<?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>IRCT20220406054427N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-12</date_registration>
      <primary_sponsor>Refah University College</primary_sponsor>
      <public_title>Effect of Brain stmulation in Math Problem Solving</public_title>
      <acronym></acronym>
      <scientific_title>The effect of combined neurofeedback therapy and transcranial electrical stimulation on the development of cognitive abilities and problem solving of high school students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>5</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62767</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Weakness in math problem-solving.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1: Students with poor math problem solving are referred to Irana Psychology and Counseling Clinic from two schools in Karaj with the consent of their parents. The study process was presented in full in the design. Five ninth grade male students, with the consent of their parents, participate in this study purposefully and voluntarily. Inclusion criteria between the ages of 14 and 16, weakness in solving mathematical problems, mathematical score of transcripts between 12 to 13.5, lack of clinical diagnosis in the field of learning disabilities and cognitive activities by a clinical specialist, absence from math reinforcement classes are also criteria for entry and absence More than one session of treatment sessions and attending out-of-school remedial classes will be the exclusion criteria. Then the fourth edition Wechsler test, which is for 10 to 18 year olds. Taken. In this study, 4 cognitive scales of Wechsler test (verbal comprehension, perceptual reasoning, working memory, processing speed) are considered and scores such as verbal and practical intelligence are not considered because the study is not in the field of intelligence assessment. Rather, only cognitive abilities are considered. Because the Wechsler test is factor analyzed, the use of subscales does not reduce validity. The math score of the previous semester is also calculated. The whole study will be conducted on 5 participants. Interventions will be performed individually for each of the 5 participants as a single control group. Independent variables will be extracranial electrical stimulation therapy with simultaneous solution of mathematical and neurofeedback problems. Dependent variables are also cognitive abilities (verbal comprehension, perceptual reasoning, working memory, processing speed) and mathematical problem solving. In intervention 1, participants will be exposed to transcranial direct current stimulation twice a week for 8 sessions, each session lasting 15 minutes. Electric excitation with direct transcranial current is performed through two extracorporeal excitation devices made by Medina Teb Iran Company. The method of excitation is that first the anode electrodes are placed by wet pads on the points P3, P4 of the parietal part. And the left shoulder and right shoulder cathode electrodes are cross-sectioned to direct current. The current from the first to the eighth session is as follows: the first session 1 mA, the second session 1.2 mA, the second session 1.4 mA, the third session 1.6 mA, the fourth session 1.8 mA and from the fifth session to the eighth session 2 Will be milliamperes. The aim of this stimulation is to increase the amplitude of alpha and theta relaxation and reduce the wave of beta 3 stress at the right and left points of the nostril. Because according to previous theories and research, increasing relaxation in the left parietal increases cognitive ability in mathematical details and increasing relaxation in the right parietal leads to understanding mathematical generalities. This stimulation increases blood flow to these areas and does not cause any harm or danger to the brain, and its safety has been proven time and time again in internal and external studies. Intervention 2: Intervention 2: Intervention 2 will be performed simultaneously with Intervention 1. In such a way that in the 15 minutes that each participant in each session of extracranial electrical stimulation to activate the brain in the right and left parietal points, he must simultaneously bring and do math exercises related to his class lesson and do at the same time. It does not matter if you do the exercise correctly or incorrectly. Rather, we know from theory that transcranial stimulation prepares neurons for action potential but does not create action potential. Therefore, there must be training or performing a skill that stimulates the brain and is ready to act, this time with great strength and power to create action potential. Therefore, they pursue such intentions. Participants in each session performed math homework with electrical stimulation. Intervention 3: Intervention 3: In intervention 3, just after the end of 15 minutes of transcranial electrical stimulation, the electrodes of the electrical stimulation device are separated and the neurofeedback electrodes are connected to the suture points P3, P4. The neurofeedback device will be dual channel Procomb 2 from Canada. Therefore, the source and reference electrodes will be placed on both P3, P4 and ground electrodes on the ear. In neurofeedback therapy, the participant is placed in front of a lip screen and a cartoon is played to him or her as desired. But the difference between this broadcast and the normal broadcast is that the performance and distribution of the cartoon depends on the model of concentration, breathing, and attention of the participant. The participant must, through trial and error and through the feedback given to him by the system, by keeping his concentration, breathing and eye movements, keep the alpha and theta levels in the parietal section in a position where the cartoon is broadcast. Otherwise the image will stop. Carba neurofeedback is done every 35 minutes after stimulation and its purpose is to stabilize the action potential created after the math exercises. At the end of intervention 3 in each session, the baseline is taken again from the participants to examine the changes in alpha, theta and beta 3 in each session. At the end of the eighth session, the participants are taken again from the Wechsler test, and their new math scores will be compared with the math score before the intervention, which will be reported to the researcher by the school. Data will be analyzed by Cohen's recovery percentage and effect size tables and visual analysis.</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 will be provided to the relevant organizations in compliance with ethical standards and there is no conflict in this regard.

When:
Six months after the results were published

To whom:
The data will be available to researchers, academics and clinical therapists.

Conditions:
Researchers who want to assess the intelligence and cognitive abilities of students with a disability in mathematics will be able to have and check the questionnaires.

Where to obtain:
Correspond to Zandkarimi@refah.ac.ir.

