<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/NCT03240965</url>
  </required_header>
  <id_info>
    <org_study_id>GI-149/16</org_study_id>
    <nct_id>NCT03240965</nct_id>
  </id_info>
  <brief_title>Changes in Sensitivity, Taste and Smell in Stroke Patients</brief_title>
  <acronym>5S</acronym>
  <official_title>Changes in Sensitivity of Swallowing-relevant Structures, Taste and Smell in Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Giessen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Giessen</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>
      This study evaluates changes in swallowing using endoscopic swallowing studies and measuring&#xD;
      of pharyngeal sensitivity, taste and smell in stroke patients. Younger (&lt;60 years) and older&#xD;
      (&gt;60 years) volunteers will serve as control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke is the second leading cause of death. At least 50% of stroke patients develop&#xD;
      dysphagia, leading to aspiration pneumonia, which is the main cause of death in stroke [2].&#xD;
&#xD;
      It is assumed that normal sensitivity is vital for aspiration-free swallowing and for the&#xD;
      triggering of the swallowing reflex.&#xD;
&#xD;
      Ali et al. demonstrated aspiration-free swallowing in healthy volunteers who underwent local&#xD;
      anaesthesia of oral and pharyngeal structures [1]. Power et al. showed a reduced sensitivity&#xD;
      of pharyngeal structures in stroke patients prone to aspiration [3].&#xD;
&#xD;
      By combining measuring sensitivity and flexible endoscopic swallowing studies, this study&#xD;
      further investigates the role of sensitivity in swallowing Neuropsychological deficits of&#xD;
      swallowing, such as swallowing apraxia or buccal hemineglect, is assessed by&#xD;
      neuropsychological testing.&#xD;
&#xD;
      Additionally, there is no systematic research investigating the change in smell and taste in&#xD;
      correlation with changes in stroke patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">February 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dysphagia</measure>
    <time_frame>96 hours after initial symptoms</time_frame>
    <description>Changes found in endoscopic swallowing study :&#xD;
Presence and severity of dysphagia (measured with Rosenbek's Penetration/Aspiration-scale)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological deficits</measure>
    <time_frame>96 hours after initial symptoms</time_frame>
    <description>Agnosia, neglect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lesion site</measure>
    <time_frame>96 hours after initial symptoms</time_frame>
    <description>Side, vascular territory, swallowing relevant structures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity</measure>
    <time_frame>96 hours after initial symptoms</time_frame>
    <description>Sensitivity of faucial pillar region</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Taste/Smell</measure>
    <time_frame>96 hours after initial symptoms</time_frame>
    <description>Smell-/Taste-score</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Dysphagia</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Volunteers &lt;60 years</arm_group_label>
    <description>Volunteers, who are able to consent to participation in the study, as control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Volunteers &gt;60 years</arm_group_label>
    <description>Volunteers, who are able to consent to participation in the study, as control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stroke patients</arm_group_label>
    <description>Stroke patients with supratentorial stroke, who are able to consent to participation in the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>FEES (flexible endoscopic evaluation of swallowing)</intervention_name>
    <description>Endoscopical swallowing study in stroke patients only</description>
    <arm_group_label>Stroke patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sensitivity threshold</intervention_name>
    <description>Determining sensitivity threshold using a pudendal electrode</description>
    <arm_group_label>Stroke patients</arm_group_label>
    <arm_group_label>Volunteers &lt;60 years</arm_group_label>
    <arm_group_label>Volunteers &gt;60 years</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Taste-/smell-test</intervention_name>
    <description>Taste-/smell-test</description>
    <arm_group_label>Stroke patients</arm_group_label>
    <arm_group_label>Volunteers &lt;60 years</arm_group_label>
    <arm_group_label>Volunteers &gt;60 years</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Neuropsychological testing</intervention_name>
    <description>Neuropsychological testing for neglect, agnosia</description>
    <arm_group_label>Stroke patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Stroke patients are recruited in a university hospital's department of neurology.&#xD;
&#xD;
        Volunteers &gt;60years are recruited in a trauma surgery ward at the same university hospital.&#xD;
&#xD;
        Volunteers &lt;60 are recruited without specified characteristics (aside from in-/exclusion&#xD;
        criteria).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Volunteers:&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Stroke patients:&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  new supratentorial stroke (&lt;72 hours old) confirmed by CT (computed tomography) or MRI&#xD;
             (magnetic resonance imaging)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pre-existing stroke oder dysphagia&#xD;
&#xD;
          -  extensive white matter lesions in CT- or MRI-scan&#xD;
&#xD;
          -  allergies to odorous substances or flavoring&#xD;
&#xD;
          -  contraindications for FEES (flexible endoscopic evaluation of swallowing), CT or MRI&#xD;
             (stroke patients only)&#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_official>
    <last_name>Tobias Braun, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Giessen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tobias Braun, M.D.</last_name>
    <phone>+49(0)-641-985</phone>
    <phone_ext>56827</phone_ext>
    <email>tobias.braun@neuro.med.uni-giessen.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universitätsklinikum Gießen</name>
      <address>
        <city>Gießen</city>
        <state>Hessen</state>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tobias Braun, M.D.</last_name>
      <phone>+49 641 985</phone>
      <phone_ext>56827</phone_ext>
      <email>tobias.braun@neuro.med.uni-giessen.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Ali GN, Laundl TM, Wallace KL, Shaw DW, Decarle DJ, Cook IJ. Influence of mucosal receptors on deglutitive regulation of pharyngeal and upper esophageal sphincter function. Am J Physiol. 1994 Oct;267(4 Pt 1):G644-9. doi: 10.1152/ajpgi.1994.267.4.G644.</citation>
    <PMID>7943330</PMID>
  </reference>
  <reference>
    <citation>Kidd D, Lawson J, Nesbitt R, MacMahon J. Aspiration in acute stroke: a clinical study with videofluoroscopy. Q J Med. 1993 Dec;86(12):825-9.</citation>
    <PMID>8108539</PMID>
  </reference>
  <reference>
    <citation>Power ML, Hamdy S, Singh S, Tyrrell PJ, Turnbull I, Thompson DG. Deglutitive laryngeal closure in stroke patients. J Neurol Neurosurg Psychiatry. 2007 Feb;78(2):141-6. doi: 10.1136/jnnp.2006.101857. Epub 2006 Sep 29.</citation>
    <PMID>17012336</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>June 13, 2022</last_update_submitted>
  <last_update_submitted_qc>June 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Giessen</investigator_affiliation>
    <investigator_full_name>Tobias Braun</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03240965
org study id: GI-149/16
nct id: NCT03240965
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates changes in swallowing using endoscopic swallowing studies and measuring
      of pharyngeal sensitivity, taste and smell in stroke patients. Younger (<60 years) and older
      (>60 years) volunteers will serve as control.
Stroke is the second leading cause of death. At least 50% of stroke patients develop
      dysphagia, leading to aspiration pneumonia, which is the main cause of death in stroke [2].

