<?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>IRCT20170703034879N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-15</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of rTMS on HSP</public_title>
      <acronym></acronym>
      <scientific_title>Effect of repetitive trans-cranial magnetic stimulation (rTMS) of lower limb motor cortex on Lower extremity spasticity in patients with hereditary spastic paraplegia (HSP): A randomized sham-controlled double-blind study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50562</url>
      <study_type>observational</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: We used computer-generated blocks for randomization. We asked a third party with no role in patient registration or data analysis to generate a number of blocks with 4 spots, 2 for intervention and 2 for sham. When the patient registration started, the person in charge of randomization was asked to start choosing a random block and inform the operator (who was an independent person with no role in patient registration and analysis) of the type of intervention for each patient in order of registration. in total 2 blocks of 4 were used for our 8 patients, Blinding description: For patient's in sham group, we used the same coil in active group but we placed it perpendicular to patient's scalp, therefore we were able to reproduce the somatic vibration sensation and acoustic artifact without stimulating motor cortex. As patients would receive intervention in separate appointments and there was no contact between patients, apart from the operator of rTMS, everyone -including the clinician who evaluated the outcomes and the analyst- was blind to the intervention for each patients.</study_design>
      <phase>3</phase>
      <hc_freetext>Hereditary spastic paraplegia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 5 sessions of 5 Hz rTMS on 5 consecutive days. each session comprised of 5 trains of 60 second duration and 2 minute inter train interval. Intervention 2: Control group: 5 sessions of sham rTMS with same duration as active intervention group with coil placed perpendicular to patient's scalp.</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:
Mentioned information will be made available along with the manuscript as supplementary files.

When:
Same time as the publication of the manuscript

To whom:
All those who have access to the published manuscript.

Conditions:
Those who wish to perform further analysis on the data must submit their written request to the corresponding author of the article.

Where to obtain:
Corresponding author of the published manuscript.

How to obtain:
any request received by corresponding author will be shared with the research team and decision upon the requested permission will be made available to the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Siamak Abdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neurology department, Shariati hospital, Jalal-e-Al-e-Ahmad Hwy</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 8490 2224</telephone>
        <email>Siamak.Abdi@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Siamak Abdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neurology department, Shariati hospital, North Kargar street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۱۱۷۱۳۱۳۵</zip>
        <telephone>+98 21 8490 2224</telephone>
        <email>Siamak.Abdi@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis based on Fink's Criteria
Signed written informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of Seizure
Uncontrolled hypertension
Cochlear implant
Cardiac Pacemaker
Foreign body in patient's body</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G11.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hereditary spastic paraplegia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 5 sessions of 5 Hz rTMS on 5 consecutive days. each session comprised of 5 trains of 60 second duration and 2 minute inter train interval.</i_keyword>
      <i_keyword>Control group: 5 sessions of sham rTMS with same duration as active intervention group with coil placed perpendicular to patient's scalp.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improvement of lower limb spasticity based on modified Ashworth scale. Timepoint: Before intervention, upon completion of 5 sessions of rTMS, 1 moth after intervention. Method of measurement: Modified Ashworth Scale (MAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Change in patients' mobility based on 10-meter walking test. Timepoint: Before intervention, upon completion of 5 sessions of rTMS, 1 month after intervention. Method of measurement: 10-meter Walking test.</sec_outcome>
      <sec_outcome>Change in motor function of lower limb. Timepoint: Before intervention, upon completion of 5 sessions of rTMS, 1 month after intervention. Method of measurement: Fugl-Meyer Assessment of lower limb (FMA-LE).</sec_outcome>
      <sec_outcome>Quality of Life. Timepoint: Before intervention, upon completion of 5 sessions of rTMS, 1 month after intervention. Method of measurement: Short form survey 36 (SF-36).</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>2016-11-22</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>School of Medicine - Poursina street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