How to obtain:
Confirmation of the applicant as an academic, researcher or clinical therapist and confirmation of the purpose of the information request will be provided.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Fazlali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baharestan - Mardon street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1469684441</zip>
        <telephone>+98 21 3507 4315</telephone>
        <email>fatemeh.fazlali99@gmail.com</email>
        <affiliation>Refah University College</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ghazal Zandkarimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baharestan- Mardom Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1469684441</zip>
        <telephone>+98 21 3507 4315</telephone>
        <email>zandkarimi@refah.ac.ir</email>
        <affiliation>Refah University College</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Students weakness in math problem-solving  whose math score in the following transcript is between 12 and 13.5. ,
Lack of clinical diagnosis in the field of learning disability
Normal diagnosis in the field of cognitive activities by a clinician
Absence from math reinforcement classes</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>16 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Absence of more than one session of treatment sessions
Attendance at out-of-school remedial classes</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>Rehabilitation</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1: Students with poor math problem solving are referred to Irana Psychology and Counseling Clinic from two schools in Karaj with the consent of their parents. The study process was presented in full in the design. Five ninth grade male students, with the consent of their parents, participate in this study purposefully and voluntarily. Inclusion criteria between the ages of 14 and 16, weakness in solving mathematical problems, mathematical score of transcripts between 12 to 13.5, lack of clinical diagnosis in the field of learning disabilities and cognitive activities by a clinical specialist, absence from math reinforcement classes are also criteria for entry and absence More than one session of treatment sessions and attending out-of-school remedial classes will be the exclusion criteria. Then the fourth edition Wechsler test, which is for 10 to 18 year olds. Taken. In this study, 4 cognitive scales of Wechsler test (verbal comprehension, perceptual reasoning, working memory, processing speed) are considered and scores such as verbal and practical intelligence are not considered because the study is not in the field of intelligence assessment. Rather, only cognitive abilities are considered. Because the Wechsler test is factor analyzed, the use of subscales does not reduce validity. The math score of the previous semester is also calculated. The whole study will be conducted on 5 participants. Interventions will be performed individually for each of the 5 participants as a single control group. Independent variables will be extracranial electrical stimulation therapy with simultaneous solution of mathematical and neurofeedback problems. Dependent variables are also cognitive abilities (verbal comprehension, perceptual reasoning, working memory, processing speed) and mathematical problem solving. In intervention 1, participants will be exposed to transcranial direct current stimulation twice a week for 8 sessions, each session lasting 15 minutes. Electric excitation with direct transcranial current is performed through two extracorporeal excitation devices made by Medina Teb Iran Company. The method of excitation is that first the anode electrodes are placed by wet pads on the points P3, P4 of the parietal part. And the left shoulder and right shoulder cathode electrodes are cross-sectioned to direct current. The current from the first to the eighth session is as follows: the first session 1 mA, the second session 1.2 mA, the second session 1.4 mA, the third session 1.6 mA, the fourth session 1.8 mA and from the fifth session to the eighth session 2 Will be milliamperes. The aim of this stimulation is to increase the amplitude of alpha and theta relaxation and reduce the wave of beta 3 stress at the right and left points of the nostril. Because according to previous theories and research, increasing relaxation in the left parietal increases cognitive ability in mathematical details and increasing relaxation in the right parietal leads to understanding mathematical generalities. This stimulation increases blood flow to these areas and does not cause any harm or danger to the brain, and its safety has been proven time and time again in internal and external studies.</i_keyword>
      <i_keyword>Intervention 2: Intervention 2 will be performed simultaneously with Intervention 1. In such a way that in the 15 minutes that each participant in each session of extracranial electrical stimulation to activate the brain in the right and left parietal points, he must simultaneously bring and do math exercises related to his class lesson and do at the same time. It does not matter if you do the exercise correctly or incorrectly. Rather, we know from theory that transcranial stimulation prepares neurons for action potential but does not create action potential. Therefore, there must be training or performing a skill that stimulates the brain and is ready to act, this time with great strength and power to create action potential. Therefore, they pursue such intentions. Participants in each session performed math homework with electrical stimulation.</i_keyword>
      <i_keyword>Intervention 3: In intervention 3, just after the end of 15 minutes of transcranial electrical stimulation, the electrodes of the electrical stimulation device are separated and the neurofeedback electrodes are connected to the suture points P3, P4. The neurofeedback device will be dual channel Procomb 2 from Canada. Therefore, the source and reference electrodes will be placed on both P3, P4 and ground electrodes on the ear. In neurofeedback therapy, the participant is placed in front of a lip screen and a cartoon is played to him or her as desired. But the difference between this broadcast and the normal broadcast is that the performance and distribution of the cartoon depends on the model of concentration, breathing, and attention of the participant. The participant must, through trial and error and through the feedback given to him by the system, by keeping his concentration, breathing and eye movements, keep the alpha and theta levels in the parietal section in a position where the cartoon is broadcast. Otherwise the image will stop. Carba neurofeedback is done every 35 minutes after stimulation and its purpose is to stabilize the action potential created after the math exercises. At the end of intervention 3 in each session, the baseline is taken again from the participants to examine the changes in alpha, theta and beta 3 in each session. At the end of the eighth session, the participants are taken again from the Wechsler test, and their new math scores will be compared with the math score before the intervention, which will be reported to the researcher by the school. Data will be analyzed by Cohen's recovery percentage and effect size tables and visual analysis.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive abilities and Weakness in math problem- solving. Timepoint: Brain wave recording is started with two baselines from the beginning and is done once after both treatment sessions. But Wechsler test and student math scores are taken only at the beginning and end of the study. Method of measurement: The Wechsler Fourth Edition Scale will be used to measure cognitive abilities using verbal comprehension, perceptual reasoning, working memory, processing speed, and total intelligence scales. To check for changes in math score, math scores from the previous semester and the new semester will be reviewed. To measure the changes of alpha, theta and beta 3 waves at points P3-P4, brain wave recording will be used by recording the EEQ waves of the neurofeedback device.</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>Refah University College</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-29</approval_date>
        <contact_name>Research Ethics Committees of Alzahra University</contact_name>
        <contact_address>Deh- Vanak Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
