<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03749538</url>
  </required_header>
  <id_info>
    <org_study_id>MYO-HCFMUSP-06</org_study_id>
    <nct_id>NCT03749538</nct_id>
  </id_info>
  <brief_title>Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies</brief_title>
  <official_title>Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Systemic autoimmune myopathies are a heterogeneous group of rheumatic diseases that primarily&#xD;
      affect the skeletal muscles. The transcranial direct current stimulation technique has been&#xD;
      frequent, for example, in patients with ischemic stroke or for the optimization of muscular&#xD;
      performance in athletes. However, to date, there are no studies evaluating this technique in&#xD;
      patients with systemic autoimmune myopathies. Therefore, the main objective of the present&#xD;
      prospective, randomized, double-blind, placebo-controlled study is to evaluate the safety and&#xD;
      efficacy of the application of acute transcranial current stimulation session in patients&#xD;
      with systemic autoimmune myopathies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, there are no studies evaluating the transcranial current stimulation technique in&#xD;
      patients with systemic autoimmune myopathies. Therefore, the main objective of the present&#xD;
      prospective, randomized, double-blind, placebo-controlled study is to evaluate the safety and&#xD;
      efficacy of the application of acute transcranial direct current stimulation session in&#xD;
      patients with systemic autoimmune myopathies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">May 16, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 16, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Prospective, randomized, double-blind, placebo-controlled study with application or not of a transcranial current stimulation session in patients with systemic autoimmune myopathies.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Double-blind study to transcranial current stimulation</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of treatment-emergent adverse events [safety and tolerability]</measure>
    <time_frame>After 30 minutes of transcranial stimulation.</time_frame>
    <description>Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of treatment-emergent adverse events [safety and tolerability]</measure>
    <time_frame>After 8 weeks of transcranial stimulation.</time_frame>
    <description>Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT)</measure>
    <time_frame>3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation.</time_frame>
    <description>This partially validated tool measures the degree of disease activity of extra-muscular organ systems and muscle. The questionnaire is a series of physician's assessments of disease activity. Score ranges: 0 (best) - 60 (worst).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum levels of Muscle enzymes</measure>
    <time_frame>4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.</time_frame>
    <description>This partially validated tool measures the serum activities of at least 2 of the 4 muscle-associated enzymes including creatine phosphokinase (CK), the transaminases (ALT, AST), lactate dehydrogenase (LD) and aldolase. The reference range value of each muscle enzyme will depend on the laboratory anaysis (kits). International Unit: U/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Assessment Questionnaire (HAQ)</measure>
    <time_frame>3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation</time_frame>
    <description>Especific questionnaire (health assessment questionnaire). Pontuaction 0.00 (best) - 3.00 (worst)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manual Muscle Testing (MMT)</measure>
    <time_frame>4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.</time_frame>
    <description>This partially validated tool assesses muscle strength using manual muscle testing (MMT). A 0 - 10 point scale is proposed for use. An abbreviated group of 8 proximal, distal, and axial muscles performs similarly to a total of 24 muscle groups, and is also proposed for use for research studies. Pontuaction: 0 (worst) - 80 (best)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Activity</measure>
    <time_frame>4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.</time_frame>
    <description>This partially validated tool measures the global evaluation by the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale. Pontuaction: 0 (best) - 10 (worst)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Global Activity</measure>
    <time_frame>4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.</time_frame>
    <description>This partially validated tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm. visual analogue scale. Pontuaction: 0 (best) - 10 (worst)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Myopathy</condition>
  <condition>Neurologic Manifestations</condition>
  <condition>ElectroPhys: Myopathy</condition>
  <arm_group>
    <arm_group_label>Transcranial direct current stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcranial direct current stimulation session: the energy of the anode (transcranial current stimulation) will have as its source a battery-powered DC generator and will be exerted by two electrodes measuring 5x7cm and attached to the head. The electrodes will be located of the primary motor cortex. The electrode with positive charge (anode) will be positioned at contralateral to the dominant limb and the negative charged electrode will be positioned in the supraorbital region ipsilateral to the dominant limb. The active current of direct transcranial stimulation will be applied with the intensity of electric current of 2mA and density of 0.057 mA/cm2 with duration of 20 minutes. During the session, patients will remain seated. Number of sessions: three times, once per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group will not receive a transcranial direct current stimulation session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transcranial direct current stimulation session.</intervention_name>
    <description>Patients with systemic autoimmune myopathies will receive or not acute transcranial direct current stimulation session.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Transcranial direct current stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Classification criteria - EULAR/ACR 2017&#xD;
&#xD;
          -  Classification critera - Connors et al.&#xD;
&#xD;
          -  Objective muscle limb weakness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neoplasia&#xD;
&#xD;
          -  Using heart pacemarker&#xD;
&#xD;
          -  Using visceral metalic clips&#xD;
&#xD;
          -  Infections (HIV, HTLV-1, Hepatitis, etc)&#xD;
&#xD;
          -  Pregnance&#xD;
&#xD;
          -  Previous historical of convulsions or epilepsies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Participant eligibility is based on self-representation of gender identity</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samuel K Shinjo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade de Sao Paulo - Rheumatology Division</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Samuel K Shinjo</last_name>
    <phone>1130617176</phone>
    <email>samuel.shinjo@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sao Paulo University</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Samuel K Shinjo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01246903</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samuel K Shinjo</last_name>
      <phone>1130617176</phone>
      <email>samuel.shinjo@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>May 16, 2023</last_update_submitted>
  <last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Samuel Katsuyuki Shinjo, PhD</investigator_full_name>
    <investigator_title>Professor, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Diseases</mesh_term>
    <mesh_term>Neurologic Manifestations</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03749538
org study id: MYO-HCFMUSP-06
nct id: NCT03749538
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Systemic autoimmune myopathies are a heterogeneous group of rheumatic diseases that primarily
      affect the skeletal muscles. The transcranial direct current stimulation technique has been
      frequent, for example, in patients with ischemic stroke or for the optimization of muscular
      performance in athletes. However, to date, there are no studies evaluating this technique in
      patients with systemic autoimmune myopathies. Therefore, the main objective of the present
      prospective, randomized, double-blind, placebo-controlled study is to evaluate the safety and
      efficacy of the application of acute transcranial current stimulation session in patients
      with systemic autoimmune myopathies.
