<?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>IRCT20210819052231N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-04</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The effect of transcranial direct current stimulation (tDCS) on cognition in people with MS</public_title>
      <acronym>tDCS, MS</acronym>
      <scientific_title>The effect of transcranial direct current stimulation(tDCS) on attention, working memory and information processing speed in people with MS</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58217</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Other design features: In this study, three groups will be examined. A group called the intervention group will receive the intervention along with tDCS. The control group one will receive intended intervention with sham tDCS. Control group two will only receive the intervention without any stimulation, Randomization description: After selecting all samples for dividing them into groups as intervention experimental, control 1 and control 2 we will use the SAS application and the PROC SURVEYSELECT process, which is for generating a random sequence for experiments with more complex designs, including factorial experiments, Blinding description: Participants, outcome assessors and data analysts will be unaware of how people are grouped.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group first: Cognitive rehabilitation program (including routine rehabilitation exercises in occupational therapy clinics) in addition to tDCS stimulation (20 minutes of two milliampere current applied through the anode electrode on the scalp of the prefrontal dorsultral region and the cathode electrode upper of right eyebrow ) 4 times a week for three weeks. The duration of each session will be 45 minutes. Intervention 2: Intervention group second: The tDCS is used artificially (placing the anode and cathode electrodes on the scalp for 20 minutes, establishing a 2 mA current for 10 seconds, and then cutting off the current for the next 10 seconds) with a cognitive  rehabilitation program. 4 times a week for three weeks and the duration of each session will be 45 minutes. Intervention 3: Control group: Only the cognitive rehabilitation program runs. They will receive 4 times a week for three weeks and the duration of each session will be 45 minutes.</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 data is potentially shareable after unidentifiable individuals

When:
Access period starts 6 months after the results are published

To whom:
All individuals, including researchers working in academic and scientific institutions and those working in the clinic, can apply for the data.

Conditions:
The data will be provided to researchers for further studies or to use this data for related research.

Where to obtain:
Hamideh Aghachavoshi
Email Address: aghachavoshi_hamide@yahoo.com
Address: Unit 4, Block 33/2, Eram Dead End, Besharat St., Hakimieh, Tehran
Phone: 09137729652
Dr. Hojjatullah Haghgoo
Email Address: H.haghgoo@yahoo.com
Address: Department of Occupational Therapy, University of Rehabilitation and Social Health, Koodakiar St., Daneshjoo Blvd., Evin, Tehran
Phone: 02122180063

How to obtain:
Files and documents will be provided to the applicant through correspondence and application to the Department of Occupational Therapy of the University of Rehabilitation Sciences and Social Welfare and the approval of the director and deputy director of the Department of Occupational Therapy.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamide Aghachavoshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kodakyar Ave., Daneshjo Blvd., Evin, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 7730 3532</telephone>
        <email>hm.aghachavoshi@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamide Aghachavoshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kodakyar Ave., Daneshjo Blvd., Evin, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 7730 3532</telephone>
        <email>hm.aghachavoshi@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willing to participate in research
Have a definitive diagnosis of MS by a specialist doctor
EDSS score should be from 1 to 6
The person has no history of dementia and other psychotic illnesses
There is no Recurrence of relapsing while doing the study
Do not take corticosteroids for 28 days before the intervention
Have no history of other neurological diseases</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Do not complete the intervention
Recurrence of relapsing occurs during the intervention</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</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 first: Cognitive rehabilitation program (including routine rehabilitation exercises in occupational therapy clinics) in addition to tDCS stimulation (20 minutes of two milliampere current applied through the anode electrode on the scalp of the prefrontal dorsultral region and the cathode electrode upper of right eyebrow ) 4 times a week for three weeks. The duration of each session will be 45 minutes.</i_keyword>
      <i_keyword>Intervention group second: The tDCS is used artificially (placing the anode and cathode electrodes on the scalp for 20 minutes, establishing a 2 mA current for 10 seconds, and then cutting off the current for the next 10 seconds) with a cognitive  rehabilitation program. 4 times a week for three weeks and the duration of each session will be 45 minutes.</i_keyword>
      <i_keyword>Control group: Only the cognitive rehabilitation program runs. They will receive 4 times a week for three weeks and the duration of each session will be 45 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score obtained for attention in the Paired Associate Learning test. Timepoint: Measurement of attention at the beginning of the study and after three weeks and 2 months after the intervention. Method of measurement: Paired Associate Learning test.</prim_outcome>
      <prim_outcome>Score obtained for working memory in the Spatial Span test. Timepoint: Measurement of working memory at the beginning of the study and after three weeks and 2 months after the intervention. Method of measurement: Spatial Span test.</prim_outcome>
      <prim_outcome>Score obtained for data processing speed in Paced Auditory Serial Addition Test. Timepoint: Measurement of information processing speed at the beginning of the study and after three weeks and 2 months after the intervention. Method of measurement: Paced Auditory Serial Addition 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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-19</approval_date>
        <contact_name>Ethics committee of University of Social Welfare and Rehabilitation</contact_name>
        <contact_address>University of Rehabilitation Sciences and Socia Health, Koodkiar St., Daneshjoo Blvd., Evin, Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
