<?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>IRCT20210608051514N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-08</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>treatment for schizophrenia patients: double-blind randomized controlled trial study</public_title>
      <acronym></acronym>
      <scientific_title>The impact of prefrontal tRNS on schizophrenia clinical symptoms and cognitive deficits</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59059</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Subjects are selected from Convenience judgmental Sampling method ,They will also be randomly assigned to the desired groups. then which subjects are assigned to the two groups of control and experiment by tossing coins.This method is used for two-group clinical trials, according to which one group is called a lion, and the other is called a line, and thus the number of coin samples is tossed, Blinding description: In this study, the clinical evaluator and therapist will be blind to assigning subjects to control and experimental groups. In addition, we use the clinical evaluator separately for baseline assessments and follow-up, and the therapist separately for treatment.Subjects will also be assigned to control groups or blind experiments, so that subjects will not meet outside of the sessions and will visit at times when no other subjects will be present.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group will receive random stimulation treatment with a frequency of 100_640 Hz, with an average of 1 mA and a range of 2 mA for 10 sessions of 20 minutes. Intervention 2: The control group will receive random stimulation treatment with a frequency of 100_640 Hz, with an average of 1 mA and a range of 2 mA for 10 sessions of 30 seconds.</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 information of individuals except names and confidential information will be published at the end of the research. Publishable information including: treatment changes, results of questionnaires, statistical results of analyzes, dosage and medication used

When:
The results of this research will be published three months after the end of the research.

To whom:
All researchers, researchers, colleagues, and others

Conditions:
To carry out similar projects and if all the material and intellectual rights of researchers are observed.

Where to obtain:
Contact the following email address to receive the documentation: Farahnaz Yousefi Master of Clinical Psychology farahnaz.yosefi76@gmail.com Address: Department of Clinical Psychology and Psychiatry, Beheshti Hospital, Ark Gate, Chahar Ra Saadi, Zanjan Province

How to obtain:
The data will be provided to the applicant after receiving the e-mail of the applicant and observing the material and intellectual rights of the researchers.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohsen Dadashi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Psychology and Psychiatry, Beheshti Hospital, Ark Gate, Chahar Ra Saadi, Zanjan Province</address>
        <city>zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7531974143</zip>
        <telephone>+98 21 8670 5504</telephone>
        <email>mohsen.dadashi@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohsen Dadashi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Psychology and Psychiatry, Beheshti Hospital, Ark Gate, Chahar Ra Saadi, Zanjan Province</address>
        <city>zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7531974143</zip>
        <telephone>+98 21 8675 6604</telephone>
        <email>mohsen.dadashi@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- Having the ability of informed consent to participate in research
2_Have a minimum age of 18 and a maximum of 65 years
3_have a diagnosis of schizophrenia or schizoaffective disorder
4_ The same dose and drug used before the start and during the research
5_ Being right-handed
6_ Stabilization in drug treatment for at least 7 weeks</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1_Have a history of suicide and abuse of alcohol and substances other than caffeine and tobacco
2_Have a history of neurological diseases
3_Have a disease related to the scalp
4_Have a history of head trauma
5_ Existence of device or tool in the head
6- Leaving the research after being absent in two consecutive sessions
7- Pregnancy or breastfeeding</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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group will receive random stimulation treatment with a frequency of 100_640 Hz, with an average of 1 mA and a range of 2 mA for 10 sessions of 20 minutes.</i_keyword>
      <i_keyword>The control group will receive random stimulation treatment with a frequency of 100_640 Hz, with an average of 1 mA and a range of 2 mA for 10 sessions of 30 seconds.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Negative symptoms:Theoretical definition: It is one of the clinical symptoms in schizophrenia that includes superficial emotion, poor speech, lack of motivation, unhappiness and social transgression.Operational definition: The score that a person gets from the positive and negative symptoms of schizophrenia.Positive symptoms: Theoretical definition includes delusions, delusions, disturbed speech, and disturbed behavior that persist throughout a one-month period.Operational definition: The score that a person gets from the positive and negative symptoms of schizophrenia. Timepoint: Pre-test-post-test-one-month follow-up-3 moth follow-up. Method of measurement: The score that a person gets from the questionnaire for measuring positive and negative symptoms in schizophrenia.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Working memory:Theoretical definition: means the ability to store and manipulate information in memory, which is an essential prerequisite for complex cognitive tasks such as learning, reasoning and comprehension. Timepoint: Pre-test-post-test-one-month follow-up_2 month follow-up. Method of measurement: The score that a person gets from the working memory test in the CANTAB collection.</sec_outcome>
      <sec_outcome>Executive function: Theoretical definition: A general structure that encompasses a wide range of cognitive processes and behavioral abilities that include reasoning, problem solving, planning, organizing, working memory, ordering, the ability to pay constant attention, deal with interference, benefit from feedback, and practice. Includes multitasking. Timepoint: Pre-test-post-test-one-month follow-up_2 month follow-up. Method of measurement: The score that a person gets from the executive function measurement test in the CANTAB collection.</sec_outcome>
      <sec_outcome>Emotion Recognition: A Theoretical DefinitionThe ability to recognize people's emotions through non-verbal expression such as face, voice, or gestures and body movements is a key ability in social interactions and a prerequisite for understanding and predicting and responding appropriately to one's behavior. Timepoint: Pre-test-post-test-one-month follow-up-two-month follow-up. Method of measurement: The score that a person gets from the emotional recognition test in the CANTAB collection.</sec_outcome>
      <sec_outcome>DepressionTheoretical definition: Depression is a transient or long-term decline in mood. The main characteristic is the feeling of dissatisfaction, which means lack of interest or lack of feeling of pleasure for the activities that the person already enjoys. Timepoint: Pre-test-post-test-one-month follow-up_2 month follow-up. Method of measurement: A person's score on the Revised Depression Scale.</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-21</approval_date>
        <contact_name>Ethics Committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti Hospital, Ark Gate, Saadi Crossroads, Zanjan Province zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
