<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/NCT04457622</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL20_0333</org_study_id>
    <secondary_id>2020-A01231-38</secondary_id>
    <nct_id>NCT04457622</nct_id>
  </id_info>
  <brief_title>Language and Brain Rhythms</brief_title>
  <acronym>LaBRhythms</acronym>
  <official_title>Language and Brain Rhythms</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>
      For humans and other animals, predicting the timing of sensory events is essential for their&#xD;
      daily behavior. Importantly, natural sensory stimulation (such as movements, music, or&#xD;
      speech) can present temporal regularities allowing for temporal prediction of incoming&#xD;
      sensory information. For instance, individuals can easily predict in time the next step of a&#xD;
      walker, or the next beat of a song based on the rhythm. The phenomenon of temporal prediction&#xD;
      has for now only been investigated experimentally in deterministic scenarios, i.e. when the&#xD;
      duration between two sensory events is fixed, or when stimuli present a regular beat. The&#xD;
      objective of this project is to understand how we process more natural, hence more complex&#xD;
      forms of temporal regularities, and how individuals make inferences on the timing of sensory&#xD;
      events based on past temporal statistics of sensory information. This is particularly&#xD;
      important for speech processing, considering that speech is an acoustic signal that is known&#xD;
      to possess some form of temporal regularity, and yet is not purely rhythmic nor does have a&#xD;
      deterministic temporal structure. Temporal regularities are specific to each spoken language,&#xD;
      and both native and non-native language listeners are known to use temporal acoustic cues&#xD;
      during speech listening. This affects speech comprehension and has a strong impact during&#xD;
      language learning. Hence, understanding the processing of temporal regularities in speech can&#xD;
      help improve language abilities in first and second language learners.&#xD;
&#xD;
      The project is composed of four experiments. The first behavioral experiment will investigate&#xD;
      how auditory perception is affected by the temporal statistics of past sensory information&#xD;
      using artificial stimuli. The second axis will investigate the neural mechanisms underlying&#xD;
      auditory timing processing with electroencephalography (EEG). The last Magnetoencephalography&#xD;
      (MEG, experiment 3) and EG (rxperiement 4) experiment will test the role of temporal&#xD;
      statistics in an ecological setting, namely speech listening. The project will thus provide&#xD;
      strong theoretical advances as it will give new insights on brain mechanisms for the&#xD;
      processing of complex temporal information in audition and speech, and their role in language&#xD;
      comprehension. It will also provide methodological advances. Specifically, the project will&#xD;
      contribute to the development and validation of cutting-edge methods in MEG. Namely, it will&#xD;
      aim at creating new tools to investigate the neural correlates of auditory and speech&#xD;
      processing with an unprecedented temporal and spatial resolution.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 18, 2021</start_date>
  <completion_date type="Anticipated">October 18, 2025</completion_date>
  <primary_completion_date type="Anticipated">October 18, 2025</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stimulus-Brain (EEG) Coherence in the delta-theta range (1 Hz - 8 Hz)</measure>
    <time_frame>at max 90 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Amplitude of EEG evoked responses to the target stimuli</measure>
    <time_frame>at max 90 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Stimulus-Brain (MEG) Coherence in the delta-theta range (1 Hz - 8 Hz)</measure>
    <time_frame>at max 90 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Amplitude of MEG evoked responses to the target stimuli</measure>
    <time_frame>at max 90 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of correct responses</measure>
    <time_frame>at max 90 days</time_frame>
    <description>The secondary outcome measures will be recorded in all experiments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response Times</measure>
    <time_frame>at max 90 days</time_frame>
    <description>The secondary outcome measures will be recorded in all experiments</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">366</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Main study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants signed up for experiment 1, 2, 3 or 4 complete the same protocol (1 study arm) with an intent for intra-subject correlational analyses</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Auditory perception tasks in healthy participants</intervention_name>
    <description>The participants complete auditory perception tasks while EEG, and MEG record brain signals (primary outcome measure). The tasks acquire behavioral responses with button presses (secondary outcome measure).&#xD;
All analyses are intra-subject (no analyses are between-subject).</description>
    <arm_group_label>Main study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For all experiments:&#xD;
&#xD;
          -  18- 40 years old&#xD;
&#xD;
          -  Registration with the French healthcare system&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Normal hearing&#xD;
&#xD;
        Additionally, for experiments 2,3 and 4 :&#xD;
&#xD;
        - Right handed&#xD;
&#xD;
        Additionally, for experiment 3:&#xD;
&#xD;
        - French as native language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For All Experiments:&#xD;
&#xD;
          -  Neurological or psychiatric illnesses or a history of such problems that could impact&#xD;
             quality/variability of data or cooperation and retention of the subject in the study&#xD;
&#xD;
          -  Regular use of medications that impact the central nervous system&#xD;
&#xD;
          -  Regular use of medications, such as opioids and antidepressants, including SSRIs and&#xD;
             tricyclic antidepressants&#xD;
&#xD;
          -  Severe hearing loss&#xD;
&#xD;
          -  A history of stroke or recent trauma to the head&#xD;
&#xD;
          -  Persons unable to adhere to abstinence from the use of drugs or alcohol the day or&#xD;
             evening before experimental sessions&#xD;
&#xD;
          -  Women who are pregnant, breastfeeding, or have given birth in the last 6 months&#xD;
&#xD;
        Additionally, for experiment 2,3 and 4 :&#xD;
&#xD;
          -  A pacemaker, insulin or other pump, neurostimulator, cochlear implants or other&#xD;
