<?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>IRCT20211116053071N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-21</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>effectiveness of tDCS on attention to eyes  in children with autism spectrum</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of transcranial direct current stimulation on attention to eyes compared with other facial features in children with autism spectrum by eye-tracker</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60008</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using simple randomization, each new person who enters the study uses the table of random numbers if the odd number is entered into the control group and if the even number is entered into the test group, and this is done until both groups are completed. continues . And except for the main researcher, persons will not know which group of study they have entered, Blinding description: Participants are evaluated by a eye tracker, it should be noted that they are evaluated by a person familiar with the eye tracker and uninformed to research. but tDCS is placed on the skull in the same way in both the experimental group and the control group, but in the control group, tDCS is turned on as a sham, which is turned off after the device is turned on after the initial burning sensation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>autism spectrum disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Using direct electrical stimulation by a tDCS-aware tester for 5 sessions for 20 minutes and five sessions per week, the anode electrode will be placed on the left DLPF and the cathode on the right shoulder through pads impregnated with physiological serum (1% NaCl) And will receive a current of 2 mA. The electrodes are placed according to the 10-20 system. Intervention 2: Control group:  Using direct electrical stimulation by a tDCS-aware tester for 5 sessions for 20 minutes and five sessions per week, the anode electrode will be placed on the left DLPF and the cathode on the right shoulder through pads impregnated with physiological serum (1% NaCl) And will receive a current of 2 mA. The electrodes are placed according to the 10-20 system  but the device turns on like a sham and turns off after a minute.</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:
The data will be published in such a way that the names of the people are not known and the people or data will be mentioned by the code

When:
after publish article

To whom:
researcher in univercity

Conditions:
for new research or meta analysis

Where to obtain:
dr Ashkan Irani
emai: ashkan2579@yahoo.com

How to obtain:
After submitting the application and sending the proposal, it will be made available to the applicant by presenting it in the council of the Physical Medicine Research Center, after agreeing and fulfilling the necessary obligations to preserve and use the information only for the agreed research.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ashkan Irani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>shariaty, tajrish</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1989934148</zip>
        <telephone>+98 21 2272 4209</telephone>
        <email>Ashkan2579@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>masood raigani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>shariaty, tajrish</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1989934148</zip>
        <telephone>+98 21 2272 4209</telephone>
        <email>ashkan2579@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of high-functioning autism by a pediatric psychiatrist based on criteria DSM-V and confirmation of diagnosis using interview Kiddie-SADS
Mild disorder according to the Autism spectrum Disorders Screening Questionnaire (ASSQ)
Age range 15 -7 years
Having normal or corrected visual acuity with glasses (with the approval of an optometrist)
Lack of physical and neurological disease
Discontinue the drug 72 hours before the intervention under the supervision of a physician
Absence of metal implants in vivo</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from neurological and neuropsychological diseases during the study
At any stage of the study that the subject was not willing to continue to cooperate, can be excluded from the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F84.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Autistic disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Using direct electrical stimulation by a tDCS-aware tester for 5 sessions for 20 minutes and five sessions per week, the anode electrode will be placed on the left DLPF and the cathode on the right shoulder through pads impregnated with physiological serum (1% NaCl) And will receive a current of 2 mA. The electrodes are placed according to the 10-20 system</i_keyword>
      <i_keyword>Control group:  Using direct electrical stimulation by a tDCS-aware tester for 5 sessions for 20 minutes and five sessions per week, the anode electrode will be placed on the left DLPF and the cathode on the right shoulder through pads impregnated with physiological serum (1% NaCl) And will receive a current of 2 mA. The electrodes are placed according to the 10-20 system  but the device turns on like a sham and turns off after a minute</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1- Total number eye fixation done. Timepoint: The first session before interval and the after fifth session with an interval of five days. Method of measurement: by Eye Tracker.</prim_outcome>
      <prim_outcome>Number of first fixation done. Timepoint: The first session before interval and the after fifth session with an interval of five days. Method of measurement: by Eye Tracker.</prim_outcome>
      <prim_outcome>Duration time of the first fixation. Timepoint: The first session before interval and the after fifth session with an interval of five days. Method of measurement: by Eye Tracker.</prim_outcome>
      <prim_outcome>Duration time of the first fixation to eye. Timepoint: The first session before interval and the after fifth session with an interval of five days. Method of measurement: by Eye Tracker.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-31</approval_date>
        <contact_name>vice-chancellor in Research Affair-Shhid Beheshti University of MedicalSciences</contact_name>
        <contact_address>shariaty street , tajrish squarer, shohadai Tajrish hospital tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
