<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/NCT03270163</url>
  </required_header>
  <id_info>
    <org_study_id>1708055</org_study_id>
    <secondary_id>2017-A00919-44</secondary_id>
    <nct_id>NCT03270163</nct_id>
  </id_info>
  <brief_title>Evaluation of Muscle Strength by Transcutaneous Electrical Stimulation</brief_title>
  <acronym>STRENGTH-ICU</acronym>
  <official_title>Evaluation of Muscle Strength by Transcutaneous Electrical Stimulation in Intensive Care Unit Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laboratoire de Physiologie de l'Exercice</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</source>
  <oversight_info>
    <has_dmc>No</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>
      Acquired Neuromyopathy of Resuscitation (NMAR) is a common condition. Its diagnosis is&#xD;
      difficult and often late because it is based on a clinical assessment of muscle strength (MRC&#xD;
      score) requiring the patient to be awake and cooperative.&#xD;
&#xD;
      Transcutaneous electrical stimulation consists of applying electrical stimulation along the&#xD;
      path of a motor nerve in order to generate contraction of the previously relaxed muscle. The&#xD;
      mechanical response thus generated is recorded and allows the muscular strength developed to&#xD;
      be assessed. Non-invasive and easily performed in the patient's bed, transcutaneous&#xD;
      electrical stimulation could be an interesting alternative for early assessment of muscle&#xD;
      strength in the still sedated resuscitation patient. However, this technique could be&#xD;
      perceived as uncomfortable or painful in the awake patient so that magnetic stimulation,&#xD;
      which is generally much better tolerated, should be preferred. However, magnetic stimulators&#xD;
      have a limited maximum magnetic field which may prevent supramaximal stimulation especially&#xD;
      in patients developing generalized edema (i.e., in the initial resuscitation phase).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We propose to conduct a reproducibility study of quadriceps force measurement in patients&#xD;
      undergoing resuscitation by transcutaneous electrical and/or magnetic neurostimulation in the&#xD;
      initial (i.e., &lt; 96 h) and late (&gt; 96 h) phases of resuscitation and then in the recovery&#xD;
      phase. For each investigative technique (i.e., electrical vs. magnetic), we will perform 2&#xD;
      types of stimulation: single stimulation and high frequency doublet stimulation (100 Hz),&#xD;
      repeated 3 times each.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 10, 2021</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reproductibility</measure>
    <time_frame>At day 2</time_frame>
    <description>Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reproductibility</measure>
    <time_frame>At day 4</time_frame>
    <description>Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproductibility</measure>
    <time_frame>when the patient wakes up (on average 15 days)</time_frame>
    <description>Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproductibility</measure>
    <time_frame>At day 2</time_frame>
    <description>Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproductibility</measure>
    <time_frame>At day 4</time_frame>
    <description>Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproductibility</measure>
    <time_frame>when the patient wakes up (on average 15 days)</time_frame>
    <description>Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproductibility</measure>
    <time_frame>At day 2</time_frame>
    <description>Reproductibility of the force measurement after one simple electrical muscle stimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproductibility</measure>
    <time_frame>At day 4</time_frame>
    <description>Reproductibility of the force measurement after one simple electrical muscle stimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproductibility</measure>
    <time_frame>when the patient wakes up (on average 15 days)</time_frame>
    <description>Reproductibility of the force measurement after one simple electrical muscle stimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproductibility</measure>
    <time_frame>At day 2</time_frame>
    <description>Reproductibility of the force measurement after one simple magnetic muscle stimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproductibility</measure>
    <time_frame>At day 4</time_frame>
    <description>Reproductibility of the force measurement after one simple magnetic muscle stimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproductibility</measure>
    <time_frame>At day 6</time_frame>
    <description>Reproductibility of the force measurement after one simple magnetic muscle stimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive care unit acquired muscle weakness (ICUAW)</measure>
    <time_frame>1 month</time_frame>
    <description>Occurrence of ICUAW defined by a MRC score less than 48</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Muscle Weakness</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Magnetic and Transcutaneous electrical stimulation of quadriceps</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Transcutaneous electrical stimulation</intervention_name>
