<?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>IRCT20221031056347N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-15</date_registration>
      <primary_sponsor>University of Isfahan</primary_sponsor>
      <public_title>Comparing the Effects of Cognitive Training and Repetitive Transcranial Magnetic Stimulation On Improvement of Cognitive Functions and Activities of Daily Living Among Mild Cognitive impairment Individuals</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effects of Cognitive Training and Repetitive Transcranial Magnetic Stimulation On Improvement of Cognitive Functions and Activities of Daily Living Among Mild Cognitive impairment Individuals with High and Low Levels of Cognitive Reserve: An Embedded Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66583</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mild cognitive impairment.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: the group of "participants with high cognitive reserve" who receive "cognitive training intervention" for 10 sessions. Cognitive intervention is carried out twice a week and lasts a total of 5 weeks. The content of various training sessions is in the following six areas:1. Memory (Episodic memory)2. Attention3. Executive Function (cognitive flexibility)4. Executive Function (inhibitory control)5. Executive Function (working memory)6. Language (word finding). Intervention 2: The second intervention group: the group of "participants with low cognitive reserve" who receive "cognitive training intervention" for 10 sessions. Cognitive intervention is carried out twice a week and lasts a total of 5 weeks. The content of various training sessions is in the following six areas:1. Memory (Episodic memory)2. Attention3. Executive Function (cognitive flexibility)4. Executive Function (inhibitory control)5. Executive Function (working memory)6. Language (word finding). Intervention 3: The third intervention group: the group of "participants with high cognitive reserve" who receive "rTMS intervention" for 10 sessions. The rTMS intervention consists of two repeated sessions of transcranial magnetic stimulation during the week, each session will last for about 20 minutes, which will last for a total of 5 weeks. Intervention 4: The fourth intervention group: the group of "participants with low cognitive reserve" who receive "rTMS intervention" for 10 sessions. The rTMS intervention consists of two repeated sessions of transcranial magnetic stimulation during the week, each session will last for about 20 minutes, which will last for a total of 5 weeks.</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:
Only part of the data such as information about the main outcome or the like can be shared.

When:
The access period starts 6 months after the results are published

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
Request by email only

Where to obtain:
The request should be sent by email and in person to:
mohammade.ghaderi@gmail.com

How to obtain:
After receiving the email, the researcher will be answered as soon as possible

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Ghaderi Rammazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Isfahan,  Azadi square, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>817467344</zip>
        <telephone>+98 34 3322 7825</telephone>
        <email>mohammade.ghaderi@yahoo.com</email>
        <affiliation>Isfahan University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Ghaderi Rammazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alley  9, Yas St</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7617471736</zip>
        <telephone>+98 34 3322 7135</telephone>
        <email>mohammade.ghaderi@gmail.com</email>
        <affiliation>Isfahan University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least 60 years old
NUCOG score between 75 and 85</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severe physical or mental disability that prevents the person from actively participating in the study
Not having the minimum level of education (reading and writing literacy)</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: the group of "participants with high cognitive reserve" who receive "cognitive training intervention" for 10 sessions. Cognitive intervention is carried out twice a week and lasts a total of 5 weeks. The content of various training sessions is in the following six areas:1. Memory (Episodic memory)2. Attention3. Executive Function (cognitive flexibility)4. Executive Function (inhibitory control)5. Executive Function (working memory)6. Language (word finding)</i_keyword>
      <i_keyword>The second intervention group: the group of "participants with low cognitive reserve" who receive "cognitive training intervention" for 10 sessions. Cognitive intervention is carried out twice a week and lasts a total of 5 weeks. The content of various training sessions is in the following six areas:1. Memory (Episodic memory)2. Attention3. Executive Function (cognitive flexibility)4. Executive Function (inhibitory control)5. Executive Function (working memory)6. Language (word finding)</i_keyword>
      <i_keyword>The third intervention group: the group of "participants with high cognitive reserve" who receive "rTMS intervention" for 10 sessions. The rTMS intervention consists of two repeated sessions of transcranial magnetic stimulation during the week, each session will last for about 20 minutes, which will last for a total of 5 weeks.</i_keyword>
      <i_keyword>The fourth intervention group: the group of "participants with low cognitive reserve" who receive "rTMS intervention" for 10 sessions. The rTMS intervention consists of two repeated sessions of transcranial magnetic stimulation during the week, each session will last for about 20 minutes, which will last for a total of 5 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The participant's score on the Neuropsychiatry Unit Cognitive Assessment Tool (NUCOG). Timepoint: Before intervention, Session 3, Session 7, and Session 10. Method of measurement: The Neuropsychiatry Unit Cognitive Assessment Tool (NUCOG).</prim_outcome>
      <prim_outcome>The participant's score on the Instrumental Activities of Daily Living Scale (IADL). Timepoint: Before intervention, Session 3, Session 7, and Session 10. Method of measurement: Instrumental Activities of Daily Living Scale (IADL).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cognitive functions. Timepoint: Before starting the intervention and in sessions 3, 7, and 10. Method of measurement: NUCOG TEST.</sec_outcome>
      <sec_outcome>Activities of daily living. Timepoint: Before starting the intervention and in sessions 3, 7, and 10. Method of measurement: Instrumental activities of daily living scale.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Cognitive Science and Technologies Council (CSTC)</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Cognitive Science and Technologies Council (CSTC)</source_name>
      <source_name>Cognitive Science and Technologies Council (CSTC)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-18</approval_date>
        <contact_name>Research Ethics Committees of University of Isfahan</contact_name>
        <contact_address>No 325, 3rd Floor, Central Building, University of Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-07</approval_date>
        <contact_name>Research Ethics Committees of Kerman University of Medical Sciences</contact_name>
        <contact_address>Kerman University of Medical Sciences, Medical University Campus,     Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
