<?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>IRCT2017011028199N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-04-27</date_registration>
      <primary_sponsor>vice chancellor for research of Iran University of Medical Science</primary_sponsor>
      <public_title>Effect of Repetetive Transcranial Magnetic  Stimulation(RTMS) on Mild Cognitive Impairment (MCI)</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of  Repetetive Transcranial Magnetic Stimulation(RTMS) on Mild Cognitive Impairment (MCI)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>16</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22928</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Other design features: We will use Closed Packet in both intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mild cognitive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:&#13;
8 patients in this study will be treated with RTMS 2-3 times per week for 8 weeks with every session lasts for 30 minutes. Device for induction of magnitude wave is named Magnature which is made in Denmark .the frequency is above 1 Hz and usually above 10 Hz which has the optimal stimulation effect on postero-lateral prefrontal cortex. &#13;
Intensity:  &#13;
The intensity is the minimum stimulation which is required to induce contraction of small hand muscles observed by a physician or recorded by an electromyogram. This intensity is usually 100 to 120 percent of resting membrane potential of a neuron. &#13;
Time of stimulation: 10 seconds.&#13;
Location of stimulation: left dorsolateral prefrontal cortex which is related to memory.&#13;
 Interval of stimulations: 0.20 seconds. &#13;
Number of stimulation in every sessions: 1000 &#13;
Time of every session: 30 minutes&#13;
Number of sessions: 2-3 sessions per week, up to 8 weeks. &#13;
The treated group are subsequently treated with placebo for the next 8 sessions via voice without magnitude after mentioned cognitive tests ( Mini-Mental State Exam &amp; Montreal Cognitive Assessment) being performed &#13;
Cognitive tests will be performed for both groups at the end of the last session. Intervention 2: Intervention group 2: &#13;
8 patients will be initially treated with placebo for 8 weeks via pure voice without real magnitude wave cognitive tests. Cognitive tests will be performed at the end of the 8th week. The mentioned group will later be treated by real magnitude wave for 8 weeks and mentioned cognitive tests will be repeated.</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>Ensieh Malekdar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valadi street, Valiasr square,  Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1593748711</zip>
        <telephone>+98 21 8214 1718</telephone>
        <email>THEFIRSTMAJID@YAHOO.COM info@ent-hns.org</email>
        <affiliation>Firoozgar hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Masood Mehrpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valadi street, Valiasr square ,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1593748711</zip>
        <telephone>+98 21 8214 1718</telephone>
        <email>mehrpour.m@iums.ac.ir</email>
        <affiliation>Firoozgar hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria : &#13;
Patients with MCI(mild cognitive impairement) based on  complaint of memory impairment with  MMSE(mini mental status exam) score of more than 24 / 30 ؛ MCA(Montreal Cognitive Asessment)score of more than 26 / 30.&#13;
&#13;
 Exclusion criteria : Dementia  confirmed with  MMSE score of less than 24 /30؛ MCA score of less than 26 / 30 ؛Other treatable causes  of dementia including serum B12 level below 200 Pg/ml ؛ hypothyroidism with thyroid stimulating hormone of above 6 uU/ml؛ any lesion on brain computed tomography scan  explaining forgetfulness ؛ Depression rolled out in the recruited population with Beck screening test 14-28.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mild cognitive disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1:&#13;
8 patients in this study will be treated with RTMS 2-3 times per week for 8 weeks with every session lasts for 30 minutes. Device for induction of magnitude wave is named Magnature which is made in Denmark .the frequency is above 1 Hz and usually above 10 Hz which has the optimal stimulation effect on postero-lateral prefrontal cortex. &#13;
Intensity:  &#13;
The intensity is the minimum stimulation which is required to induce contraction of small hand muscles observed by a physician or recorded by an electromyogram. This intensity is usually 100 to 120 percent of resting membrane potential of a neuron. &#13;
Time of stimulation: 10 seconds.&#13;
Location of stimulation: left dorsolateral prefrontal cortex which is related to memory.&#13;
 Interval of stimulations: 0.20 seconds. &#13;
Number of stimulation in every sessions: 1000 &#13;
Time of every session: 30 minutes&#13;
Number of sessions: 2-3 sessions per week, up to 8 weeks. &#13;
The treated group are subsequently treated with placebo for the next 8 sessions via voice without magnitude after mentioned cognitive tests ( Mini-Mental State Exam &amp; Montreal Cognitive Assessment) being performed &#13;
Cognitive tests will be performed for both groups at the end of the last session</i_keyword>
      <i_keyword>Intervention group 2: &#13;
8 patients will be initially treated with placebo for 8 weeks via pure voice without real magnitude wave cognitive tests. Cognitive tests will be performed at the end of the 8th week. The mentioned group will later be treated by real magnitude wave for 8 weeks and mentioned cognitive tests will be repeated</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Evaluation of change in cognitive function. Timepoint: From one week before intervention &amp; placebo to one week after intervention &amp; placebo. Method of measurement: Questionnaire includes Mini Mental Cognitive Exam and Montreal Cognitive Assessment.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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>vice chancellor for research of Iran University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-06-14</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>,Shahid Hemmat Highway  .Tehran,1449614535,IRAN Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
