<?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>IRCT20130416013027N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-23</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>The survey of transcranial direct current stimulation efficacy on the post-traumatic sleep quality, insomnia severity in the patients with mild traumatic brain injury during sub-acute phase</public_title>
      <acronym>tDCS-TBI</acronym>
      <scientific_title>The survey of transcranial direct current stimulation efficacy on the post-traumatic sleep quality, insomnia severity in the patients with mild traumatic brain injury during sub-acute phase</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37827</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples by are divided into two intervention groups by sealed envelope software using random blocks method including Four blocks. Each group includes 32 people. 1- A group receiving true tDCS 2- A group that receives tDCS plus medicine. The intervener randomly chooses a block and applies the assignment of the sample to the groups based on that block, Blinding description: During blinding, an individual other than the patient's examiner sets the device for triggering or not, so the examiner and the patient are not known to be in the tDCS group or the sham.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Insomnia in subacute traumatic brain injury.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:32 patients. The group receiving the actual tDCS. Anodal tDCS is performed on the right DLPFC and cathodal on the left shoulder with a 1.5 mA excitation intensity and a 15-min excitation duration over 15 weekly sessions of 5 consecutive sessions for three weeks. Intervention 2: Control group:Includes 32 patients receiving sham tDCS with medication. In the control group, 30 seconds of electrical stimulation is applied and then discontinued. But they receive drug treatment.</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:
Some information related to main outcome are provided

When:
6 months after summary data published

To whom:
Only academic researchers

Conditions:
For the therapeutic decision making in clinic

Where to obtain:
s.ramezanislp@gmail.com

How to obtain:
Between 1 to 2 month after request

Comments:
I have no comment</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohair Reihanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parastar Ave-PourSina Hospital-Trauma research center</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193713194</zip>
        <telephone>+98 13 3336 8773</telephone>
        <email>zoheir.reihanian@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Ramezani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parastar Ave-PourSina Hospital-Trauma Research Center</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193713194</zip>
        <telephone>+98 13 3336 8773</telephone>
        <email>s.ramezanislp@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients aged 18 to 65 years
Normal and abnormal findings on brain scans within the first 24 hours of hospitalization
all TBI severity
at least 2 weeks to one month after the time of injury onset
The ISI score is over 7 .</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People with a history of primary sleep disorders
taking psychotropic drugs one month before entering the study
having serious neurological and psychiatric disorders
patients with previous traumas
those with tDCS contraception, such as pregnant patients, patients with metal implants or pains, those having a heart pacemaker, taking a psychoactive drug or an effective CNS drug, substance abusers, existence of psychiatric and neurological diseases , a history of seizure, epilepsy, tumor, Neurotrauma, stroke, or neurological diseases, those experiencing skin eczema under the tDCS electrodes
Clinical instability or having behavioral problems that prevent the cooperation of the subject in the intervention
The use of sodium and calcium-dependent calcium channel blockers such as phenytoin, carbamazepine, verapamil, nimesadine, and flonarazine
having a serious complication associated with tDCS
The patient's dissatisfaction with the continuation of the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S06</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Intracranial injury</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:32 patients. The group receiving the actual tDCS. Anodal tDCS is performed on the right DLPFC and cathodal on the left shoulder with a 1.5 mA excitation intensity and a 15-min excitation duration over 15 weekly sessions of 5 consecutive sessions for three weeks.</i_keyword>
      <i_keyword>Control group:Includes 32 patients receiving sham tDCS with medication. In the control group, 30 seconds of electrical stimulation is applied and then discontinued. But they receive drug treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The severity of insomnia disorder in patients with traumatic brain injury in subacute phase The score on the Insomnia Disorder Intensity Index (ISI) ranged from 0 to 28. Timepoint: Before starting study and one to three months after starting study. Method of measurement: ISI(Insomnia severty index).</prim_outcome>
      <prim_outcome>Sleep quality in patients with traumatic brain injury in subacute phase with a total score on the Pittsburgh Sleep Quality Index (PQQI) score between 0 and 21. Timepoint: Before starting study and one to three months after starting study. Method of measurement: PSQI(Pittsburg sleep quality index).</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-17</approval_date>
        <contact_name>Guilan University of Medical Sciences</contact_name>
        <contact_address>namjoo ave-poursina hospital-way trauma research center Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
