<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/NCT03807258</url>
  </required_header>
  <id_info>
    <org_study_id>5S_PHYCOM</org_study_id>
    <nct_id>NCT03807258</nct_id>
  </id_info>
  <brief_title>Functional Implication of Corpus Callosum in Voluntary Strength in COPD Patients</brief_title>
  <official_title>Functional Implication of Corpus Callosum in Voluntary Strength in COPD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>5 Santé</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>5 Santé</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>
      Patients with COPD have lower capability of activating their muscles. At the cortical level,&#xD;
      force production is not only controlled by contralateral primary motor cortex but also by&#xD;
      ipsilateral motor cortex. The aim of this study is to determine whether ipsilateral areas are&#xD;
      functionally impaired in COPD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) patients exhibit not only respiratory symptoms&#xD;
      but also a peripheral muscular weakness. This weakness is characterized by a loss in&#xD;
      strength, harmful for the patients' life quality and vital prognosis (Swallow et al., 2007).&#xD;
      Even if many studies have enlightened damages at a peripheral level, the muscular atrophy&#xD;
      itself cannot totally explain the loss in force (Menon et al., 2012). Furthermore, the&#xD;
      contractile properties of COPD muscles fibres are preserved (Debigare et al., 2003).&#xD;
      Consequently, peripheral muscle weakness cannot only be explained by peripheral factors and&#xD;
      central structures must be investigated.&#xD;
&#xD;
      At the central level, it is admitted that force production is controlled by the activation of&#xD;
      contralateral motor areas. In COPD, these areas were found to be less activated than in&#xD;
      controls during force production (Alexandre et al., 2014). However, recent studies bring the&#xD;
      evidence that ipsilateral motor areas are also mobilized to cope demand during such task. The&#xD;
      activation of ipsilateral areas is possible through inter hemispheric pathways, as the corpus&#xD;
      callosum. Recently, the integrity of the corpus callosum have been linked to the capability&#xD;
      of activating the ipsilateral motor cortex (Chiou et al., 2014) during force production. This&#xD;
      is of concern knowing that several studies reported white matter lesions in the brain of COPD&#xD;
      patients (Dodd et al, 2012) and more precisely in regions containing the corpus callosum&#xD;
      (Lahousse et al., 2013).&#xD;
&#xD;
      Therefore, we hypothesize that COPD patients have a lower capability of activating their&#xD;
      ipsilateral motor cortex during force production compared to controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 20, 2018</start_date>
  <completion_date type="Actual">March 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>COPD Patients vs. Controls</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ipsilateral excitability ratio : rest - 50% mvic</measure>
    <time_frame>Baseline</time_frame>
    <description>Ratio of ipsilateral excitability. Measured at rest, and during a 50% max. isometric contraction. Then, ipsilateral excitability ratio = rest / 50% * 100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ipsilateral inhibition ratio : rest - 50% mvic</measure>
    <time_frame>Baseline</time_frame>
    <description>Ratio of ipsilateral inhibition. Measured at rest, and during a 50% max. isometric contraction. Then, ipsilateral inhibition ratio = rest / 50% * 100. SICI (2ms) method is used to quantify inhibition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interhemispheric inhibition</measure>
    <time_frame>Baseline</time_frame>
    <description>Interhemispheric inhibition, from contralateral to ipsilateral motor cortex, using reference method from Ferbert et al., 1992.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship between inter hemispheric inhibition and voluntary strength</measure>
    <time_frame>Baseline</time_frame>
    <description>Correlation coefficient between inter hemispheric inhibition and maximal isometric force production</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>S100B and GFAP</measure>
    <time_frame>Baseline</time_frame>
    <description>Serum concentrations of S100B and GFAP proteins, brain lesions markers</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Neurophysiology</condition>
  <condition>Physiology</condition>
  <arm_group>
    <arm_group_label>COPD patients group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>COPD patients undergoing transcranial magnetic stimulation (TMS) evaluations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy matched controls undergoing transcranial magnetic stimulation (TMS) evaluations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transcranial magnetic stimulation (TMS)</intervention_name>
    <description>Evaluations by TMS</description>
    <arm_group_label>COPD patients group</arm_group_label>
    <arm_group_label>Controls group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Health insurance&#xD;
&#xD;
          -  Patients : COPD Gold II-IV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Seizures&#xD;
&#xD;
          -  Unable to give written consent&#xD;
&#xD;
          -  Metalic object above shoulders&#xD;
&#xD;
          -  Dermatological issue concerning surface electrodes&#xD;
&#xD;
          -  Caffeine consumption &gt; 4 coffee / day&#xD;
&#xD;
          -  Neurological disorders&#xD;
&#xD;
          -  Opioid-based treatment&#xD;
&#xD;
          -  Patients : recent exacerbation (&lt; 4 weeks)&#xD;
&#xD;
          -  Patients : rehabilitation in previous 1 year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicolas Oliver, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>5 Santé</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cliniques du Souffle</name>
      <address>
        <city>Lodeve</city>
        <state>Herault</state>
        <zip>34700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques du Souffle</name>
      <address>
        <city>Osséja</city>
        <state>Pyrenees Orientales</state>
        <zip>66340</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 10, 2020</last_update_submitted>
  <last_update_submitted_qc>January 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Transcranial magnetic stimulation</keyword>
  <keyword>Motor-evoked potentials</keyword>
  <keyword>Muscle weakness</keyword>
  <keyword>Interhemispheric</keyword>
  <keyword>Inhibition</keyword>
  <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/NCT03807258
org study id: 5S_PHYCOM
nct id: NCT03807258
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with COPD have lower capability of activating their muscles. At the cortical level,
      force production is not only controlled by contralateral primary motor cortex but also by
      ipsilateral motor cortex. The aim of this study is to determine whether ipsilateral areas are
      functionally impaired in COPD.