             hearing aid, metal stents, prosthesis, or implants, intracerebral clips, implantable&#xD;
             defibrillator, cerebral shunt or ventricular catheter, other foreign metal objects in&#xD;
             the upper part of the body&#xD;
&#xD;
          -  any dental apparatus containing metal including or root canals&#xD;
&#xD;
          -  any foreign metallic object anywhere in the body&#xD;
&#xD;
          -  bolts, screws&#xD;
&#xD;
          -  orthopedic devices or implants&#xD;
&#xD;
        Additionally, for experiment 3:&#xD;
&#xD;
          -  claustrophobia&#xD;
&#xD;
          -  glasses (given the participant cannot use contact lenses)&#xD;
&#xD;
          -  a head size incompatible with the use of a personalized 3D headcast or a&#xD;
             magnetoencephalography&#xD;
&#xD;
          -  Persons having had any surgery prior to the study which puts them at risk for metal&#xD;
             objects left in the body&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne KOSEM, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre de recherche de Neurosciences de Lyon (CRNL)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anne KOSEM, PhD</last_name>
    <phone>4.72.13.89.16</phone>
    <phone_ext>+33</phone_ext>
    <email>anne.kosem@inserm.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mathilde Bonnefond, PhD</last_name>
    <phone>4 72 13 89 03</phone>
    <phone_ext>+33</phone_ext>
    <email>mathilde.bonnefond@inserm.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre de Recherche en Neuroscience de Lyon</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne KOSEM, PhD</last_name>
      <phone>4.72.13.89.16</phone>
      <phone_ext>+33</phone_ext>
      <email>anne.kosem@inserm.fr</email>
    </contact>
    <contact_backup>
      <last_name>Mathilde BONNEFOND, PhD</last_name>
      <phone>4 72 13 89 03</phone>
      <phone_ext>+33</phone_ext>
      <email>mathilde.bonnefond@inserm.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Anne KOSEM, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mathilde BONNEFOND, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Auditory Perception</keyword>
  <keyword>Speech</keyword>
  <keyword>Neuroimaging</keyword>
  <!-- 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/NCT04457622
org study id: 69HCL20_0333
secondary id: 2020-A01231-38
nct id: NCT04457622
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
For humans and other animals, predicting the timing of sensory events is essential for their
      daily behavior. Importantly, natural sensory stimulation (such as movements, music, or
      speech) can present temporal regularities allowing for temporal prediction of incoming
      sensory information. For instance, individuals can easily predict in time the next step of a
      walker, or the next beat of a song based on the rhythm. The phenomenon of temporal prediction
      has for now only been investigated experimentally in deterministic scenarios, i.e. when the
      duration between two sensory events is fixed, or when stimuli present a regular beat. The
      objective of this project is to understand how we process more natural, hence more complex
      forms of temporal regularities, and how individuals make inferences on the timing of sensory
      events based on past temporal statistics of sensory information. This is particularly
      important for speech processing, considering that speech is an acoustic signal that is known
      to possess some form of temporal regularity, and yet is not purely rhythmic nor does have a
      deterministic temporal structure. Temporal regularities are specific to each spoken language,
      and both native and non-native language listeners are known to use temporal acoustic cues
      during speech listening. This affects speech comprehension and has a strong impact during
      language learning. Hence, understanding the processing of temporal regularities in speech can
      help improve language abilities in first and second language learners.

      The project is composed of four experiments. The first behavioral experiment will investigate
      how auditory perception is affected by the temporal statistics of past sensory information
      using artificial stimuli. The second axis will investigate the neural mechanisms underlying
      auditory timing processing with electroencephalography (EEG). The last Magnetoencephalography
      (MEG, experiment 3) and EG (rxperiement 4) experiment will test the role of temporal
      statistics in an ecological setting, namely speech listening. The project will thus provide
      strong theoretical advances as it will give new insights on brain mechanisms for the
      processing of complex temporal information in audition and speech, and their role in language
      comprehension. It will also provide methodological advances. Specifically, the project will
      contribute to the development and validation of cutting-edge methods in MEG. Namely, it will
      aim at creating new tools to investigate the neural correlates of auditory and speech
      processing with an unprecedented temporal and spatial resolution.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Stimulus-Brain (EEG) Coherence in the delta-theta range (1 Hz - 8 Hz)
time frame: at max 90 days
measure: Amplitude of EEG evoked responses to the target stimuli
time frame: at max 90 days
measure: Stimulus-Brain (MEG) Coherence in the delta-theta range (1 Hz - 8 Hz)
time frame: at max 90 days
measure: Amplitude of MEG evoked responses to the target stimuli
time frame: at max 90 days
measure: Percentage of correct responses
time frame: at max 90 days
description: The secondary outcome measures will be recorded in all experiments
measure: Response Times
time frame: at max 90 days
description: The secondary outcome measures will be recorded in all experiments
arm group label: Main study group
arm group type: Experimental
description: All participants signed up for experiment 1, 2, 3 or 4 complete the same protocol (1 study arm) with an intent for intra-subject correlational analyses
intervention type: Other
intervention name: Auditory perception tasks in healthy participants
description: The participants complete auditory perception tasks while EEG, and MEG record brain signals (primary outcome measure). The tasks acquire behavioral responses with button presses (secondary outcome measure).
All analyses are intra-subject (no analyses are between-subject).
arm group label: Main study group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anne KOSEM, PhD
role: Principal Investigator
affiliation: Centre de recherche de Neurosciences de Lyon (CRNL)
last name: Anne KOSEM, PhD
phone: 4.72.13.89.16
phone ext: +33
email: anne.kosem@inserm.fr
last name: Mathilde Bonnefond, PhD
phone: 4 72 13 89 03
phone ext: +33
email: mathilde.bonnefond@inserm.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor