<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/NCT03233282</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL16_0661</org_study_id>
    <nct_id>NCT03233282</nct_id>
  </id_info>
  <brief_title>EEG Monitoring for PERFormance Anticipation</brief_title>
  <acronym>MEEGAPERF</acronym>
  <official_title>Electrophysiological and Bioenergetic Study of Variations in Cognitive and Physical Performance in Healthy Humans: EEG Monitoring for PERFormance Anticipation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Identify, characterize and then validate electrophysiological markers linking&#xD;
      electrophysiological cerebral activity and performance in cognitive and physical fatigability&#xD;
      in humans. To do this, noninvasive explorations of electroencephalography (EEG) and&#xD;
      magnetoencephalography (MEG) will be carried out under two conditions of different&#xD;
      experiments, the first one that induces a cognitive fatigability and the second one that&#xD;
      induces physical fatigability.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 30, 2013</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Identify electrophysiological markers in humans depending on whether the experimental conditions induce cognitive fatigability.</measure>
    <time_frame>7 hours</time_frame>
    <description>The evaluation of cognitive performance will be carried out by means of conventional behavioral measures, of the press-button type, handling of a mouse or of a joystick and measurement of reaction time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identify electrophysiological markers in humans depending on whether the experimental conditions induce physical fatigability with EEG.</measure>
    <time_frame>7 hours</time_frame>
    <description>Electrophysiological measurements of cerebral activity will be performed by multi-sensor electroencephalography (EEG).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identify electrophysiological markers in humans depending on whether the experimental conditions induce physical fatigability with MEG.</measure>
    <time_frame>7 hours</time_frame>
    <description>Electrophysiological measurements of cerebral activity will be carried out by magnetoencephalography (MEG)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Refine (locate at the level of the cortex), the origin of these physiological markers</measure>
    <time_frame>7 hours</time_frame>
    <description>Several types of recordings, passive and non-invasive, will be realized:&#xD;
Electrooculogram (EOG);&#xD;
electromyography (EMG);&#xD;
electrocardiogram (ECG); Systematically in &quot;physical&quot; experiments and for some &quot;cognitive&quot; experiments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distinguish between different time scales of performance</measure>
    <time_frame>7 hours</time_frame>
    <description>Several types of recordings, passive and non-invasive, will be realized:&#xD;
electrodermogram (EDG);&#xD;
the consumption of O2 (VO2);&#xD;
production of CO2 (VCO2). Only and systematically, in &quot;physical&quot; experiments.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">169</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Cognitive Fatigability</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical Fatigability</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electroencephalography (EEG) multi-sensor</intervention_name>
    <description>Electrophysiological measurements of cerebral activity will be performed by multi-sensor electroencephalography (EEG), which is a non-invasive method.</description>
    <arm_group_label>Cognitive Fatigability</arm_group_label>
    <arm_group_label>Physical Fatigability</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Magnetoencephalography (MEG)</intervention_name>
    <description>Electrophysiological measurements of brain activity will be performed by magnetoencephalography (MEG) which is a non-invasive method.</description>
    <arm_group_label>Cognitive Fatigability</arm_group_label>
    <arm_group_label>Physical Fatigability</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Behavioral Measures</intervention_name>
    <description>The evaluation of cognitive performance will be carried out by means of behavioral measures, push-button type, handling of a mouse or a joystick.</description>
    <arm_group_label>Cognitive Fatigability</arm_group_label>
    <arm_group_label>Physical Fatigability</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Reaction time measurement</intervention_name>
    <description>The assessment of cognitive performance will be carried out using standard behavioral measures, such as reaction time measurement.</description>
    <arm_group_label>Cognitive Fatigability</arm_group_label>
    <arm_group_label>Physical Fatigability</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assessment of physical performance</intervention_name>
    <description>The assessment of physical performance will be based both on bioenergetic measurements and on quantitative data collected in continuous and relative to the effort (eg instantaneous pedaling speed).</description>
    <arm_group_label>Cognitive Fatigability</arm_group_label>
    <arm_group_label>Physical Fatigability</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electrooculogram (EOG)</intervention_name>
    <description>In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.</description>
    <arm_group_label>Cognitive Fatigability</arm_group_label>
    <arm_group_label>Physical Fatigability</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electromyogram (EMG)</intervention_name>
    <description>In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.</description>
    <arm_group_label>Cognitive Fatigability</arm_group_label>
    <arm_group_label>Physical Fatigability</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electrocardiogram with 3 leads</intervention_name>
    <description>In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.</description>
    <arm_group_label>Cognitive Fatigability</arm_group_label>
    <arm_group_label>Physical Fatigability</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electrodermogram (EDG)</intervention_name>
    <description>In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.</description>
    <arm_group_label>Physical Fatigability</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Consumption of O2 (VO2)</intervention_name>
    <description>In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.</description>
    <arm_group_label>Physical Fatigability</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Production of CO2 (VCO2)</intervention_name>
    <description>In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.</description>
    <arm_group_label>Physical Fatigability</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria MGPFco group:&#xD;
&#xD;
          -  Adult subjects, male or female, right-handed or left-handed, from 18 years up to 70&#xD;
             years;&#xD;
&#xD;
          -  Having duly completed the entire confidential medical questionnaire;&#xD;
&#xD;
          -  Written consent of free, informed and express participation;&#xD;
&#xD;
          -  No hearing problems;&#xD;
&#xD;
          -  Having normal or corrected vision;&#xD;
&#xD;
          -  Affiliation to a Social Security scheme.&#xD;
&#xD;
        Inclusion Criteria MGPFph group:&#xD;
