<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/NCT02974530</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A00070-51</org_study_id>
    <nct_id>NCT02974530</nct_id>
  </id_info>
  <brief_title>Description and Modeling of Swallowing Disorders After a Stroke</brief_title>
  <acronym>AVC-MODE</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Research Agency, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier du Pays d'Aix</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Université Joseph Fourier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The oropharyngeal junction participates in 3 interpenetrating functions: Swallowing,&#xD;
      Breathing and Speech. In the context of ischemic or hemorrhagic stroke, these are altered,&#xD;
      isolated or associated manner, causing major disorders and representing a source of handicap&#xD;
      for patients.&#xD;
&#xD;
      Understanding the swallowing mechanisms is therefore a major challenge to guide the&#xD;
      rehabilitation and improve the initial and long-term prognosis of patients with stroke.&#xD;
&#xD;
      The main objective of this study is to describe and modeling, thanks to a clinical,&#xD;
      physiological and radiological knowledge base, swallowing, speech and breathing, in patients&#xD;
      with stroke and in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Clinical severity score</measure>
    <time_frame>At inclusion and 6 months after diagnosis</time_frame>
    <description>NIHSS scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of swallowing disorder</measure>
    <time_frame>Within 15 days after diagnosis and 6 months after diagnosis</time_frame>
    <description>Test : GUgging Swallowing Screen</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of aphasia disorder</measure>
    <time_frame>Within 15 days after diagnosis and 6 months after diagnosis</time_frame>
    <description>Questionnaire : Aphasia rapid test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of state of depression and anxiety</measure>
    <time_frame>Within 15 days after diagnosis and 6 months after diagnosis</time_frame>
    <description>Questionnaire : anxiety and depression scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of behavioural attention</measure>
    <time_frame>Within 15 days after diagnosis and 6 months after diagnosis</time_frame>
    <description>Questionnaire : Catherine Bergego scale</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Stroke</condition>
  <condition>Swallowing Disorders</condition>
  <arm_group>
    <arm_group_label>Stroke population</arm_group_label>
    <description>Patient with stroke will be explored during their acute phase and in 6 months of diagnosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy population</arm_group_label>
    <description>Healthy subjects will be explored in Grenoble in research laboratory</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neurological evaluation</intervention_name>
    <arm_group_label>Stroke population</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laryngological evaluation</intervention_name>
    <arm_group_label>Stroke population</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI evaluation</intervention_name>
    <arm_group_label>Stroke population</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breathing investigation</intervention_name>
    <arm_group_label>Healthy population</arm_group_label>
    <arm_group_label>Stroke population</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI and articulatory investigation</intervention_name>
    <arm_group_label>Healthy population</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Postural investigation</intervention_name>
    <arm_group_label>Healthy population</arm_group_label>
    <arm_group_label>Stroke population</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Voice and soundscape investigation</intervention_name>
    <arm_group_label>Healthy population</arm_group_label>
    <arm_group_label>Stroke population</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Multicenter study with two cohorts unpaired : first of healthy subjects / second of patient&#xD;
        with ischemic stroke.&#xD;
&#xD;
        Study size expected :&#xD;
&#xD;
          -  120 stroke patients in 4 University Hospital&#xD;
&#xD;
          -  30 healthy subjects explored in research laboratory&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        For patients after stroke&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  First stroke confirmed by MRI &lt; 15 days&#xD;
&#xD;
          -  No severe leukoaraiosis&#xD;
&#xD;
          -  Swallowing disorders identified (GUSS scale &lt; 20)&#xD;
&#xD;
          -  Neurological deficit identified (NIHSS scale &lt;15)&#xD;
&#xD;
          -  Patient able to cooperate for investigations&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cerebral hemorrhage&#xD;
&#xD;
          -  History of neurological disease that can lead to swallowing disorders&#xD;
&#xD;
          -  History of laryngological disease such as previous surgery or radiation neck&#xD;
&#xD;
          -  Tracheotomy&#xD;
