<?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>IRCT20190616043901N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-18</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of working memory training in Alzheimer disease.</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of working memory training on brain waves changes in early stage of Alzheimer disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40219</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: patients will be subdivided into intervention and control groups by flipping a coin (simple individual randomization).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Alzeimer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: participants in the training group attend 12 sessions (30 minutes each). the sessions take place 3 days a week for 4 weeks in row (in another words for 1 month). The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence. The load factor n can be adjusted to make the task more or less difficult.To clarify, the visual n-back test is similar to the classic memory game of "Concentration". However, instead of different items that are in a fixed location on the game board, there is only one item, that appears in different positions on the game board during each turn and subject must remember if the current location of item matches with n step earlier in the sequence. "N-1" means that you have to remember the position of the item, one turn back. "N-2" means that you have to remember the position of the item two turns back, and so on. if the score of subject is more than 75% he or she will go to next n-back level. if the score is between 50%-75% he/she remain the current level. and if the score is less than 50% he/she will go one level back. Intervention 2: Control group: the control group is not under any intervention or treatment.</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:
the data about main consequence (dependent variables) will be shared

When:
6 Month after the conclusion get published

To whom:
limitless

Conditions:
there is no limit

Where to obtain:
email: pegah.dehghan14@gmail.com
It will be also published as a thesis and will be available in library of Shahid Bahonar University

How to obtain:
first the responsible of research must approve the request.then data will be sent.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hosein-ali Ebrahimi meimand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Center of Brain Disease Research., Shafa hospital., Kosar ave,. Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618751151</zip>
        <telephone>+98 34 3212 4727</telephone>
        <email>hebrahimi@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hosein Ali Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Center of Neurology Research , Shafa Hospital,. Kosar ave.</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۶۱۸۷۵۱۱۵۱</zip>
        <telephone>+98 34 2345 3032</telephone>
        <email>hebrahimi@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All Alzheimer patients which are in the early stage of their disease
participants are right hand
participants have normal vision
being over 50 years old</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Epilepsy,
use of psychiatric medication
any kind of degenerative neurological pathway</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Alzheimer's disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: participants in the training group attend 12 sessions (30 minutes each). the sessions take place 3 days a week for 4 weeks in row (in another words for 1 month). The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence. The load factor n can be adjusted to make the task more or less difficult.To clarify, the visual n-back test is similar to the classic memory game of "Concentration". However, instead of different items that are in a fixed location on the game board, there is only one item, that appears in different positions on the game board during each turn and subject must remember if the current location of item matches with n step earlier in the sequence. "N-1" means that you have to remember the position of the item, one turn back. "N-2" means that you have to remember the position of the item two turns back, and so on. if the score of subject is more than 75% he or she will go to next n-back level. if the score is between 50%-75% he/she remain the current level. and if the score is less than 50% he/she will go one level back.</i_keyword>
      <i_keyword>Control group: the control group is not under any intervention or treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Alpha peak. Timepoint: 3 day before and 3 day after the intervention. Method of measurement: electroencephalograph.</prim_outcome>
      <prim_outcome>Alpha absolute power. Timepoint: 3 day before and 3 day after the intervention. Method of measurement: electroencephalograph.</prim_outcome>
      <prim_outcome>Relative Alpha power. Timepoint: 3 day before and 3 day after the intervention. Method of measurement: electroencephalograph.</prim_outcome>
      <prim_outcome>Beta absolute power. Timepoint: 3 day before and 3 day after the intervention. Method of measurement: electroencephalograph.</prim_outcome>
      <prim_outcome>Relative beta power. Timepoint: 3 day before and 3 day after the intervention. Method of measurement: electroencephalograph.</prim_outcome>
      <prim_outcome>Working memory. Timepoint: 3 day before and 3 day after the intervention. Method of measurement: digit span questionare.</prim_outcome>
      <prim_outcome>Severity of dementia. Timepoint: 3 day before and 3 day after the intervention. Method of measurement: mini-mental status examination 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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-25</approval_date>
        <contact_name>Ethic Committee of Shahid Bahonar University of Medical Science</contact_name>
        <contact_address>Shahid Bahonar University., Pajoohesh Sq., Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
