<?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>IRCT2017020311885N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-04-01</date_registration>
      <primary_sponsor>Deputy of research and technology,Mazandaran university of medical sciences</primary_sponsor>
      <public_title>Effects of Transcranial direct currency stimulation (tDCS) on the treatment of depressive and anxiety symptoms and improve quality of sleep in patients with chronic renal diseases on dialysis</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Transcranial direct-current stimulation (tDCS) on the treatment of depressive and anxiety symptoms and improve quality of sleep in patients with chronic renal diseases on dialysis- a randomized double-blind placebo controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>85</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12067</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic renal diseases.</hc_freetext>
      <i_freetext>Intervention 1: In main intervention, Subject of two "anxiety and depression" and "sleep disorders" groups were under tDCS.F3-Fp2 protocol was used in main intervention group according to 10-20 system of regions of the brain, the area (F3) Dorsolateral Prefrontal Cortex (DLPFC) was stimulated with anode and contralateral supraorbital (Fp2) under cathodic inhibition. The stimulation started in ascending mode up to 2 mA, and with the enhanced of 2 mA continues for 20 minutes and then, the device automatically shuts down. Intervention 2: in placebo group, Subject of two "anxiety and depression" and "sleep disorders" groups were under tDCS.F3-Fp2 protocol was used in main intervention group according to 10-20 system of regions of the brain, the area (F3) Dorsolateral Prefrontal Cortex (DLPFC) was stimulated with anode and contralateral supraorbital (Fp2) under cathodic inhibition. The stimulation started in ascending mode up to 2 mA, and with the enhanced of 2 mA continues for 30 seconds and then, the device automatically shuts down.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samaneh Farnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mazandaran University of Medical  Sciences</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3326 2646</telephone>
        <email>sfarnia@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical  Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Aalishah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mazandaran University of Medical  Sciences, Dokhaniat street</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>48139-66944</zip>
        <telephone>+98 11 3323 3757</telephone>
        <email>aliaalishah@gmail.com</email>
        <affiliation>Mazandaran University of Medical  Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>History of head trauma in patient; history of epilepsy in patients or their families; past history of bipolar dx. or psychotic dx.; acute suicidal ideas; consumption of neuroleptics during the study; addiction to drugs or alcohol; pregnancy; having metal prosthesis or implant; severe anorexia; past history of neurologic dx. , serious medical illness.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease</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>In main intervention, Subject of two "anxiety and depression" and "sleep disorders" groups were under tDCS.F3-Fp2 protocol was used in main intervention group according to 10-20 system of regions of the brain, the area (F3) Dorsolateral Prefrontal Cortex (DLPFC) was stimulated with anode and contralateral supraorbital (Fp2) under cathodic inhibition. The stimulation started in ascending mode up to 2 mA, and with the enhanced of 2 mA continues for 20 minutes and then, the device automatically shuts down.</i_keyword>
      <i_keyword>in placebo group, Subject of two "anxiety and depression" and "sleep disorders" groups were under tDCS.F3-Fp2 protocol was used in main intervention group according to 10-20 system of regions of the brain, the area (F3) Dorsolateral Prefrontal Cortex (DLPFC) was stimulated with anode and contralateral supraorbital (Fp2) under cathodic inhibition. The stimulation started in ascending mode up to 2 mA, and with the enhanced of 2 mA continues for 30 seconds and then, the device automatically shuts down</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety, depression. Timepoint: Before intervention, after 15 sessions of intervention and 10 days after the end of inervention. Method of measurement: HADS questionnaire.</prim_outcome>
      <prim_outcome>Sleep quality. Timepoint: Before intervention, after 15 sessions of intervention and 10 days after the end of inervention. Method of measurement: PSQI questionnaire.</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>Deputy of research and technology,Mazandaran university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-09-22</approval_date>
        <contact_name>Mazandaran University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Mazandaran University of Medical Sciences, Moallem square Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
