<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/NCT02242162</url>
  </required_header>
  <id_info>
    <org_study_id>2009-A00630-57</org_study_id>
    <nct_id>NCT02242162</nct_id>
  </id_info>
  <brief_title>Establishment of a Non-invasive and Indirect Measure of Volitional Pimax</brief_title>
  <acronym>PI MAX STIM</acronym>
  <official_title>Establishment of a Non-invasive and Indirect Measure of Volitional Pimax</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre d'Investigation Clinique et Technologique 805</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre d'Investigation Clinique et Technologique 805</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Respiratory failure is the main death cause in muscular diseases. Non-invasive and volitional&#xD;
      measures of inspiratory muscles strength include the nasal pressure with an occluded nostril&#xD;
      and the maximal inspiratory pressure (PImax).Unfortunately, volitional maneuvers depend of&#xD;
      patient effort. The mean of this reseach is to validate a non-invasive and non-volitional&#xD;
      technique to evaluate diaphragm strength at muscular diseases patients.The methdology consist&#xD;
      to compar PImax measure to nerves magnetical stimulation maneuvers measure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2009</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>magnetic stimulation pressure measure( Pstim)</measure>
    <time_frame>10 minutes</time_frame>
    <description>phrenic nerves magnetic stimulations</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">75</enrollment>
  <condition>Neuromuscular Diseases</condition>
  <condition>Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>neuromuscular diseases</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>phrenic nerves magnetic stimulations</intervention_name>
    <arm_group_label>neuromuscular diseases</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        neuromuscular diseases&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neuromuscular disease&#xD;
&#xD;
          -  Pimax evaluation indication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  usual contre-indications for nuclear magnetic resonance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>frederic Lofaso, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital R Poincaré</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital R Poincaré</name>
      <address>
        <city>Garches</city>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>March 1, 2016</last_update_submitted>
  <last_update_submitted_qc>March 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>phrenic nerves magnetic stimulations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Neuromuscular Diseases</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/NCT02242162
org study id: 2009-A00630-57
nct id: NCT02242162
lead sponsor: 
has dmc: Yes
Respiratory failure is the main death cause in muscular diseases. Non-invasive and volitional
      measures of inspiratory muscles strength include the nasal pressure with an occluded nostril
      and the maximal inspiratory pressure (PImax).Unfortunately, volitional maneuvers depend of
      patient effort. The mean of this reseach is to validate a non-invasive and non-volitional
      technique to evaluate diaphragm strength at muscular diseases patients.The methdology consist
      to compar PImax measure to nerves magnetical stimulation maneuvers measure.
observational model: Case-Control
time perspective: Prospective
measure: magnetic stimulation pressure measure( Pstim)
time frame: 10 minutes
description: phrenic nerves magnetic stimulations
arm group label: neuromuscular diseases
intervention type: Procedure
intervention name: phrenic nerves magnetic stimulations
arm group label: neuromuscular diseases
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: No
last name: frederic Lofaso, Pr
role: Principal Investigator
affiliation: Hopital R Poincaré
facility: 
country: France
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
mesh term: Neuromuscular Diseases