    <description>The following tests and measurements will be carried out on the patient within 3 days of inclusion and again between the 4th and 6th day after inclusion and upon awakening:&#xD;
three simple electrical stimulations,&#xD;
three electrical doublets at the frequency of 100Hz&#xD;
For each type of electrical stimulation, the stimulations will be carried out 3 times and reproduced at 1 hour intervals.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Magnetic stimulation</intervention_name>
    <description>The following tests and measurements will be carried out on the patient within 3 days of inclusion and again between the 4th and 6th day after inclusion and upon awakening:&#xD;
three simple magnetic stimulations,&#xD;
three magnetic doublets at the frequency of 100Hz&#xD;
For each type of magnetic stimulation, the stimulations will be carried out 3 times and reproduced at 1 hour intervals.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ultrasound measurement</intervention_name>
    <description>The ultrasound measurement of the thickness of the quadriceps muscle will be carried out on the patient within 3 days of inclusion and again between the 4th and 6th day after inclusion and upon awakening.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  admitted in intensive care unit B of ST-Etienne hospital&#xD;
&#xD;
          -  Predictable duration of mechanical ventilation of more than 72 hours&#xD;
&#xD;
          -  Patient whose family has given informed and written consent to the patient's&#xD;
             participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman,&#xD;
&#xD;
          -  Patients with peripheral nerve damage prior to or at the time of measurement&#xD;
&#xD;
          -  Curarized patients (non-efficacy of neurostimulation)&#xD;
&#xD;
          -  Fracture of limb or pelvis&#xD;
&#xD;
          -  Presence of a catheter in the stimulation zone (femoral artery or vein)&#xD;
&#xD;
          -  Patients suffering from psychiatric pathologies.&#xD;
&#xD;
          -  Brain pathology leading the patient to intensive care.&#xD;
&#xD;
          -  Patients with neuromuscular pathology.&#xD;
&#xD;
          -  Patients carrying equipment subject to possible electrical and/or magnetic&#xD;
             interference,&#xD;
&#xD;
          -  Patient with spinal fracture(s) at risk of spinal cord injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jérôme MOREL, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jérôme MOREL, MD</last_name>
    <phone>0477828553</phone>
    <phone_ext>33</phone_ext>
    <email>jerome.morel@chu-st-etienne.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Béatrice DEYGAS, CRA</last_name>
    <email>beatrice.deygas@chu-st-etienne.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chu Saint-Etienne</name>
      <address>
        <city>Saint-etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jérôme MOREL, MD</last_name>
      <email>jerome.morel@chu-st-etienne.fr</email>
    </contact>
    <investigator>
      <last_name>Jérôme MOREL</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laetitia BURNOL</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean Baptiste BOUCHET</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>April 24, 2023</last_update_submitted>
  <last_update_submitted_qc>April 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intensive care unit acquired muscle weakness</keyword>
  <keyword>Transcutaneous electrical stimulation</keyword>
  <keyword>magnetic stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</mesh_term>
    <mesh_term>Paresis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03270163
org study id: 1708055
secondary id: 2017-A00919-44
nct id: NCT03270163
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acquired Neuromyopathy of Resuscitation (NMAR) is a common condition. Its diagnosis is
      difficult and often late because it is based on a clinical assessment of muscle strength (MRC
      score) requiring the patient to be awake and cooperative.

      Transcutaneous electrical stimulation consists of applying electrical stimulation along the
      path of a motor nerve in order to generate contraction of the previously relaxed muscle. The
      mechanical response thus generated is recorded and allows the muscular strength developed to
      be assessed. Non-invasive and easily performed in the patient's bed, transcutaneous
      electrical stimulation could be an interesting alternative for early assessment of muscle
      strength in the still sedated resuscitation patient. However, this technique could be
      perceived as uncomfortable or painful in the awake patient so that magnetic stimulation,
      which is generally much better tolerated, should be preferred. However, magnetic stimulators
      have a limited maximum magnetic field which may prevent supramaximal stimulation especially
      in patients developing generalized edema (i.e., in the initial resuscitation phase).
