<?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>IRCT20180317039116N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-10</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>effects of tDCS on cognitive functions</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of tDCS with conventional occupational Therapy in Improving cognitive functions in Patients with schizophrenia.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30313</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: by using a coin, Blinding description: To eliminate the difference in the sense of initiating electrical stimulation between the groups, the control group will only receive electrical stimulation in the first 30 seconds.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, tDCS device will be used to stimulate cortex. The intervention will consist of 6 sessions, each lasting for 20 minutes. The anode electrode will be placed on F3 region, the left DLPFC, based on an international system of 10-20 EEGs, and the cathode electrode will be placed on the supraorbital area on the opposite side. An electrical stimulation of 2 mAh through the surface of anodic electrode impregnated with a physiologic serum solution, will be applied on F3 cortex. The stimulation was delivered every other day, and all patients perform visual memory tasks during the stimulation. At each session, all participants spend 20 minutes on 3 Tasks of visual memory while receiving brain stimulation.The first task is to remember the order of the cards, then find the cards that their places has changed. The second task is to memorize the cards and then name the deleted cards, and the third task is to remember the cards and then name them all perfectly. Intervention 2: Control group: In this study, tDCS device will be used to stimulate cortex. The intervention will consist of 6 sessions, each lasting for 20 minutes. The anode electrode will be placed on F3 region, the left DLPFC, based on an international system of 10-20 EEGs, and the cathode electrode will be placed on the supraorbital area on the opposite side. At the beginning of the sessions, an electrical stimulation with  2 mAh current would be applied to the F3 cortex for 30 seconds. Patients will not be informed about the interruption of the stimulation.The stimulation was delivered every other day. At each session, all participants spend 20 minutes on 3 Tasks of visual memory while receiving sham stimulation.The first task is to remember the order of the cards, then find the cards that their places have changed. The second task is to memorize the cards and then name the deleted cards, and the third task is to remember the cards and then name them all perfectly.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is there is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elahe Fathi Azar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no.51, Molavi Alley, Abo moslem Ave, masoudiyeh, Afsariye junction,tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>17889-17341</zip>
        <telephone>+98 21 3386 1366</telephone>
        <email>Elahe_fathi91@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elahe Fathi Azar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no7. Molavi alley, abo moslem Ave, masoudiyeh, Afsariye junction, tehran.</address>
        <city>تهران</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1788917341</zip>
        <telephone>+98 21 3386 1366</telephone>
        <email>Elahe_fathi91@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of schizophrenia by a psychiatrist.
At least one year of being hospitalized.
Having MMSE score higher than 17 for ladies and 18 for men.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, tDCS device will be used to stimulate cortex. The intervention will consist of 6 sessions, each lasting for 20 minutes. The anode electrode will be placed on F3 region, the left DLPFC, based on an international system of 10-20 EEGs, and the cathode electrode will be placed on the supraorbital area on the opposite side. An electrical stimulation of 2 mAh through the surface of anodic electrode impregnated with a physiologic serum solution, will be applied on F3 cortex. The stimulation was delivered every other day, and all patients perform visual memory tasks during the stimulation. At each session, all participants spend 20 minutes on 3 Tasks of visual memory while receiving brain stimulation.The first task is to remember the order of the cards, then find the cards that their places has changed. The second task is to memorize the cards and then name the deleted cards, and the third task is to remember the cards and then name them all perfectly.</i_keyword>
      <i_keyword>Control group: In this study, tDCS device will be used to stimulate cortex. The intervention will consist of 6 sessions, each lasting for 20 minutes. The anode electrode will be placed on F3 region, the left DLPFC, based on an international system of 10-20 EEGs, and the cathode electrode will be placed on the supraorbital area on the opposite side. At the beginning of the sessions, an electrical stimulation with  2 mAh current would be applied to the F3 cortex for 30 seconds. Patients will not be informed about the interruption of the stimulation.The stimulation was delivered every other day. At each session, all participants spend 20 minutes on 3 Tasks of visual memory while receiving sham stimulation.The first task is to remember the order of the cards, then find the cards that their places have changed. The second task is to memorize the cards and then name the deleted cards, and the third task is to remember the cards and then name them all perfectly.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive Functions. Timepoint: Before and after intervention. Method of measurement: The Cambridge Neuropsychological Test Automated Battery (CANTAB)- The Loewenstein Occupational Therapy Cognitive Assessment (LOTCA).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Brain activity. Timepoint: before and after intervention. Method of measurement: quantitative electroencephalography.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-29</approval_date>
        <contact_name>Ethics comittee of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Department of Occupational Therapy, The University of Social Welfare and Rehabilitation Sciences, Kodakyar St, Daneshjo Blvd, Evin, Tehran, Iran tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
