<?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>IRCT20210320050750N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-31</date_registration>
      <primary_sponsor>The University of Lorestan</primary_sponsor>
      <public_title>Comparison of the effectiveness of brain training and CES in patients with MCI</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of the effectiveness of cognitive rehabilitation therapy based on brain training, cranial electrical stimulation and their combination on attention, memory, language and visuospatial processing of patients with mild cognitive impairment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55328</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Other design features: Use of clinical cue with the aim of identifying and accurately diagnosing cognitive defects of patients and creating a special treatment protocol for each patient, Blinding description: In relation to blinding participants; Patients in each group are interviewed individually before entering the intervention and the treatment is fully explained to them, then the patient is free to sign the consent form or not. At this stage and during the intervention, patients in each group are not aware of the intervention provided for other patients and also none of the patients will be in contact with each other at any stage.
In relation to blinding the outcome assessor; The trained Addenbrooke's  Cognitive examiner is responsible for evaluating patients at each stage of the intervention (baseline, intervention, follow-up). The examiner is not aware of the type of intervention presented to the patients and is told to evaluate the referred patients using the Addenbrooke's Cognitive Examination and to provide the therapist with the patient's test score. Therefore, the examiner is responsible for evaluating the referred patients for only 20 minutes and is not aware of the research process and intervention provided for each patient. 
In relation to data analyzer blinding; Statistical analysis is performed by a statistical expert in such a way that the  Addenbrooke test scores in different stages (baseline, intervention, follow-up) are presented to each patient as a separate folder and the statistical specialist is only responsible for drawing the charts. The researcher is responsible for analyzing and interpreting the results and graphs.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mild cognitive impairment.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Receiving brain training by pencil-paper method. Pencil-paper exercises are offered for 10 sessions twice a week for 20 minutes. Intervention 2: Intervention group 2: Receiver of cranial electrical stimulation with intensity of 5 mA and frequency of 350 Hz for 30 minutes for 10 sessions twice a week. Intervention 3: Third intervention group: This group is a double combination of the first and second group interventions. Receiver of 10 sessions of brain training and cranial electrical stimulation session (current of 5 mA and frequency of 350 Hz) as a companion of 30 minutes each session twice a week .</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:
All research documents including the data file of the participants without name and surname, consent, executive protocol and statistical tables and graphs will be shared after the end of the study.

When:
The access period starts 6 months after the publication of the articles taken out of the study.

To whom:
All employed researchers and students of domestic and foreign universities

Conditions:
In order to compare with the results of other similar studies / no other statistical analysis is possible on the presented results.

Where to obtain:
Contact the main researcher (Parisa Pourabadei) via e-mail to:
ppourabadi@gmail.com

How to obtain:
Applicants can send their application to the main researcher (Parisa Pourabadei) by email. They will be answered in less than 72 hours.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa Pourabadei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Postal Code: 8173663731, Alley No. 7, Nazar Sharghi Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8173663731</zip>
        <telephone>+98 31 3626 6963</telephone>
        <email>pourabadei.pa@fh.lu.ac.ir</email>
        <affiliation>The University of Lorestan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parisa Pourabadei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Postal code:8173663731, Alley NO.7 , East Nazar St.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8173663731</zip>
        <telephone>+98 31 3626 6963</telephone>
        <email>pourabadei.pa@fh.lu.ac.ir</email>
        <affiliation>The University of Lorestan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Receive a diagnosis of mild cognitive impairment disorder
Get a quorum score on the Addenbrooke's Cognitive Examination-R
Not having mental retardation and other types of dementia
Not having seizures and epilepsy</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissatisfaction of the patient or her/ his family
Occurrence of seizures when receiving cranial electrical stimulation
Absence from a treatment session</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G31.84</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mild cognitive impairment, so stated</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Receiving brain training by pencil-paper method. Pencil-paper exercises are offered for 10 sessions twice a week for 20 minutes.</i_keyword>
      <i_keyword>Intervention group 2: Receiver of cranial electrical stimulation with intensity of 5 mA and frequency of 350 Hz for 30 minutes for 10 sessions twice a week</i_keyword>
      <i_keyword>Third intervention group: This group is a double combination of the first and second group interventions. Receiver of 10 sessions of brain training and cranial electrical stimulation session (current of 5 mA and frequency of 350 Hz) as a companion of 30 minutes each session twice a week .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Use them with a score of 87 to 85 in Addenbrooke's Cognitive Examination. Timepoint: In the baseline phase, measure once a week for three weeks, In the measurement intervention phase at the end of sessions 2, 4, 6, 8 and 10 and in follow-up one month after the last session. Method of measurement: Addenbrookes;s Cognitive Exaxmination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Attention score on Addenbrooke's cognitive examination. Timepoint: In the baseline phase, measure once a week for three weeks, In the measurement intervention phase at the end of session 2,4,6,8,10 and in follow-up one month after the last session. Method of measurement: Addenbrooke's Cognitive Examination.</sec_outcome>
      <sec_outcome>Memory score on the Addenbrooke's Cognitive Examination. Timepoint: In the baseline phase, measure once a week for three weeks, In the measurement intervention phase at the end of session 2,4,6,8,10 and in follow-up one month after the last session. Method of measurement: Addenbrooke's Cognitive Examination.</sec_outcome>
      <sec_outcome>Language score on the Addenbrooke's Cognitive Examination. Timepoint: In the baseline phase, measure once a week for three weeks, In the measurement intervention phase at the end of session 2,4,6,8,10 and in follow-up one month after the last session. Method of measurement: Addenbrooke's Cognitive Examination.</sec_outcome>
      <sec_outcome>Visual-spatial processing score on the Addenbrooke's Cognitive Examination. Timepoint: In the baseline phase, measure once a week for three weeks, In the measurement intervention phase at the end of session 2,4,6,8,10 and in follow-up one month after the last session. Method of measurement: Addenbrooke's Cognitive Examination.</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>The University of Lorestan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-27</approval_date>
        <contact_name>research ethics committees of lorestan university of medical sciences</contact_name>
        <contact_address>University of Medical Sciences, Shahid Anoushirvan Rezaei Square, Moalem St., Lorestan, Khorram Abad khoramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
