<?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>IRCT20161212031362N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-12</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of Non-invasive Peripheral Nerve Stimulation in Action Tremor (Device Clinical Test)</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Non-invasive Median and Radial Nerve Stimulation in tremor alleviating in Patients with Action Tremor: A double-arm, randomized, double-blind clinical trial (Device Clinical Test)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65403</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Block (ُSample Size: 84 (21 Blocks) 
Randomization Unit: Individual
Random sequence by Rand Excel; Website: https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: The wristband device is designed with the ability to adjust the electrical stimulation and artificial stimulation, which are named A and B by the researcher. Study participants, outcome assessors, and data analysts are blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with Action Tremor.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Electrical stimulation  of two median and radial nerves with a frequency of 150 Hz, by a wristband device. Intervention 2: Control group: Sham-stimulation of two median and radial nerves with a frequency of 7 Hz, for 15 seconds by a wristband device.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Hossein Harirchian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iranian Center of Neurological Research, Imam Khomeini Hospital, Keshavarz Boulevard</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6694 8899</telephone>
        <email>harirchm@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Hossein Harirchian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fourth Floor, Iranian Center of Neurological Research Building, Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6694 8899</telephone>
        <email>harirchm@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with Action Tremor</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Advanced liver disease
Advanced renal disease
Patients with Implemented electrical medical device such as: pacemaker, defibrillator, Deep brain stimulation
A history of thalotomy
Epileptic disorders
Peripheral neuropathy
Severe addiction to alcohol or caffeine
Platinum in forearm
Skin sores at the site of stimulation
Pregnancy
Receive botulinum treatment for hand tremors during the past six months
Any neurodegenerative diseases
Changing the medication or adding a new medication one month before</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G25.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential tremor</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Electrical stimulation  of two median and radial nerves with a frequency of 150 Hz, by a wristband device</i_keyword>
      <i_keyword>Control group: Sham-stimulation of two median and radial nerves with a frequency of 7 Hz, for 15 seconds by a wristband device</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Essential Tremor Rating Assessment (TETRAS) scale- 6 task Archimedes score. Timepoint: Before electrical stimulation, 15 minutes after stimulation, then at intervals of 30 minutes, 60 minutes, 90 minutes, 120 minutes after electrical stimulation. Method of measurement: The Essential Tremor Rating Assessment (TETRAS) and score calculation.</prim_outcome>
      <prim_outcome>Bain and Findley activities of daily living (BF-ADL) test score. Timepoint: Before electrical stimulation, 15 minutes after stimulation, then at intervals of 30 minutes, 60 minutes, 90 minutes, 120 minutes after electrical stimulation. Method of measurement: Bain and Findley activities of daily living (BF-ADL) questionnaire and score calculation.</prim_outcome>
      <prim_outcome>Patient's report of improvement by Clinical global impressions  (CGI-I) questionnaire. Timepoint: Before electrical stimulation, 15 minutes after stimulation, then at intervals of 30 minutes, 60 minutes, 90 minutes, 120 minutes after electrical stimulation. Method of measurement: Clinical global impressions questionnaire and score calculation.</prim_outcome>
      <prim_outcome>Tremor power (Frequency). Timepoint: Before electrical stimulation, 15 minutes after stimulation, then at intervals of 30 minutes, 60 minutes, 90 minutes, 120 minutes after electrical stimulation. Method of measurement: ٍElectrical Stimulation Wristband device.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-04</approval_date>
        <contact_name>Ethic Committee of Neuroscience Institute , Tehran University of Medical Sciences</contact_name>
        <contact_address>Neuroscience Institute, Imam Khomeini Hospital complex; Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
