<?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>IRCT20220228054148N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-20</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the effectiveness of transcranial light therapy method on children with a math learning disorder</public_title>
      <acronym>transcranial Low-Level Light Therapy (LLLT)</acronym>
      <scientific_title>Evaluating the effectiveness of transcranial light therapy method on number sense, computation, visuospatial memory, phonological processing, academic progress, electrophysiological function, and brain map of children with a math learning disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66356</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: no, Blinding description: None of the participants will know whether they are in the intervention or control group. Participants in the intervention group will undergo transcranial light therapy through laser radiation. On the other hand, the participants in the control group will not receive any amount of laser by placing a metal filter on the place of laser radiation as an obstacle. More precisely, none of the participants will know whether they have been exposed to laser radiation or not.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Math learnin disability.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the transcranial light therapy intervention, light will be emitted by the Lumix 3 laser device, with a wavelength of 1064 nm, continuously, with a power density of 250 mW/cm2 and an energy density of 60 J/cm2. The source of light production in this projector will be light diodes. The desired wavelength will be irradiated bilaterally in the intraparietal sulcus (IPS) for 10 minutes. The number of transcranial light therapy sessions will be 1 session and the cumulative dose will be 600 mW/cm2. Intervention 2: Control group: The participants in the control group will not receive any amount of the energy density received by the experimental group by placing a metal filter on the laser radiation site.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas Ebrahimi Kalan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Neurosciences and Cognition,  Faculty of Advanced Medical Sciences,  Tabriz University of Medical Sciences,  Tabriz, Iran.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138837311</zip>
        <telephone>+98 41 3335 5788</telephone>
        <email>abbasebra@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Ali Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Neuroscience Iran University of Medical Sciences, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138837311</zip>
        <telephone>+98 41 3554 0447</telephone>
        <email>nazaripsycho@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a math learning disorder
Age range 8 to 13 years
Normal IQ</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>13 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of seizures, epilepsy or its family history
Taking medicine or special medicines affecting the nervous system
Presence of other neuropsychological diseases
Non-cooperation in sessions
Absence of more than two sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F81.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mathematics disorder</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 the transcranial light therapy intervention, light will be emitted by the Lumix 3 laser device, with a wavelength of 1064 nm, continuously, with a power density of 250 mW/cm2 and an energy density of 60 J/cm2. The source of light production in this projector will be light diodes. The desired wavelength will be irradiated bilaterally in the intraparietal sulcus (IPS) for 10 minutes. The number of transcranial light therapy sessions will be 1 session and the cumulative dose will be 600 mW/cm2.</i_keyword>
      <i_keyword>Control group: The participants in the control group will not receive any amount of the energy density received by the experimental group by placing a metal filter on the laser radiation site.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number sense. Timepoint: Before and after the intervention. Method of measurement: Numerical Stroop test.</prim_outcome>
      <prim_outcome>Computation. Timepoint: Before and after the intervention. Method of measurement: Single or multi-digit calculations (addition, subtraction, multiplication, and division).</prim_outcome>
      <prim_outcome>Visual-spatial memory. Timepoint: Before and after the intervention. Method of measurement: Corsi Block.</prim_outcome>
      <prim_outcome>Phonological processing. Timepoint: Before and after the intervention. Method of measurement: Wechsler intelligence test supplementary scale 5 (naming speed).</prim_outcome>
      <prim_outcome>Achievement. Timepoint: Before and after the intervention. Method of measurement: Educational reports of the child.</prim_outcome>
      <prim_outcome>Electrophysiological function. Timepoint: Before and after the intervention. Method of measurement: Event-related potentials (ERPs).</prim_outcome>
      <prim_outcome>Brain map. Timepoint: Before and after the intervention. Method of measurement: Quantitative electroencephalography.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-06</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>No. 97, 12m Laklar Alley, Jonubi Shariati Street, Tabriz, East Azerbaijan Province, Iran. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
