<?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>IRCT2014110419808N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-11-28</date_registration>
      <primary_sponsor>Hamadan University of Medical Science</primary_sponsor>
      <public_title>Study of Effects of Repetitive Transcranial Magnetic Stimulation on cognition of  Refractory Obsessive Compulsive Disorder Patients</public_title>
      <acronym></acronym>
      <scientific_title>Study of Cognitive Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients of Refractory Obsessive Compulsive Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17618</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>refractory obsessive compulsive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention (refractory transcranial magnetic stimulation (rTMS)): high frequency left (HFL) stimulation will initially be applied at 20 Hz, in 25 trains of 1.5 second duration with a 30 second interval between trains and at 100% of the resting motor threshold (RMT) for a total of 25 minutes of stimulation; Then following this, high frequency right (HFR) stimulation will be applied at the same parameters. Therefore a total of 50 minutes of stimulation will be delivered. Intervention 2: Control (Sham condition): Sham stimulation will be made at the site of active treatment but with only "the side edge" resting on the scalp. It will be administered as high frequency left (HFL) and high frequency right (HFR) for total of 50 minutes, but with the coil angled 45-90 degrees away from the skull in a single-wing tilt position. This method produces sound and somatic sensation (e.g., contraction of scalp muscles) like those with active stimulation but with minimal direct brain effects. Participants will remain blind to the treatment condition.</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>Dr Mehran Shaygan Fard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farshchian Hospital, Mirzade eshghi st</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 3827 4192</telephone>
        <email>mshayganfard@yahoo.com</email>
        <affiliation>Research center for behavioral disorders and substance abuse, Hamadan University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mohammad Haghighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farshchian Hospital, Mirzade Eshghi st</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 3827 4192</telephone>
        <email>haghighi@umsha.ac.ir</email>
        <affiliation>Research center for behavioral disorders and substance abuse, Hamadan university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: have a DSM-IV-TR diagnosis of OCD; ages between 18 and 65 years old; have failed to achieve a clinical response, or did not tolerate, at least 3 separate antidepressant trials of sufficient dose (included clomipramine) and CBT for at least 10 weeks; score of greater than or equal to 17 on the Y-BOCS. Exclusion Criteria: a history of DSM-IV-TR substance dependence in the last 6 months or DSM-IV-TR substance abuse in the last month; a concomitant major unstable medical or neurologic illness or have had a history of seizures; acutely suicidal; being pregnant; metal implants; if they are currently (or in the last 4 weeks) taking more than lorazepam 2 mg daily (or equivalent), monoamine oxidase inhibitors, and/or bupropion (due to its associated increased risk for seizures); Education lower than 2nd class of guidance school</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F42.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mixed obsessional thoughts and acts</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 (refractory transcranial magnetic stimulation (rTMS)): high frequency left (HFL) stimulation will initially be applied at 20 Hz, in 25 trains of 1.5 second duration with a 30 second interval between trains and at 100% of the resting motor threshold (RMT) for a total of 25 minutes of stimulation; Then following this, high frequency right (HFR) stimulation will be applied at the same parameters. Therefore a total of 50 minutes of stimulation will be delivered.</i_keyword>
      <i_keyword>Control (Sham condition): Sham stimulation will be made at the site of active treatment but with only "the side edge" resting on the scalp. It will be administered as high frequency left (HFL) and high frequency right (HFR) for total of 50 minutes, but with the coil angled 45-90 degrees away from the skull in a single-wing tilt position. This method produces sound and somatic sensation (e.g., contraction of scalp muscles) like those with active stimulation but with minimal direct brain effects. Participants will remain blind to the treatment condition.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Rate of cognition in refractory OCD. Timepoint: after 10th, 20th sessions of rTMS or sham. Method of measurement: PASSAT, Digit symbol, Digit Span.</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>Hamadan University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-10-06</approval_date>
        <contact_name>Hamadan University of Medical Sciences</contact_name>
        <contact_address>Shahid Fahmideh Street, Hamedan Hamedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
