<?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>IRCT20200212046473N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-24</date_registration>
      <primary_sponsor>Cognitive Sciences and Technologies Council</primary_sponsor>
      <public_title>Design and implement of Visual Attention-Based Neurofeedback System</public_title>
      <acronym></acronym>
      <scientific_title>Design and Implement of Second-Generation Neurofeedback System Based on User's Visual Attention, and Evaluate its Efficacy in Memory Enhancement</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45969</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects are selected by random sampling from the community of healthy individuals. After meeting the inclusion and exclusion criteria of the study, they will be assigned by simple randomization method using a random number table into groups of study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Healthy individuals.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group I: Visual attention-based neurofeedback with effective visual stimulus. With the aim of enhancing EEG Alpha power at Oz channel to improve memory, six 30 minutes training sessions over two weeks. The device FlexComp Infiniti (Thought Technology Ltd, Montreal, QC) with the software developed in this study will be used. Intervention 2: Control group I: Conventional neurofeedback without monitoring user's visual attention. With the aim of enhancing EEG Alpha power at Oz channel to improve memory, six 30 minutes training sessions over two weeks. The device FlexComp Infiniti (Thought Technology Ltd, Montreal, QC) with the software developed in this study will be used. Intervention 3: Intervention group II: Visual attention-based neurofeedback with attentional capture mechanism. With the aim of enhancing EEG Alpha power at Oz channel to improve memory, six 30 minutes training sessions over two weeks. The device FlexComp Infiniti (Thought Technology Ltd, Montreal, QC) with the software developed in this study will be used. Intervention 4: Control group II: Conventional neurofeedback by monitoring user's visual attention without attentional capture mechanism. With the aim of enhancing EEG Alpha power at Oz channel to improve memory, six 30 minutes training sessions over two weeks. The device FlexComp Infiniti (Thought Technology Ltd, Montreal, QC) with the software developed in this study will be used.</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 participants' data, after anonymization, will be shared through local and international biosignal online databases. The study protocol, statistical analysis map and informed consent can also be shared.

When:
Data and documents will be available once the results are published for an unlimited period.

To whom:
University researchers

Conditions:
Commitment to mention the source of data and the name of principal investigator for any use, commitment not to use for clinical purposes

Where to obtain:
Correspondence with the representative of principal investigator, Zeynab Khodakarami, with email address: z.khodakarami@gmail.com

How to obtain:
Request review by the representative of principal investigator (2 weeks), sharing the application with the principal investigator (2 weeks), final statement by the representative of principal investigator

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeynab Khodakarami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Biomedical Signal Processing Lab., Faculty of Engineering, Shahed University, Opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 5121 5080</telephone>
        <email>z.khodakarami@gmail.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Firoozabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Medical Physics, Faculty of Medical Sciences, Tarbiat Modares University</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-331</zip>
        <telephone>+98 21 8288 3821</telephone>
        <email>pourmir@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged between 20 to 35 years
Healthy
Have normal or corrected-to-normal vision
University-graduated or student
Neurofeedback-novice</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Have history of neurological diseases (e.g. migraine or epilepsy)
Medication use</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>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group I: Visual attention-based neurofeedback with effective visual stimulus. With the aim of enhancing EEG Alpha power at Oz channel to improve memory, six 30 minutes training sessions over two weeks. The device FlexComp Infiniti (Thought Technology Ltd, Montreal, QC) with the software developed in this study will be used.</i_keyword>
      <i_keyword>Control group I: Conventional neurofeedback without monitoring user's visual attention. With the aim of enhancing EEG Alpha power at Oz channel to improve memory, six 30 minutes training sessions over two weeks. The device FlexComp Infiniti (Thought Technology Ltd, Montreal, QC) with the software developed in this study will be used.</i_keyword>
      <i_keyword>Intervention group II: Visual attention-based neurofeedback with attentional capture mechanism. With the aim of enhancing EEG Alpha power at Oz channel to improve memory, six 30 minutes training sessions over two weeks. The device FlexComp Infiniti (Thought Technology Ltd, Montreal, QC) with the software developed in this study will be used.</i_keyword>
      <i_keyword>Control group II: Conventional neurofeedback by monitoring user's visual attention without attentional capture mechanism. With the aim of enhancing EEG Alpha power at Oz channel to improve memory, six 30 minutes training sessions over two weeks. The device FlexComp Infiniti (Thought Technology Ltd, Montreal, QC) with the software developed in this study will be used.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Working memory performance. Timepoint: Before the intervention in the pretest session, after the intervention in the posttest session. Method of measurement: Cognitive assessment of static and dynamic working memory.</prim_outcome>
      <prim_outcome>Brain neural activity. Timepoint: Before the intervention in the pretest session, during the intervention within neurofeedback training sessions, after the intervention in the posttest session. Method of measurement: Recording EEG signals.</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>Cognitive Sciences and Technologies Council</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-09</approval_date>
        <contact_name>Research Ethics Committee of Tarbiat Modares University</contact_name>
        <contact_address>Tarbiat Modares University, Nasr Bridge, Jalal-Ale-Ahmad Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
