<?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>IRCT20230910059393N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-11</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>investigation the effectiveness of low-frequency  pulsed magnetic field in the treatment of obsessive-compulsive disorder</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effects of low-frequency pulsed magnetic field adjuvant therapy in patients with obsessive-compulsive disorder (OCD)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72661</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Patients entering the study are divided into two groups based on the random allocation law (by lottery and without replacement and considering the sequence). The study will be conducted as a single-blind study so that the patients will be completely unaware of the nature of the adjuvant treatment and how the groups will be randomized, Blinding description: the blinding of the study will  be done bilaterally/so that the patients will be completely unaware of the nature of the adjuvant treatment and how the groups will be randomized. considering that this is an auxiliary treatment and treatment must be done correctly.the doctor dose not know the patient's condition and  the doctor is also blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>obsessive-compulsive disorder (OCD).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to the treatment according to the protocol of the reference book by therapy sessions and drug therapy, the low-frequency pulsed magnetic field (LFMPF) method is performed using a Transcranial magnetic stimulator. Stimulation parameters in the intervention group for 3 weeks are performed as follows: frequency 10, 15, 20 Hz, with an intensity of 0.1 to 0.4 milliTesla and for 30 minutes (1200 pulses per day) at 100% of the rest movement threshold, once in day, 3 days a week. Intervention 2: Control group: Patients will be treated according to the protocol of the reference book and in the form of therapy sessions and drugs.</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 data can be shared after de-identification.

When:
One year after the results are published

To whom:
Access to the data will be free for all researchers in the field of psychiatry and psychology.

Conditions:
Only the obligation to cite the source is required and there are no other conditions

Where to obtain:
The data of this research can be made available after request by e-mail.

How to obtain:
The applicant may access the data after one month by stating the purpose and reason for the need for the data documented in this research, if there is no interference with the above-mentioned criteria.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Kheradmand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleqani Hospital, next to Shahid Beheshti University of Medical Sciences, Shahid Arabi St, Yemen St, Shahid Chamran Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985711151</zip>
        <telephone>+98 21 230311</telephone>
        <email>dr.alikheradmand@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Kheradmand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleqani Hospital, next to Shahid Beheshti University of Medical Sciences, Shahid Arabi St, Yemen St, Shahid Chamran Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985711151</zip>
        <telephone>+98 21 230311</telephone>
        <email>dr.alikheradmand@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>consent to participate in the study
18 to 60 years
at least moderate intensity based on the obsessive compulsive scale
initial diagnosis of OCD based on diagnostic and statistical guidelines for mental disorder.fifth edition</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>history of epilepsy
drug  abuse
significant head injury or any neurosurgery
metal implants and pacemakers
those who received an electrical shock in the last 6 months
people with co-occurring  psychiatric disorder other than depression</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F42</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obsessive-compulsive disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In addition to the treatment according to the protocol of the reference book by therapy sessions and drug therapy, the low-frequency pulsed magnetic field (LFMPF) method is performed using a Transcranial magnetic stimulator. Stimulation parameters in the intervention group for 3 weeks are performed as follows: frequency 10, 15, 20 Hz, with an intensity of 0.1 to 0.4 milliTesla and for 30 minutes (1200 pulses per day) at 100% of the rest movement threshold, once in day, 3 days a week</i_keyword>
      <i_keyword>Control group: Patients will be treated according to the protocol of the reference book and in the form of therapy sessions and drugs.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Yale Brown Obsessive Compulsive Scale Score (YBOCS). Timepoint: 30 days after the last round of interventions. Method of measurement: Interviewing the patient and performing the Yale Brown Obsessive-Practice Scale (YBOCS) test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hamilton Depression Rating Scale Score. Timepoint: 30 days after the last round of interventions. Method of measurement: Interviewing the patient and performing Hamilton Test.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-04-15</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Faculty of Medicine, Shahid Beheshti University of Medical Sciences, next to Shahid Beheshti University of Medical Sciences, Shahid Arabi Street, Yemen Street, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