      It is assumed that normal sensitivity is vital for aspiration-free swallowing and for the
      triggering of the swallowing reflex.

      Ali et al. demonstrated aspiration-free swallowing in healthy volunteers who underwent local
      anaesthesia of oral and pharyngeal structures [1]. Power et al. showed a reduced sensitivity
      of pharyngeal structures in stroke patients prone to aspiration [3].

      By combining measuring sensitivity and flexible endoscopic swallowing studies, this study
      further investigates the role of sensitivity in swallowing Neuropsychological deficits of
      swallowing, such as swallowing apraxia or buccal hemineglect, is assessed by
      neuropsychological testing.

      Additionally, there is no systematic research investigating the change in smell and taste in
      correlation with changes in stroke patients
observational model: Case-Only
time perspective: Prospective
measure: Dysphagia
time frame: 96 hours after initial symptoms
description: Changes found in endoscopic swallowing study :
Presence and severity of dysphagia (measured with Rosenbek's Penetration/Aspiration-scale)
measure: Neuropsychological deficits
time frame: 96 hours after initial symptoms
description: Agnosia, neglect
measure: Lesion site
time frame: 96 hours after initial symptoms
description: Side, vascular territory, swallowing relevant structures
measure: Sensitivity
time frame: 96 hours after initial symptoms
description: Sensitivity of faucial pillar region
measure: Taste/Smell
time frame: 96 hours after initial symptoms
description: Smell-/Taste-score
arm group label: Volunteers <60 years
description: Volunteers, who are able to consent to participation in the study, as control.
arm group label: Volunteers >60 years
description: Volunteers, who are able to consent to participation in the study, as control.
arm group label: Stroke patients
description: Stroke patients with supratentorial stroke, who are able to consent to participation in the study.
intervention type: Diagnostic Test
intervention name: FEES (flexible endoscopic evaluation of swallowing)
description: Endoscopical swallowing study in stroke patients only
arm group label: Stroke patients
intervention type: Other
intervention name: Sensitivity threshold
description: Determining sensitivity threshold using a pudendal electrode
arm group label: Stroke patients
arm group label: Volunteers <60 years
arm group label: Volunteers >60 years
intervention type: Diagnostic Test
intervention name: Taste-/smell-test
description: Taste-/smell-test
arm group label: Stroke patients
arm group label: Volunteers <60 years
arm group label: Volunteers >60 years
intervention type: Diagnostic Test
intervention name: Neuropsychological testing
description: Neuropsychological testing for neglect, agnosia
arm group label: Stroke patients
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: Tobias Braun, M.D.
role: Principal Investigator
affiliation: University Giessen
last name: Tobias Braun, M.D.
phone: +49(0)-641-985
phone ext: 56827
email: tobias.braun@neuro.med.uni-giessen.de
facility: 
status: Recruiting
contact: 
country: Germany
citation: Ali GN, Laundl TM, Wallace KL, Shaw DW, Decarle DJ, Cook IJ. Influence of mucosal receptors on deglutitive regulation of pharyngeal and upper esophageal sphincter function. Am J Physiol. 1994 Oct;267(4 Pt 1):G644-9. doi: 10.1152/ajpgi.1994.267.4.G644.
PMID: 7943330
citation: Kidd D, Lawson J, Nesbitt R, MacMahon J. Aspiration in acute stroke: a clinical study with videofluoroscopy. Q J Med. 1993 Dec;86(12):825-9.
PMID: 8108539
citation: Power ML, Hamdy S, Singh S, Tyrrell PJ, Turnbull I, Thompson DG. Deglutitive laryngeal closure in stroke patients. J Neurol Neurosurg Psychiatry. 2007 Feb;78(2):141-6. doi: 10.1136/jnnp.2006.101857. Epub 2006 Sep 29.
PMID: 17012336
responsible party type: Principal Investigator
investigator affiliation: University of Giessen
investigator full name: Tobias Braun
investigator title: Principal Investigator
mesh term: Stroke
sharing ipd: Undecided