<?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>IRCT20230919059470N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-07</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effectiveness of Transcranial direct current stimulation (tDCS) on the working memory and narrative discourse of healthy elderly</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of Transcranial direct current stimulation (tDCS) on the working memory and narrative discourse of healthy elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72718</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Each person will be placed in two test (A) or control (B) groups using the random block method. The division of people into the test group or the control group will be done using blocks of 4 and the random replacement method, as follows (where A represents the test person and B represents the control person) and the allocation sequence will be determined.
ABBABABABAABABABBAABBBAABAABBAABABABAB
The type of intervention based on the predetermined sequence is written inside the envelopes in the opaque package and the envelopes will be numbered in order. After having the necessary conditions and willingness to participate in the study, each person will receive an envelope and the researcher will act based on the content inside the envelope, Blinding description: The subjects of the study group are treated in the intervention process in each session by placing the anode electrode on the F3 area of ​​the brain and with an intensity of 2 milliampers. The cathode electrode is placed in the right upper orbital region of the person. In the control group, the electrodes are placed in the desired areas, but after 1 minute and after reaching the intensity of 1 milliamperes, the device is automatically cut off, but the person is not aware and the sham stimulation conditions continue. It should be noted that none of the participants will be informed about the type of real and sham stimulation session.</study_design>
      <phase>N/A</phase>
      <hc_freetext>working memory and narrative discourse of healthy elderly.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 18 healthy elderly people are subjected to brain stimulation for 20 minutes and in 5 days with a transcranial brain stimulation device and at the same time they perform the N-back test with a computer. The intensity of the stimulation with the device is 2 milliamperes. Intervention 2: Control group: 18 healthy elderly people are subjected to brain stimulation for 20 minutes and in 5 days with a transcranial brain stimulation device and at the same time they perform the N-back test with a computer. When the intensity of 1 milliampere is reached, the device is cut off.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bahare rezai</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation Sciences, Hamadan University of Medical Sciences, Shahid Fahideh St., Hamadan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۸۳۸۶۸۷</zip>
        <telephone>+98 81 3838 1571</telephone>
        <email>rezaeibahareh@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Moshtagh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ramdasht</address>
        <city>Roudsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4481889363</zip>
        <telephone>+98 13 4263 1318</telephone>
        <email>Ali.moshtagh.96@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Elderly people (60-85 years old) and Persian language should prevail.
Based on the Edinburgh test, it should be dominant in right-handed people.
Do not have irreparable visual or auditory sensory defects, that is, at a comfortable listening level (20 to 45 dB with hearing aids) and the vision can understand the message. The presence of a history of low vision and hearing loss is checked based on observation and interview with the patient's companions. If the visual and hearing impairment is to the extent that it cannot be compensated by auxiliary devices (glasses and hearing aids), the person will not be included in the study.
The person's cognitive status and intelligence based on the MMSE test should be normal. (Score 24 and above.)
Based on the examination of the medical record, they do not have a history of neurological and psychiatric diseases and speech and language.
No dependence on alcohol and drugs.
Not using drugs that affect the nervous system (such as antidepressants and sleeping pills)
Absence of any type of obstacle for the operation of the tDCS device, such as the presence of certain metals</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: 18 healthy elderly people are subjected to brain stimulation for 20 minutes and in 5 days with a transcranial brain stimulation device and at the same time they perform the N-back test with a computer. The intensity of the stimulation with the device is 2 milliamperes.</i_keyword>
      <i_keyword>Control group: 18 healthy elderly people are subjected to brain stimulation for 20 minutes and in 5 days with a transcranial brain stimulation device and at the same time they perform the N-back test with a computer. When the intensity of 1 milliampere is reached, the device is cut off.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Working memory. Timepoint: at the beginning of the study (before the start of the intervention) and after the end of the study (after the last day of the intervention) and 1 month after the end of the intervention. Method of measurement: N-back test.</prim_outcome>
      <prim_outcome>Narrative discourse. Timepoint: at the beginning of the study (before the start of the intervention) and after the end of the study (after the last day of the intervention) and 1 month after the end of the intervention. Method of measurement: Persian narrative discourse evaluation test.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-15</approval_date>
        <contact_name>Ethics Committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>5th floor, Central Headquarters of University of Medical Sciences, Shahid Fahmideh Blvd., Hamadan, Hamadan Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
