<?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>IRCT20200212046473N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-13</date_registration>
      <primary_sponsor>Tarbiat Modares University</primary_sponsor>
      <public_title>Emotion recognition using forehead biopotentials and physiological signals</public_title>
      <acronym></acronym>
      <scientific_title>Design and implement of emotion recognition system based on dynamic adaptive fusion of forehead biopotentials and physiological signals</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-02-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48313</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Healthy individuals. Condition 2: Emotional states. Condition 3: Forehead biopotentials. Condition 4: Physiological signals.</hc_freetext>
      <i_freetext>Intervention group: 25 healthy males. In one session: 1. Recording forehead biopotentials and physiological signals at eyes-closed and eyes-open rest, 2. Displaying emotional videos to participants to induce six basic emotions (Happiness, Sadness, Anger, Fear, Surprise, Disgust), while recording forehead biopotentials and physiological signals.  A neutral video will be displayed before each emotional video. The device FlexComp Infiniti (Thought Technology Ltd, Montreal, QC), along with the golden electrodes, will be used to record forehead biopotentials. Skin Conductance (SC) and Blood Volume Pulse (BVP) sensors placed on the participant's fingers will be used to record physiological signals..</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>No. 15, Heyat St., Eshraghi Alley, North Karegar Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411893171</zip>
        <telephone>+98 21 6691 9131</telephone>
        <email>z.khodakarami@gmail.com</email>
        <affiliation>Modares Science and Technology Park</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 23 to 32 years
Healthy individuals
Normal or corrected-to-normal vision
University student</inclusion_criteria>
      <agemin>23 years</agemin>
      <agemax>32 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>History of neurological diseases (e.g. migraine or epilepsy)
Medication use</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 25 healthy males. In one session: 1. Recording forehead biopotentials and physiological signals at eyes-closed and eyes-open rest, 2. Displaying emotional videos to participants to induce six basic emotions (Happiness, Sadness, Anger, Fear, Surprise, Disgust), while recording forehead biopotentials and physiological signals.  A neutral video will be displayed before each emotional video. The device FlexComp Infiniti (Thought Technology Ltd, Montreal, QC), along with the golden electrodes, will be used to record forehead biopotentials. Skin Conductance (SC) and Blood Volume Pulse (BVP) sensors placed on the participant's fingers will be used to record physiological signals.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Forehead biopotential signals (contain electrical activities of the brain, heart, facial muscles and eye movements). Timepoint: Before the intervention at the beginning of the session, While displaying the neutral videos, While displaying the emotional videos. Method of measurement: Recording forehead biopotential signals using golden electrodes.</prim_outcome>
      <prim_outcome>Physiological signals. Timepoint: Before the intervention at the beginning of the session, While displaying the neutral videos, While displaying the emotional videos. Method of measurement: Measuring the physiological signals of Skin Conductance (SC), Blood Volume Pulse (BVP) and Interbeat Interval (IBI).</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>Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-02-16</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>
