<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/NCT03751644</url>
  </required_header>
  <id_info>
    <org_study_id>MYO-HCFMUSP-07</org_study_id>
    <nct_id>NCT03751644</nct_id>
  </id_info>
  <brief_title>Peripherical Neuromuscular Electrical Stimulation in Systemic Autoimmune Myopathies</brief_title>
  <official_title>Peripherical Neuromuscular Electrical Stimulation in 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 with&#xD;
      progressive skeletal muscle weakness. The relevance of the peripherical neuromuscular&#xD;
      electrical stimulation has never applied in the patients with systemic autoimmune myopathies.&#xD;
      Therefore, the main objective of the present prospective, randomized, investigator-blind,&#xD;
      placebo-controlled study is to evaluate the safety and efficacy of the application of an&#xD;
      acute peripherical neuromuscular electrical stimulation session in patients with systemic&#xD;
      autoimmune myopathies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Systemic autoimmune myopathies are a heterogeneous group of rheumatic diseases that primarily&#xD;
      affect the skeletal muscles. Despite these advances, this group of diseases still continues&#xD;
      to be associated with high morbidity and functional disability, mainly due to the proximal&#xD;
      muscular weakness of the scapular and pelvic girdles that may prevent the total recovery of&#xD;
      these patients. On the other hand, the importance of the peripherical neuromuscular&#xD;
      electrical stimulation has never applied in the patients with systemic autoimmune myopathies.&#xD;
      Therefore, the main objective of the present prospective, randomized, investigator-blind,&#xD;
      placebo-controlled study is to evaluate the safety and efficacy of the application of an&#xD;
      acute peripherical neuromuscular electrical stimulation session in patients with systemic&#xD;
      autoimmune myopathies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">April 29, 2021</completion_date>
  <primary_completion_date type="Actual">April 29, 2021</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>Patients with systemic autoimmune myopathies will receive or not the periphericalneuromuscular electrical stimulation in thigh muscles</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Patients will be randomized by non-investigator from the present study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of treatment-emergent adverse events [safety and tolerability]</measure>
    <time_frame>30 minutes after stimulation</time_frame>
    <description>Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration) electrical stimulation in patients with systemic autoimmune myopathies.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of treatment-emergent adverse events [safety and tolerability]</measure>
    <time_frame>8 weeks after stimulation</time_frame>
    <description>Frequency of disease relapsing (based on the questionnaire of secondary outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Healthy 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>Specific questionnaires to assess the quality of life. Pontuaction: 0.00 (best) - 3.00 (worst)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient/Parent 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. Pontuaction: 0 (best) - 10 (worst)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manual Muscle Testing</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>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 min before; (b) until 30 min 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. International Unit: U/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength muscle tests</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>The dynamic 1-repetition maximum for the leg-press will be assessed at baseline and after the intervention. Strength unit: Newton (N). The values vary according to each patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength muscle tests</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>The dynamic 1-repetition maximum for the bench-press exercises will be assessed at baseline and after the intervention. Strength unit: Newton (N). The values vary according to each patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength muscle tests</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>Isometric strength (assessed by handgrip, with the dominant arm) will be assessed at baseline and after the intervention. Strength unit: Newton (N). The values vary according to each patient.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Electrical Remodeling</condition>
  <condition>Rheumatic Diseases</condition>
  <condition>Myopathy</condition>
  <arm_group>
    <arm_group_label>Electrical stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After local antisepsis, 4 electrodes will be placed at the proximal and distal extremities of the lateral and vastus medialis muscles of dominant limb. A positive, single-phase pulsating (intermittent) current with a rectangular waveform will be delivered with a duty cycle of 10 to 15 seconds shutdown at a frequency of 60 Hertz with a pulse width of 400 microseconds for 30 minutes. To control the degree of muscle activation, electrical stimulation will be administered at an intensity that will consistently produce a target torque equal to 15% of maximal voluntary contraction, as monitored in real time through torque output. The desired intensity of stimulation and intensity adjustments throughout the treatment will be evaluated in all patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will not submitted to electrical stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electrical stimulation</intervention_name>
    <description>Patients with systemic autoimmune myopathies will receive peripheral electrical stimulation in thigh muscles</description>
    <arm_group_label>Electrical stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Classification criteria - EULAR/ACR 2017&#xD;
&#xD;
          -  Classification criteria - 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;
          -  Pregnancy&#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>
  <location>
    <facility>
      <name>Samuel K Shinjo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01246903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2021</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 23, 2018</study_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</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>
  <keyword>systemic autoimmune myopathies</keyword>
  <keyword>Peripherical neuromuscular electrical stimulation</keyword>
  <keyword>myositis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Muscular Diseases</mesh_term>
    <mesh_term>Collagen Diseases</mesh_term>
    <mesh_term>Atrial Remodeling</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03751644
org study id: MYO-HCFMUSP-07
nct id: NCT03751644
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 with
      progressive skeletal muscle weakness. The relevance of the peripherical neuromuscular
      electrical stimulation has never applied in the patients with systemic autoimmune myopathies.
