, with the difference that in the control mode, the electrical stimulation of the brain is not done and the electrical current of the stimulating device will be deactivated after 30 seconds.  The duration of the control condition will 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 can be shared after de-identifying subjects.

When:
6 months after printing the results

To whom:
Researchers

Conditions:
For meta-analytic research

Where to obtain:
If you need to receive documents, send an email to Hasna Khoshchehre, research researcher, with the email address: h.khoshchehre98@gmail.com.

How to obtain:
In case of an official request, stating the relevant reasons and mentioning the complete details, the data will be sent via email after 72 hours.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ehsan Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Kermanshah, Taqbestan, University St., Razi University, Faculty of Sports Sciences</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3845 8428</telephone>
        <email>e.amiri@gmail.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ehsan Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Kermanshah, Taqbestan, University St., Razi University, Faculty of Sports Sciences</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>Endurance trained men with a history of at least one year of regular training.
Body mass index (BMI) 18.5 to 24.9 kg per square meter of height.
obtaining a certificate of non-prohibition of participating in sports training programs from a doctor.
Not suffering from color blindness or color vision disorders.
The age range is 18 to 35 years.
being right-handed.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having any cardiovascular, pulmonary and metabolic disease.
History of seizures, epilepsy or other types of neurological diseases.
The presence of implantable devices or pacemakers in the body.
Smoking and alcohol consumption.</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 the subjects were exposed to all three intervention conditions with an interval of one week, including: 1) anodal stimulation of the primary motor cortex, 2) anodal stimulation of the posterior-lateral prefrontal cortex, 3) bilateral cerebral anodal stimulation.  will get  In all three conditions, the duration of stimulation will be 20 minutes with an intensity of 2 mA.  In order to stimulate, the Neurostim stimulation device manufactured by Medina Teb Company will be used.  The target areas in the brain are identified using the 10-20 international brain mapping system, and the target areas are stimulated using special stimulation electrodes and a special electroencephalogram cap.</i_keyword>
      <i_keyword>Control group: In this study, in addition to three intervention sessions, all subjects will be exposed to one control session including brain electrical stimulation in sham (placebo) mode.  All the details of the implementation of the protocol in the control mode will be similar to the intervention mode, with the difference that in the control mode, the electrical stimulation of the brain is not done and the electrical current of the stimulating device will be deactivated after 30 seconds.  The duration of the control condition will be 20 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time gained in time trial endurance performance. Timepoint: After finishing the time trial endurance activity. Method of measurement: Record the time and distance using a bicycle car meter.</prim_outcome>
      <prim_outcome>Amplitude of muscle electromyography. Timepoint: Every three kilometers and for 30 seconds. Method of measurement: 8-channel wireless electromyography device (model 85260 Noraxon, Scottsdale, AZ).</prim_outcome>
      <prim_outcome>The degree of perception of pressure. Timepoint: Once every three kilometers. Method of measurement: Using a pressure perception scale of 0 to 100 borg.</prim_outcome>
      <prim_outcome>Cognitive function. Timepoint: Before and after endurance activity. Method of measurement: Using color-word Stroop test.</prim_outcome>
      <prim_outcome>Countdown cognitive test to measure hypofrontality. Timepoint: During the performance of endurance activity in kilometers 4, 8 and 12. Method of measurement: A number from 200 to 300 will be randomly announced by the examinee out loud and the subject will be asked to count out loud for 1 minute in reverse and with a distance of 3 from the announced number.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Selective reaction time. Timepoint: Before and after endurance activity. Method of measurement: Using selective reaction time device.</sec_outcome>
      <sec_outcome>Pleasure scale. Timepoint: Once every three kilometers. Method of measurement: Using an 11-item emotion scale.</sec_outcome>
      <sec_outcome>Arousal scale. Timepoint: Once every three kilometers. Method of measurement: Using a 6-item scale of perceived arousal.</sec_outcome>
      <sec_outcome>Pain scale. Timepoint: Once every three kilometers. Method of measurement: Using a visual analog scale of 0 to 10.</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>2023-05-10</approval_date>
        <contact_name>Razi University Research Ethics Committee</contact_name>
        <contact_address>Iran, Kermanshah, Taq Bostan, University St., Razi University Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
