<?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>IRCT20220618055211N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-24</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 Parkinson</public_title>
      <acronym>tDCS</acronym>
      <scientific_title>The effects of transcranial direct current stimulation (tDCS) on attention, working memory , response inhibition and reaction time in patients with Parkinson's disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64288</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, two groups will be examined. A group called the intervention group will receive  transcranial direct current stimulation (tDCS) with cognitive rehabilitation training and second group called control  group will receive cognitive rehabilitation training without any stimulation, Randomization description: After selecting all samples to create a random sequence a statistical software (SAS) will be used. To consider the effect of gender, the random block method will be used in random sequence. central random method will be used  to hide random sequence , as the random sequence will be at the disposal of the relevant centers and the researcher  communicating with the relevant center on the basis of the arrival of the participants and ask about the random allocation, Blinding description: The study will be single blind and the estimator will be different from the researcher. the researcher will be unaware of the grouping and outcome of primary and secondary assessments. Since the interventions of the control group and intervention group are different, the blinding of participants is impossible.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Parkinson's disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cognitive rehabilitation program in addition to Transcranial direct current stimulation (tDCS) (20 minute 2  milliampere current applied through the anode electrode on the scalp of the prefrontal dorsolateral region and the cathode electrode on the right supra orbital region) 3 times a week for 3 weeks. the duration of each session will be 45 minutes. Intervention 2: Control group: Cognitive rehabilitation program without any  Transcranial direct current stimulation (tDCS)  3 times a week for 3 weeks. 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 clinics, 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:
Elahe Saeidi Email: ot.saeidi@gmail.com
Address: No.179,Yas Ave., Farvardin Blvd., Baharestan Town, Isfahan
phone :09134253249
Hojjatullah Haghgoo Email: h.haghgoo@yahoo.com 
Address: Department of Occupational therapy, University of Rehabilitation and Social health, Koodakyar 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 and Social health 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>Elahe Saeidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.179,Yas Ave., Farvardin Blvd., Baharestan Town</address>
        <city>Baharestan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8145117269</zip>
        <telephone>+98 31 3682 0256</telephone>
        <email>el.saeidi@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elahe Saeidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.179,Yas Ave., Farvardin Blvd., Baharestan Town</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8145117269</zip>
        <telephone>+98 31 3682 0256</telephone>
        <email>el.saeidi@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>Have a definitive diagnosis of Parkinson by specialist doctor
Fill the consent form
Age between 50-70
Mild cognitive disorder (Montreal Cognitive Assessment (MOCA) score between 20-26)</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Don't complete the intervention or assessment
Change in medicines or any change in medical intervention.
Getting worse in symptoms.
Having skin problems on scalp.
patient with dementia
patient with Parkinson due to substance abuse.
patient with sleep disorders.
patient with depression.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Parkinson's disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Cognitive rehabilitation program in addition to Transcranial direct current stimulation (tDCS) (20 minute 2  milliampere current applied through the anode electrode on the scalp of the prefrontal dorsolateral region and the cathode electrode on the right supra orbital region) 3 times a week for 3 weeks. the duration of each session will be 45 minutes.</i_keyword>
      <i_keyword>Control group: Cognitive rehabilitation program without any  Transcranial direct current stimulation (tDCS)  3 times a week for 3 weeks. the duration of each session will be 45 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score obtained for attention in the Match to Sample Visual Search test. Timepoint: Measurement of attention at the beginning of the study  , after 3 weeks and 1 months after the intervention. Method of measurement: Match to Sample Visual Search test.</prim_outcome>
      <prim_outcome>Score obtained for response inhibition in the Stop Signal Task test. Timepoint: Measurement of response inhibition at the beginning of the study  , after 3 weeks and 1 months after the intervention. Method of measurement: Stop Signal Task 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  , after 3 weeks and 1 months after the intervention. Method of measurement: Spatial Span test.</prim_outcome>
      <prim_outcome>Score obtained for reaction time in the Reaction time test. Timepoint: Measurement of reaction time at the beginning of the study  , after 3 weeks and 1 months after the intervention. Method of measurement: Reaction time 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>2022-06-16</approval_date>
        <contact_name>Ethics committee of Universiti of Social Welfare and Rehabilitation</contact_name>
        <contact_address>Univercity of Rehabilitation Science and Social health, Koodakiar 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>