      Therefore, the main objective of the present prospective, randomized, investigator-blind,
      placebo-controlled study is to evaluate the safety and efficacy of the application of an
      acute peripherical neuromuscular electrical stimulation session in patients with systemic
      autoimmune myopathies.
Systemic autoimmune myopathies are a heterogeneous group of rheumatic diseases that primarily
      affect the skeletal muscles. Despite these advances, this group of diseases still continues
      to be associated with high morbidity and functional disability, mainly due to the proximal
      muscular weakness of the scapular and pelvic girdles that may prevent the total recovery of
      these patients. On the other hand, the importance of the peripherical neuromuscular
      electrical stimulation has never applied in the patients with systemic autoimmune myopathies.
      Therefore, the main objective of the present prospective, randomized, investigator-blind,
      placebo-controlled study is to evaluate the safety and efficacy of the application of an
      acute peripherical neuromuscular electrical stimulation session in patients with systemic
      autoimmune myopathies.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients with systemic autoimmune myopathies will receive or not the periphericalneuromuscular electrical stimulation in thigh muscles
primary purpose: Other
masking: Single (Investigator)
masking description: Patients will be randomized by non-investigator from the present study
measure: Frequency of treatment-emergent adverse events [safety and tolerability]
time frame: 30 minutes after stimulation
description: Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration) electrical stimulation in patients with systemic autoimmune myopathies.
measure: Frequency of treatment-emergent adverse events [safety and tolerability]
time frame: 8 weeks after stimulation
description: Frequency of disease relapsing (based on the questionnaire of secondary outcome
measure: Healthy 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: Specific questionnaires to assess the quality of life. Pontuaction: 0.00 (best) - 3.00 (worst)
measure: Patient/Parent 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. Pontuaction: 0 (best) - 10 (worst)
measure: Manual Muscle Testing
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: 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 min before; (b) until 30 min 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. International Unit: U/L.
measure: Strength muscle tests
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: The dynamic 1-repetition maximum for the leg-press will be assessed at baseline and after the intervention. Strength unit: Newton (N). The values vary according to each patient.
measure: Strength muscle tests
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: The dynamic 1-repetition maximum for the bench-press exercises will be assessed at baseline and after the intervention. Strength unit: Newton (N). The values vary according to each patient.
measure: Strength muscle tests
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: Isometric strength (assessed by handgrip, with the dominant arm) will be assessed at baseline and after the intervention. Strength unit: Newton (N). The values vary according to each patient.
arm group label: Electrical stimulation
arm group type: Experimental
description: After local antisepsis, 4 electrodes will be placed at the proximal and distal extremities of the lateral and vastus medialis muscles of dominant limb. A positive, single-phase pulsating (intermittent) current with a rectangular waveform will be delivered with a duty cycle of 10 to 15 seconds shutdown at a frequency of 60 Hertz with a pulse width of 400 microseconds for 30 minutes. To control the degree of muscle activation, electrical stimulation will be administered at an intensity that will consistently produce a target torque equal to 15% of maximal voluntary contraction, as monitored in real time through torque output. The desired intensity of stimulation and intensity adjustments throughout the treatment will be evaluated in all patients.
arm group label: Placebo
arm group type: No Intervention
description: Patients will not submitted to electrical stimulation.
intervention type: Other
intervention name: Electrical stimulation
description: Patients with systemic autoimmune myopathies will receive peripheral electrical stimulation in thigh muscles
arm group label: Electrical 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
facility: 
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: Rheumatic Diseases
mesh term: Muscular Diseases
mesh term: Collagen Diseases
mesh term: Atrial Remodeling
sharing ipd: Undecided