<?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>IRCT20240312061271N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-04-02</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>comparative effects of bilateral and unilateral transcranial direct current stimulation (tDCS) over the motor cortex on motor learning in healthy older adults</public_title>
      <acronym></acronym>
      <scientific_title>comparative effects of bilateral and unilateral transcranial direct current stimulation (tDCS) over the motor cortex on motor learning in healthy older adults</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75987</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this study, a simple and easily accessible sampling method will be used. Individuals will be divided into three groups completely at random. To ensure randomization, the block method will be used along with random tables to select numbers between 1 and 6. A treatment allocation list will then be created based on each number. Boxes will be numbered in a random sequence and each box will contain either the desired intervention or a sheet with random allocation written on it. These boxes will be completely sealed and given to the administrator and researcher based on the order of arrival of the patients. Using the aforementioned items, the standard intervention and treatment group for each person will be determined, Blinding description: To minimize bias in the study, all treatment steps will be performed by the main researcher, while the evaluation steps before and after the intervention will be carried out by a research assistant who is a physiotherapist. Participants in each group will not be informed about the treatment of the other group, and the evaluator will not be aware of which group each participant belongs to.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Motor learning of the healthy young elderly.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: receiving unilateral anodal tDCS. The active anode electrode is placed on the left M1 area of the brain (C3) and the cathode electrode is placed on the right side of the forehead area for 20 minutes with an intensity of 1 mA. Intervention 2: The second intervention group: received bilateral tDCS. The anode electrode is placed on the left M1 area, and the cathode electrode is placed on the right M1 area for 20 minutes with an intensity of 1 mA. Intervention 3: Control group: will receive a simulated electrical stimulation of the motor area of the brain, known as sham tDCS. The placement of the electrodes will be chosen randomly. The current will increase for the first 45 seconds and then remain constant for 60 seconds, before being turned off completely. Similar to the other groups, the electrodes will remain inactive for up to 20 minutes after the procedure.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No additional information available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yaghoubali Shourvarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Sub-section 17, Quds St.</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3515771979</zip>
        <telephone>+98 51 4225 7369</telephone>
        <email>shourvarziy@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Ehsani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neuromuscular Rehabilitation Research Center, Tabatabai Clinic, Quds Boulevard, Mashahir Square</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519618375</zip>
        <telephone>+98 23 3332 8502</telephone>
        <email>fatemehehsani59@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy young elderly people with an age range of 60-75 years.
The dominant hand of the participants should be the right hand.
Willingness to participate in the study and sign the informed consent form.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reporting any history of neurological diseases such as Parkinson's, Alzheimer's, schizophrenia and dyslexia in such a way that the disease has affected the person's ability to learn.
Report any history of psychological illness
Report exposure to currents affecting the central nervous system during the last two weeks
Report on the use of any type of sedative medication during the last two days
Report any symptoms of forgetfulness and depression
Memory disorders with a score of less than 21 through the MMSE test
The presence of any symptoms of movement disorders in the upper limb of the right hand, which, according to the researcher's evaluation and diagnosis, has caused movement restrictions in the joints of the upper limb.
Observing any symptoms of radiculopathy and carpal tunnel syndrome in the right hand with the researcher's diagnosis
Report uncorrected vision and hearing impairments
Report dizziness
Pacemaker users
Contraindications to the use of electrical stimulation
Inability to understand or follow the study process
Reluctance to participate in the study</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>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: receiving unilateral anodal tDCS. The active anode electrode is placed on the left M1 area of the brain (C3) and the cathode electrode is placed on the right side of the forehead area for 20 minutes with an intensity of 1 mA.</i_keyword>
      <i_keyword>The second intervention group: received bilateral tDCS. The anode electrode is placed on the left M1 area, and the cathode electrode is placed on the right M1 area for 20 minutes with an intensity of 1 mA.</i_keyword>
      <i_keyword>Control group: will receive a simulated electrical stimulation of the motor area of the brain, known as sham tDCS. The placement of the electrodes will be chosen randomly. The current will increase for the first 45 seconds and then remain constant for 60 seconds, before being turned off completely. Similar to the other groups, the electrodes will remain inactive for up to 20 minutes after the procedure.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of errors. Timepoint: Before, immediately after, and 72 hours post tDCS application. Method of measurement: Color matching test software.</prim_outcome>
      <prim_outcome>Reaction time. Timepoint: Before, immediately after, and 72 hours post tDCS application. Method of measurement: Color matching test software.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-03-12</approval_date>
        <contact_name>Ethics Committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Semnan University of Medical Sciences and Health Services Headquarters, Basij Blvd, Semnan Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