&#xD;
          -  Vigilance disorders&#xD;
&#xD;
          -  Pregnant, parturient or nursing woman&#xD;
&#xD;
          -  Protected adult&#xD;
&#xD;
          -  Simultaneous participation in another study&#xD;
&#xD;
          -  Non registered to the French social security system&#xD;
&#xD;
        For healthy subjects&#xD;
&#xD;
        Inclusion Criteria :&#xD;
&#xD;
          -  Age between 18 and 40 years old&#xD;
&#xD;
          -  French native speaker&#xD;
&#xD;
          -  Normal hearing with or without corrective&#xD;
&#xD;
          -  No oral or written language disorders&#xD;
&#xD;
          -  No neurological or psychiatric disorders&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  MRI contraindication&#xD;
&#xD;
          -  Pregnant, parturient or nursing woman&#xD;
&#xD;
          -  Simultaneous participation in another study&#xD;
&#xD;
          -  Non registered to the French social security system&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Marc Hommel, MD</last_name>
    <email>mhommel@ujf-grenoble.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Philippe Cousin</last_name>
    <email>philippe.cousin@agim.eu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital</name>
      <address>
        <city>Aix en Provence</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Dominique Gayraud, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University hospital</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Emmanuel Touze, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University hospital</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Olivier Detante, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University hospital</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Nicolas Menjot de Champfleur, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 1, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>July 12, 2017</last_update_submitted>
  <last_update_submitted_qc>July 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</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/NCT02974530
org study id: 2016-A00070-51
nct id: NCT02974530
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The oropharyngeal junction participates in 3 interpenetrating functions: Swallowing,
      Breathing and Speech. In the context of ischemic or hemorrhagic stroke, these are altered,
      isolated or associated manner, causing major disorders and representing a source of handicap
      for patients.

      Understanding the swallowing mechanisms is therefore a major challenge to guide the
      rehabilitation and improve the initial and long-term prognosis of patients with stroke.

      The main objective of this study is to describe and modeling, thanks to a clinical,
      physiological and radiological knowledge base, swallowing, speech and breathing, in patients
      with stroke and in healthy subjects.
observational model: Cohort
time perspective: Prospective
measure: Change of Clinical severity score
time frame: At inclusion and 6 months after diagnosis
description: NIHSS scale
measure: Change of swallowing disorder
time frame: Within 15 days after diagnosis and 6 months after diagnosis
description: Test : GUgging Swallowing Screen
measure: Change of aphasia disorder
time frame: Within 15 days after diagnosis and 6 months after diagnosis
description: Questionnaire : Aphasia rapid test
measure: Change of state of depression and anxiety
time frame: Within 15 days after diagnosis and 6 months after diagnosis
description: Questionnaire : anxiety and depression scale
measure: Change of behavioural attention
time frame: Within 15 days after diagnosis and 6 months after diagnosis
description: Questionnaire : Catherine Bergego scale
arm group label: Stroke population
description: Patient with stroke will be explored during their acute phase and in 6 months of diagnosis.
arm group label: Healthy population
description: Healthy subjects will be explored in Grenoble in research laboratory
intervention type: Other
intervention name: Neurological evaluation
arm group label: Stroke population
intervention type: Other
intervention name: Laryngological evaluation
arm group label: Stroke population
intervention type: Other
intervention name: MRI evaluation
arm group label: Stroke population
intervention type: Other
intervention name: Breathing investigation
arm group label: Healthy population
arm group label: Stroke population
intervention type: Other
intervention name: MRI and articulatory investigation
arm group label: Healthy population
intervention type: Other
intervention name: Postural investigation
arm group label: Healthy population
arm group label: Stroke population
intervention type: Other
intervention name: Voice and soundscape investigation
arm group label: Healthy population
arm group label: Stroke population
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marc Hommel, MD
email: mhommel@ujf-grenoble.fr
last name: Philippe Cousin
email: philippe.cousin@agim.eu
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
country: France
responsible party type: Sponsor
mesh term: Deglutition Disorders
sharing ipd: No