<?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>IRCT20251027067782N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-11-27</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of repetitive magnetic stimulation on movement and swallowing in patients with ischemic stroke</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of repetitive extracerebral magnetic stimulation (rTMS) in improving motor performanceand swallowing disorders in patients with ischemic stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>205</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/87226</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: This study is a semi-experimental (before–after) design in which ischemic stroke patients are evaluated before and after receiving repetitive transcranial magnetic stimulation (rTMS) in terms of motor and swallowing function. Due to the therapeutic nature of the intervention and ethical and practical limitations in establishing a control group, a before–after design was chosen so that each patient serves as their own control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ischemic Stroke.</hc_freetext>
      <i_freetext>Intervention group: Patients with ischemic stroke receive repetitive transcranial magnetic stimulation according to the standard protocol. The intervention consists of stimulation of the primary motor cortex of the affected hemisphere at a frequency of ten hertz, an intensity equal to one hundred percent of the motor threshold, a total of one thousand five hundred pulses per session, and an approximate duration of twenty minutes. Treatment sessions are delivered five times per week for two consecutive weeks. No additional intervention is applied during the treatment period..</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to the sensitive nature of individual patient data in ischemic stroke populations and the substantial risk of re-identification even after de-identification procedures, the ethics committee has imposed specific restrictions on data sharing. To ensure maximum confidentiality and full compliance with ethical and legal requirements, the individual participant data from this study cannot be publicly shared at this time. No additional information is available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amirali Akbari baghbaderani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 51, Baradaran Ziaei Alley, Before Payambar-e Gharbi, Shahid Mostafa Pazhuhandeh Blvd., Ayatollah Kashani Blvd., Janat Abad-e Jonubi, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1471945815</zip>
        <telephone>+98 21 4404 0483</telephone>
        <email>Amiraliakbri1999@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amirali Akbari baghbaderani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 51, Baradaran Ziaei Alley, Before Payambar-e Gharbi, Shahid Mostafa Pazhuhandeh Blvd., Ayatollah Kashani Blvd., Janat Abad-e Jonubi, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1471945815</zip>
        <telephone>+98 21 4404 0483</telephone>
        <email>Amiraliakbri1999@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmed ischemic stroke by CT or MRI
Presence of motor or swallowing dysfunction after stroke
At least two weeks post-stroke (clinically stable phase)
Ability to attend therapy sessions
Written informed consent obtained</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Hemorrhagic stroke
History of epilepsy or active seizures
Metallic implants or contraindicated medical devices for rTMS
Severe psychiatric or cognitive disorders
Inability to cooperate in therapy sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I63</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebral infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients with ischemic stroke receive repetitive transcranial magnetic stimulation according to the standard protocol. The intervention consists of stimulation of the primary motor cortex of the affected hemisphere at a frequency of ten hertz, an intensity equal to one hundred percent of the motor threshold, a total of one thousand five hundred pulses per session, and an approximate duration of twenty minutes. Treatment sessions are delivered five times per week for two consecutive weeks. No additional intervention is applied during the treatment period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Change in motor function score measured by the Fugl Meyer Assessment from before the intervention to after completion of the intervention. Timepoint: Measurement of motor function at baseline before the start of the intervention and after completion of the full course of repetitive transcranial magnetic stimulation sessions. Method of measurement: Motor function measurement using the Fugl Meyer Assessment administered by a trained rehabilitation specialist.</prim_outcome>
      <prim_outcome>Change in swallowing function score measured by the Functional Oral Intake Scale from before the intervention to after completion of the intervention. Timepoint: Measurement of swallowing function at baseline before the start of the intervention and after completion of the full course of repetitive transcranial magnetic stimulation sessions. Method of measurement: Swallowing function measurement using the Functional Oral Intake Scale administered by a trained speech therapist.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-24</approval_date>
        <contact_name>Biomedical Ethics Committee of Islamic Azad University, Tehran Medical Sciences Branch</contact_name>
        <contact_address>Tehran, Shahid Ghandi St., North of Sadr Bridge, Shariati St., Islamic Azad University, Tehran Medical Sciences Branch Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
