<?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>IRCT2015102817867N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-10</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences -</primary_sponsor>
      <public_title>Double stimulation versus single stimulation in rehabilitation of stroke patients using transcranial direct current stimulation</public_title>
      <acronym></acronym>
      <scientific_title>Double point versus single point stimulation in motor rehabilitation of paretic arms among stroke patients using transcranial direct current stimulation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16338</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Ischemic Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Brain stimulation will be done through  a battery-driven constant current stimulator. &#13;
Each patient's brain will be stimulated in five sessions in five consecutive days for about an hour per session. In the first 30 minutes, primary motor cortex will receive real stimulation. Anode electrode will be placed over the injured hemisphere and cathode electrode will be put over the intact hemisphere. In the 10/20 EEG system, primary motor cortex is compatible with C3/C4 points.&#13;
In the second 30 minutes of stimulation, each patient's dorsolateral prefrontal cortex will be stimulated. Anode electrode will be placed over the left dorsolateral prefrontal cortex and cathode electrodes will be put just above the right mid-orbital area. In the 10/20 EEG system, left dorsolateral prefrontal cortex is compatible with F3 point.  &#13;
In both sessions, real stimulation will rise from zero to two milliamperes in 30 seconds, continue at two milliamperes for 30 minutes, and decline from two to zero milliamperes in 30 seconds. Intervention 2: Control group: Brain stimulation will be done through a battery-driven constant current stimulator. Each patient's brain will be stimulated in five sessions in five consecutive days for about an hour per session. In the first 30 minutes, primary motor cortex will receive shaml stimulation. Anode electrode will be placed over the injured hemisphere and cathode electrode will be put over the intact hemisphere. In the 10/20 EEG system, primary motor cortex is compatible with C3/C4 points. In the second 30 minutes of stimulation, each patient's dorsolateral prefrontal cortex will receive sham stimulation. Anode electrode will be placed over the left dorsolateral prefrontal cortex and cathode electrodes will be put just above the right mid-orbital area. In the 10/20 EEG system, left dorsolateral prefrontal cortex is compatible with F3 point. &#13;
In both sessions, stimulation will rise from zero to two milliamperes in 30 seconds, continue at zero milliamperes for 30 minutes, and decline from two to zero milliamperes in 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahram Oveisgharan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Kargar St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8490 2224</telephone>
        <email>shogh2@yahoo.com</email>
        <affiliation>Shariati hospital Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahram Oveisgharan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Kargar St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8490 2224</telephone>
        <email>shahram.oveisgharan@rush.edu</email>
        <affiliation>Shariati hospital Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Stroke patients whose symptoms start within the last 4 days; stroke patients who suffer from upper extremity paresis due to stroke. &#13;
Exclusion criteria: stroke patients with decreased level of consciousness; patients with metal foreign bodies in their heads; patients who do not sign the consent forms; patients who can not come regularly for three months after their first visit;patients with dementia before current stroke; patients who develop severe global aphasia or dementia after stroke.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Brain stimulation will be done through  a battery-driven constant current stimulator. &#13;
Each patient's brain will be stimulated in five sessions in five consecutive days for about an hour per session. In the first 30 minutes, primary motor cortex will receive real stimulation. Anode electrode will be placed over the injured hemisphere and cathode electrode will be put over the intact hemisphere. In the 10/20 EEG system, primary motor cortex is compatible with C3/C4 points.&#13;
In the second 30 minutes of stimulation, each patient's dorsolateral prefrontal cortex will be stimulated. Anode electrode will be placed over the left dorsolateral prefrontal cortex and cathode electrodes will be put just above the right mid-orbital area. In the 10/20 EEG system, left dorsolateral prefrontal cortex is compatible with F3 point.  &#13;
In both sessions, real stimulation will rise from zero to two milliamperes in 30 seconds, continue at two milliamperes for 30 minutes, and decline from two to zero milliamperes in 30 seconds.</i_keyword>
      <i_keyword>Control group: Brain stimulation will be done through a battery-driven constant current stimulator. Each patient's brain will be stimulated in five sessions in five consecutive days for about an hour per session. In the first 30 minutes, primary motor cortex will receive shaml stimulation. Anode electrode will be placed over the injured hemisphere and cathode electrode will be put over the intact hemisphere. In the 10/20 EEG system, primary motor cortex is compatible with C3/C4 points. In the second 30 minutes of stimulation, each patient's dorsolateral prefrontal cortex will receive sham stimulation. Anode electrode will be placed over the left dorsolateral prefrontal cortex and cathode electrodes will be put just above the right mid-orbital area. In the 10/20 EEG system, left dorsolateral prefrontal cortex is compatible with F3 point. &#13;
In both sessions, stimulation will rise from zero to two milliamperes in 30 seconds, continue at zero milliamperes for 30 minutes, and decline from two to zero milliamperes in 30 seconds.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Upper extremity motor capacity. Timepoint: Before intervention, week 2, month 1, month 3. Method of measurement: Fugl-Meyer test.</prim_outcome>
      <prim_outcome>Upper extremity dexterity. Timepoint: Before intervention, week 2, month 1, month 3. Method of measurement: Action Research Arm Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Disability in the daily activities. Timepoint: Before intervention, week 2, month 1, month 3. Method of measurement: Modified Rankin Scale.</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>Tehran University of Medical Sciences -</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-04</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Keshavarz Blvd Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