We propose to conduct a reproducibility study of quadriceps force measurement in patients
      undergoing resuscitation by transcutaneous electrical and/or magnetic neurostimulation in the
      initial (i.e., < 96 h) and late (> 96 h) phases of resuscitation and then in the recovery
      phase. For each investigative technique (i.e., electrical vs. magnetic), we will perform 2
      types of stimulation: single stimulation and high frequency doublet stimulation (100 Hz),
      repeated 3 times each.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Reproductibility
time frame: At day 2
description: Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.
measure: Reproductibility
time frame: At day 4
description: Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.
measure: Reproductibility
time frame: when the patient wakes up (on average 15 days)
description: Reproductibility of the force measurement after electrical muscle stimulation by a doublet at 100 Hz.
measure: Reproductibility
time frame: At day 2
description: Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.
measure: Reproductibility
time frame: At day 4
description: Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.
measure: Reproductibility
time frame: when the patient wakes up (on average 15 days)
description: Reproductibility of the force measurement after magnetic muscle stimulation by a doublet at 100 Hz.
measure: Reproductibility
time frame: At day 2
description: Reproductibility of the force measurement after one simple electrical muscle stimulation
measure: Reproductibility
time frame: At day 4
description: Reproductibility of the force measurement after one simple electrical muscle stimulation
measure: Reproductibility
time frame: when the patient wakes up (on average 15 days)
description: Reproductibility of the force measurement after one simple electrical muscle stimulation
measure: Reproductibility
time frame: At day 2
description: Reproductibility of the force measurement after one simple magnetic muscle stimulation
measure: Reproductibility
time frame: At day 4
description: Reproductibility of the force measurement after one simple magnetic muscle stimulation
measure: Reproductibility
time frame: At day 6
description: Reproductibility of the force measurement after one simple magnetic muscle stimulation
measure: Intensive care unit acquired muscle weakness (ICUAW)
time frame: 1 month
description: Occurrence of ICUAW defined by a MRC score less than 48
arm group label: Experimental
arm group type: Experimental
description: Magnetic and Transcutaneous electrical stimulation of quadriceps
intervention type: Diagnostic Test
intervention name: Transcutaneous electrical stimulation
description: The following tests and measurements will be carried out on the patient within 3 days of inclusion and again between the 4th and 6th day after inclusion and upon awakening:
three simple electrical stimulations,
three electrical doublets at the frequency of 100Hz
For each type of electrical stimulation, the stimulations will be carried out 3 times and reproduced at 1 hour intervals.
arm group label: Experimental
intervention type: Diagnostic Test
intervention name: Magnetic stimulation
description: The following tests and measurements will be carried out on the patient within 3 days of inclusion and again between the 4th and 6th day after inclusion and upon awakening:
three simple magnetic stimulations,
three magnetic doublets at the frequency of 100Hz
For each type of magnetic stimulation, the stimulations will be carried out 3 times and reproduced at 1 hour intervals.
arm group label: Experimental
intervention type: Diagnostic Test
intervention name: ultrasound measurement
description: The ultrasound measurement of the thickness of the quadriceps muscle will be carried out on the patient within 3 days of inclusion and again between the 4th and 6th day after inclusion and upon awakening.
arm group label: Experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jérôme MOREL, MD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
last name: Jérôme MOREL, MD
phone: 0477828553
phone ext: 33
email: jerome.morel@chu-st-etienne.fr
last name: Béatrice DEYGAS, CRA
email: beatrice.deygas@chu-st-etienne.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Muscle Weakness
mesh term: Paresis
sharing ipd: No