<?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>IRCT20100501003844N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-15</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of transcranial direct current stimulation on the clinical outcomes of chronic migraine patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of transcranial direct current stimulation with three approaches, anodal occipital cortex, cathodic occipital cortex and sham on clinical outcomes in patients with chronic migraine</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>144</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67591</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trial study, 114 patients suffering from chronic migraine and resistant to prescribed drugs, who referred to the pain clinic of Velayat Hospital, were randomly selected using the random block method using blocks of 6 and using From the website https://www.sealedenvelope.com, they will be assigned to three groups A, B, C as follows, with an equal allocation ratio in each group by a person not involved in the research.

 1) anodal tDCS of the occipital cortex, anode electrode on the occipital cortex of the dominant side of pain and cathode on the chin, 2) cathodal tDCS of the occipital cortex, cathode electrode on the occipital cortex of the dominant side of pain and anode electrode on the chin of the opposite side, 3) stimulation group fake, Blinding description: To hide the allocation of drugs, they will be placed in a sealed, numbered matte envelope. The preparation of the envelopes and the random sequencing of the allocation will be done by a person not involved in the research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Migraine patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Occipital cortex anodal tDCS groupو the anode electrode is placed on the occipital cortex on the dominant side of the pain and the cathode on the chin on the opposite side. Intervention 2: Intervention group: Cathodal tDCS group of the occipital cortex, the cathode electrode is placed on the occipital cortex of the dominant side of the pain and the anode electrode is placed on the chin of the opposite side. Intervention 3: Control group: The fake stimulation group (sham) also has electrodes with the same arrangement (occipital cortex and chin) and for the duration of the experimental group, with the difference that the electric current will be cut off after 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>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>Cyrus Amir Alavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Velayat Educational and Medical Center, Namjo St.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193713194</zip>
        <telephone>+98 13 3336 8814</telephone>
        <email>cyrusemiralavi@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Cyrus Amir Alavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Velayat Educational and Medical Center, Namjo St.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193713194</zip>
        <telephone>+98 911 131 7398</telephone>
        <email>Cyrusemiralavi@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with chronic migraine
Resistant to drug treatments
Those who experience frequent migraine attacks
Experienced at least 4 attacks per month or 8 days of migraine attacks per month</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of neurological diseases
History of mental disorder and use of antipsychotic and antidepressant drugs
History of treatment with tDCS or other brain stimulation techniques
Taking drugs that block voltage-dependent sodium and calcium channels
Failure of the patient to continue participating in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G43</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Migraine</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Occipital cortex anodal tDCS groupو the anode electrode is placed on the occipital cortex on the dominant side of the pain and the cathode on the chin on the opposite side.</i_keyword>
      <i_keyword>Intervention group: Cathodal tDCS group of the occipital cortex, the cathode electrode is placed on the occipital cortex of the dominant side of the pain and the anode electrode is placed on the chin of the opposite side.</i_keyword>
      <i_keyword>Control group: The fake stimulation group (sham) also has electrodes with the same arrangement (occipital cortex and chin) and for the duration of the experimental group, with the difference that the electric current will be cut off after 30 seconds.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of migraine days per month, pain intensity, frequency of taking painkillers. Timepoint: Before the start of the intervention, after the last session of the intervention and two months after. Method of measurement: Based on questions from the patient.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Intensity of pain. Timepoint: Before the start of the intervention, after the last session of the intervention and two months after. Method of measurement: Using Visual Analogue Scale(VAS), according to patient report.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-13</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>University Research and Technology Vice-Chancellor- in front of 17 Shahrivar Hospital- Shahid Siadati St. -Namjo St. Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