&#xD;
          -  Adult subjects, male or female, right-handed or left-handed, from 18 years up to 35&#xD;
             years;&#xD;
&#xD;
          -  Practicing at least five hours of sports per week;&#xD;
&#xD;
          -  Presenting a certificate of no contraindication to an exercise test, intense sports&#xD;
             practice or an energy sport in competition of the current year;&#xD;
&#xD;
          -  Having duly completed the entire confidential medical questionnaire;&#xD;
&#xD;
          -  Without cardiovascular or motor disability;&#xD;
&#xD;
          -  Without tumoral, inflammatory, cardiac, pulmonary, renal, digestive (malabsorption&#xD;
             syndrome) or liver disease;&#xD;
&#xD;
          -  Written consent of free, informed and express participation;&#xD;
&#xD;
          -  Affiliation to a Social Security scheme.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women, nursing mothers or those of childbearing age without contraception&#xD;
&#xD;
          -  Persons under guardianship, curatorship or any other administrative or judicial&#xD;
             measure of deprivation of liberty or of liberty&#xD;
&#xD;
          -  Persons protected by the law&#xD;
&#xD;
          -  Persons who have performed a maximum stress test within 15 days of the date of&#xD;
             inclusion,&#xD;
&#xD;
          -  In the course of drug treatments against indicated for the protocol (treatment for&#xD;
             neurological diseases, psychiatric ...).&#xD;
&#xD;
          -  Metal implants incompatible with MRI (for the subjects concerned, see appendices)&#xD;
&#xD;
          -  Metallic implants incompatible with the MEG (for the subjects concerned, see&#xD;
             appendices)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julien JUNG, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospices Civils de Lyon, HFME</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>April 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>August 30, 2018</last_update_submitted>
  <last_update_submitted_qc>August 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03233282
org study id: 69HCL16_0661
nct id: NCT03233282
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Identify, characterize and then validate electrophysiological markers linking
      electrophysiological cerebral activity and performance in cognitive and physical fatigability
      in humans. To do this, noninvasive explorations of electroencephalography (EEG) and
      magnetoencephalography (MEG) will be carried out under two conditions of different
      experiments, the first one that induces a cognitive fatigability and the second one that
      induces physical fatigability.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Identify electrophysiological markers in humans depending on whether the experimental conditions induce cognitive fatigability.
time frame: 7 hours
description: The evaluation of cognitive performance will be carried out by means of conventional behavioral measures, of the press-button type, handling of a mouse or of a joystick and measurement of reaction time.
measure: Identify electrophysiological markers in humans depending on whether the experimental conditions induce physical fatigability with EEG.
time frame: 7 hours
description: Electrophysiological measurements of cerebral activity will be performed by multi-sensor electroencephalography (EEG).
measure: Identify electrophysiological markers in humans depending on whether the experimental conditions induce physical fatigability with MEG.
time frame: 7 hours
description: Electrophysiological measurements of cerebral activity will be carried out by magnetoencephalography (MEG)
measure: Refine (locate at the level of the cortex), the origin of these physiological markers
time frame: 7 hours
description: Several types of recordings, passive and non-invasive, will be realized:
Electrooculogram (EOG);
electromyography (EMG);
electrocardiogram (ECG); Systematically in "physical" experiments and for some "cognitive" experiments.
measure: Distinguish between different time scales of performance
time frame: 7 hours
description: Several types of recordings, passive and non-invasive, will be realized:
electrodermogram (EDG);
the consumption of O2 (VO2);
production of CO2 (VCO2). Only and systematically, in "physical" experiments.
arm group label: Cognitive Fatigability
arm group type: Other
arm group label: Physical Fatigability
arm group type: Other
intervention type: Other
intervention name: Electroencephalography (EEG) multi-sensor
description: Electrophysiological measurements of cerebral activity will be performed by multi-sensor electroencephalography (EEG), which is a non-invasive method.
arm group label: Cognitive Fatigability
arm group label: Physical Fatigability
intervention type: Other
intervention name: Magnetoencephalography (MEG)
description: Electrophysiological measurements of brain activity will be performed by magnetoencephalography (MEG) which is a non-invasive method.
arm group label: Cognitive Fatigability
arm group label: Physical Fatigability
intervention type: Other
intervention name: Behavioral Measures
description: The evaluation of cognitive performance will be carried out by means of behavioral measures, push-button type, handling of a mouse or a joystick.
arm group label: Cognitive Fatigability
arm group label: Physical Fatigability
intervention type: Other
intervention name: Reaction time measurement
description: The assessment of cognitive performance will be carried out using standard behavioral measures, such as reaction time measurement.
arm group label: Cognitive Fatigability
arm group label: Physical Fatigability
intervention type: Other
intervention name: Assessment of physical performance
description: The assessment of physical performance will be based both on bioenergetic measurements and on quantitative data collected in continuous and relative to the effort (eg instantaneous pedaling speed).
arm group label: Cognitive Fatigability
arm group label: Physical Fatigability
intervention type: Other
intervention name: Electrooculogram (EOG)
description: In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
arm group label: Cognitive Fatigability
arm group label: Physical Fatigability
intervention type: Other
intervention name: Electromyogram (EMG)
description: In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
arm group label: Cognitive Fatigability
arm group label: Physical Fatigability
intervention type: Other
intervention name: Electrocardiogram with 3 leads
description: In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
arm group label: Cognitive Fatigability
arm group label: Physical Fatigability
intervention type: Other
intervention name: Electrodermogram (EDG)
description: In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
arm group label: Physical Fatigability
intervention type: Other
intervention name: Consumption of O2 (VO2)
description: In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
arm group label: Physical Fatigability
intervention type: Other
intervention name: Production of CO2 (VCO2)
description: In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
arm group label: Physical Fatigability
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Julien JUNG, MD
role: Principal Investigator
affiliation: Hospices Civils de Lyon
facility: 
country: France
responsible party type: Sponsor