<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/NCT03817073</url>
  </required_header>
  <id_info>
    <org_study_id>TMALA19JVDW01</org_study_id>
    <nct_id>NCT03817073</nct_id>
  </id_info>
  <brief_title>Assessing Fatiguability of Tongue Muscles in MS</brief_title>
  <official_title>Assessing Fatiguability of Tongue Muscles and the Effect on Tongue Strength and Swallowing Pressures in Patients With Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas More Kempen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Revalidatie &amp; MS Centrum Overpelt</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Thomas More Kempen</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Multiple Sclerosis (MS) patients with subjective dysphagia will be tested for tongue strength&#xD;
      fatigue using a strictly defined fatigue paradigm. A maximum of 40 sets will be performed,&#xD;
      each set consisting of 5 repetitions of 80% of maximum isometric pressure (MIP) at the&#xD;
      anterior tongue, followed by a MIP at the anterior tongue. Cut-off criteria are a MIP &lt;50% of&#xD;
      the baseline MIP, pronounced subjective discomfort and/or exceeding the allocated test time&#xD;
      of 30 minutes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligibility is Mini-Mental State Exam-score (MMSE) &gt; 23, a Eating Assessment Tool-score&#xD;
      (EAT-10) &gt; 3, or a Functional Oral Intake Scale-score (FOIS) &lt; 7, or failing the Yale Swallow&#xD;
      Protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">July 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2021</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of successful repetitions</measure>
    <time_frame>30 minutes</time_frame>
    <description>The number of repetitions where the target force was developed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evolution of MIP during subsequent repetitions</measure>
    <time_frame>30 minutes</time_frame>
    <description>The change in MIP after each 5 repetitions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Baseline MIP as predictor for number of repetitions</measure>
    <time_frame>30 minutes</time_frame>
    <description>Does baseline MIP predict the number of successful repetitions.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Muscle Weakness</condition>
  <condition>Fatigue</condition>
  <condition>Multiple Sclerosis</condition>
  <condition>Deglutition Disorders</condition>
  <condition>Exertion; Excess</condition>
  <arm_group>
    <arm_group_label>Iowa Oral Performance Instrument (IOPI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All MS patients will be included in this arm to compare with a historical control arm. Iowa Oral Performance Instrument (IOPI).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Iowa Oral Performance Instrument (IOPI)</intervention_name>
    <description>Using biofeedback to attain repetitions of 80% of baseline MIP.</description>
    <arm_group_label>Iowa Oral Performance Instrument (IOPI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  proven MS&#xD;
&#xD;
          -  subjective dysphagia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  MMSE &lt; 23&#xD;
&#xD;
          -  major head and neck surgery&#xD;
&#xD;
          -  history of cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Vanderwegen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thomas More University College</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jan Vanderwegen, MD</last_name>
    <phone>03 241 08 29</phone>
    <email>jan.vanderwegen@thomasmore.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>Thomas More University College of Applied Sciences</name>
      <address>
        <city>Antwerp</city>
        <state>Antwerpen</state>
        <zip>2018</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <contact>
      <last_name>JAN VANDERWEGEN, MD</last_name>
      <phone>+32 3 241 08 29</phone>
      <email>jan.vanderwegen@thomasmore.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Thomas More Kempen</investigator_affiliation>
    <investigator_full_name>Jan Vanderwegen</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</mesh_term>
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</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/NCT03817073
org study id: TMALA19JVDW01
nct id: NCT03817073
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Multiple Sclerosis (MS) patients with subjective dysphagia will be tested for tongue strength
      fatigue using a strictly defined fatigue paradigm. A maximum of 40 sets will be performed,
      each set consisting of 5 repetitions of 80% of maximum isometric pressure (MIP) at the
      anterior tongue, followed by a MIP at the anterior tongue. Cut-off criteria are a MIP <50% of
      the baseline MIP, pronounced subjective discomfort and/or exceeding the allocated test time
      of 30 minutes.
Eligibility is Mini-Mental State Exam-score (MMSE) > 23, a Eating Assessment Tool-score
      (EAT-10) > 3, or a Functional Oral Intake Scale-score (FOIS) < 7, or failing the Yale Swallow
      Protocol.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Number of successful repetitions
time frame: 30 minutes
description: The number of repetitions where the target force was developed.
measure: Evolution of MIP during subsequent repetitions
time frame: 30 minutes
description: The change in MIP after each 5 repetitions.
measure: Baseline MIP as predictor for number of repetitions
time frame: 30 minutes
description: Does baseline MIP predict the number of successful repetitions.
arm group label: Iowa Oral Performance Instrument (IOPI)
arm group type: Experimental
description: All MS patients will be included in this arm to compare with a historical control arm. Iowa Oral Performance Instrument (IOPI).
intervention type: Device
intervention name: Iowa Oral Performance Instrument (IOPI)
description: Using biofeedback to attain repetitions of 80% of baseline MIP.
arm group label: Iowa Oral Performance Instrument (IOPI)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jan Vanderwegen
role: Principal Investigator
affiliation: Thomas More University College
last name: Jan Vanderwegen, MD
phone: 03 241 08 29
email: jan.vanderwegen@thomasmore.be
facility: 
contact: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Thomas More Kempen
investigator full name: Jan Vanderwegen
investigator title: Principal Investigator, Clinical Professor
mesh term: Muscle Weakness
mesh term: Deglutition Disorders
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No