Currently, there are no studies evaluating the transcranial current stimulation technique in
      patients with systemic autoimmune myopathies. Therefore, the main objective of the present
      prospective, randomized, double-blind, placebo-controlled study is to evaluate the safety and
      efficacy of the application of acute transcranial direct current stimulation session in
      patients with systemic autoimmune myopathies.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, randomized, double-blind, placebo-controlled study with application or not of a transcranial current stimulation session in patients with systemic autoimmune myopathies.
primary purpose: Other
masking: Double (Participant, Investigator)
masking description: Double-blind study to transcranial current stimulation
measure: Frequency of treatment-emergent adverse events [safety and tolerability]
time frame: After 30 minutes of transcranial stimulation.
description: Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
measure: Frequency of treatment-emergent adverse events [safety and tolerability]
time frame: After 8 weeks of transcranial stimulation.
description: Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
measure: Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT)
time frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation.
description: This partially validated tool measures the degree of disease activity of extra-muscular organ systems and muscle. The questionnaire is a series of physician's assessments of disease activity. Score ranges: 0 (best) - 60 (worst).
measure: Serum levels of Muscle enzymes
time frame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
description: This partially validated tool measures the serum activities of at least 2 of the 4 muscle-associated enzymes including creatine phosphokinase (CK), the transaminases (ALT, AST), lactate dehydrogenase (LD) and aldolase. The reference range value of each muscle enzyme will depend on the laboratory anaysis (kits). International Unit: U/L.
measure: Health Assessment Questionnaire (HAQ)
time frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation
description: Especific questionnaire (health assessment questionnaire). Pontuaction 0.00 (best) - 3.00 (worst)
measure: Manual Muscle Testing (MMT)
time frame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
description: This partially validated tool assesses muscle strength using manual muscle testing (MMT). A 0 - 10 point scale is proposed for use. An abbreviated group of 8 proximal, distal, and axial muscles performs similarly to a total of 24 muscle groups, and is also proposed for use for research studies. Pontuaction: 0 (worst) - 80 (best)
measure: Patient Global Activity
time frame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
description: This partially validated tool measures the global evaluation by the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale. Pontuaction: 0 (best) - 10 (worst)
measure: Physician Global Activity
time frame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
description: This partially validated tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm. visual analogue scale. Pontuaction: 0 (best) - 10 (worst)
arm group label: Transcranial direct current stimulation
arm group type: Experimental
description: Transcranial direct current stimulation session: the energy of the anode (transcranial current stimulation) will have as its source a battery-powered DC generator and will be exerted by two electrodes measuring 5x7cm and attached to the head. The electrodes will be located of the primary motor cortex. The electrode with positive charge (anode) will be positioned at contralateral to the dominant limb and the negative charged electrode will be positioned in the supraorbital region ipsilateral to the dominant limb. The active current of direct transcranial stimulation will be applied with the intensity of electric current of 2mA and density of 0.057 mA/cm2 with duration of 20 minutes. During the session, patients will remain seated. Number of sessions: three times, once per day.
arm group label: Placebo
arm group type: Placebo Comparator
description: This group will not receive a transcranial direct current stimulation session.
intervention type: Other
intervention name: Transcranial direct current stimulation session.
description: Patients with systemic autoimmune myopathies will receive or not acute transcranial direct current stimulation session.
arm group label: Placebo
arm group label: Transcranial direct current stimulation
criteria: 
gender: All
gender based: Yes
gender description: Participant eligibility is based on self-representation of gender identity
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Samuel K Shinjo
role: Principal Investigator
affiliation: Universidade de Sao Paulo - Rheumatology Division
last name: Samuel K Shinjo
phone: 1130617176
email: samuel.shinjo@gmail.com
last name: Sao Paulo University
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Samuel Katsuyuki Shinjo, PhD
investigator title: Professor, PhD
mesh term: Muscular Diseases
mesh term: Neurologic Manifestations