Chronic obstructive pulmonary disease (COPD) patients exhibit not only respiratory symptoms
      but also a peripheral muscular weakness. This weakness is characterized by a loss in
      strength, harmful for the patients' life quality and vital prognosis (Swallow et al., 2007).
      Even if many studies have enlightened damages at a peripheral level, the muscular atrophy
      itself cannot totally explain the loss in force (Menon et al., 2012). Furthermore, the
      contractile properties of COPD muscles fibres are preserved (Debigare et al., 2003).
      Consequently, peripheral muscle weakness cannot only be explained by peripheral factors and
      central structures must be investigated.

      At the central level, it is admitted that force production is controlled by the activation of
      contralateral motor areas. In COPD, these areas were found to be less activated than in
      controls during force production (Alexandre et al., 2014). However, recent studies bring the
      evidence that ipsilateral motor areas are also mobilized to cope demand during such task. The
      activation of ipsilateral areas is possible through inter hemispheric pathways, as the corpus
      callosum. Recently, the integrity of the corpus callosum have been linked to the capability
      of activating the ipsilateral motor cortex (Chiou et al., 2014) during force production. This
      is of concern knowing that several studies reported white matter lesions in the brain of COPD
      patients (Dodd et al, 2012) and more precisely in regions containing the corpus callosum
      (Lahousse et al., 2013).

      Therefore, we hypothesize that COPD patients have a lower capability of activating their
      ipsilateral motor cortex during force production compared to controls.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: COPD Patients vs. Controls
primary purpose: Basic Science
masking: None (Open Label)
measure: Ipsilateral excitability ratio : rest - 50% mvic
time frame: Baseline
description: Ratio of ipsilateral excitability. Measured at rest, and during a 50% max. isometric contraction. Then, ipsilateral excitability ratio = rest / 50% * 100.
measure: Ipsilateral inhibition ratio : rest - 50% mvic
time frame: Baseline
description: Ratio of ipsilateral inhibition. Measured at rest, and during a 50% max. isometric contraction. Then, ipsilateral inhibition ratio = rest / 50% * 100. SICI (2ms) method is used to quantify inhibition.
measure: Interhemispheric inhibition
time frame: Baseline
description: Interhemispheric inhibition, from contralateral to ipsilateral motor cortex, using reference method from Ferbert et al., 1992.
measure: Relationship between inter hemispheric inhibition and voluntary strength
time frame: Baseline
description: Correlation coefficient between inter hemispheric inhibition and maximal isometric force production
measure: S100B and GFAP
time frame: Baseline
description: Serum concentrations of S100B and GFAP proteins, brain lesions markers
arm group label: COPD patients group
arm group type: Experimental
description: COPD patients undergoing transcranial magnetic stimulation (TMS) evaluations.
arm group label: Controls group
arm group type: Active Comparator
description: Healthy matched controls undergoing transcranial magnetic stimulation (TMS) evaluations.
intervention type: Other
intervention name: Transcranial magnetic stimulation (TMS)
description: Evaluations by TMS
arm group label: COPD patients group
arm group label: Controls group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nicolas Oliver, MD
role: Principal Investigator
affiliation: 5 Santé
facility: 
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No