<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/NCT03770377</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201702917 -A</org_study_id>
    <secondary_id>R01DC016275-01A1</secondary_id>
    <secondary_id>OCR19032</secondary_id>
    <secondary_id>5R01DC016275-02</secondary_id>
    <nct_id>NCT03770377</nct_id>
  </id_info>
  <brief_title>Laryngeal Adaptation for Speech and Swallowing</brief_title>
  <official_title>Laryngeal Adaptation for Speech and Swallowing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Deafness and Other Communication Disorders (NIDCD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will test laryngeal adaptation in speech and swallowing function in healthy&#xD;
      adults, in patients with cerebral stroke, and in patients with spinocerebellar ataxia type 6.&#xD;
      The findings from this proposal will be the first step toward implementing rehabilitation&#xD;
      techniques that help patients to prevent speech and swallowing errors before they occur.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    IRB Closure&#xD;
  </why_stopped>
  <start_date type="Actual">August 24, 2018</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>A cross-sectional study design will be used to examine laryngeal adaptation across all study groups.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Laryngeal Adaptation in Speech</measure>
    <time_frame>Day 1</time_frame>
    <description>To differentiate laryngeal adaptation during speech among cerebral stroke, SCA6, and healthy controls when vocal loudness is perturbed with expiratory loading.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Laryngeal Adaptation in Swallowing</measure>
    <time_frame>Day 1</time_frame>
    <description>To differentiate laryngeal adaptation among cerebral stroke, SCA6, and healthy controls when swallowing is perturbed with neck surface electrical stimulation to restrict laryngeal elevation.</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Stroke</condition>
  <condition>Spinocerebellar Ataxia</condition>
  <condition>Cerebral Stroke</condition>
  <condition>Dysphagia</condition>
  <condition>Dysarthria</condition>
  <arm_group>
    <arm_group_label>Stroke without Dysarthria</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Examine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stroke with Dysarthria</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Examine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SCA6 without Dysarthria</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Examine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SCA6 with Dysarthria</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Examine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Age-Matched Controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Examine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intermittent Perturbation to Continuous Perturbation</intervention_name>
    <description>Manipulate the Movement Planning Period (MPP), by interrupting sensory predictions by removing e-stim during the inter-trial interval (Intermittent Perturbation), followed by a washout/de-adaptation period.</description>
    <arm_group_label>Age-Matched Controls</arm_group_label>
    <arm_group_label>SCA6 with Dysarthria</arm_group_label>
    <arm_group_label>SCA6 without Dysarthria</arm_group_label>
    <arm_group_label>Stroke with Dysarthria</arm_group_label>
    <arm_group_label>Stroke without Dysarthria</arm_group_label>
    <other_name>I to C Paradigm</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous Perturbation to Intermittent Perturbation</intervention_name>
    <description>Manipulate the Movement Planning Period (MPP), by keep sensory input about the perturbation constant by maintaining e-stim during the inter-trial interval.</description>
    <arm_group_label>Age-Matched Controls</arm_group_label>
    <arm_group_label>SCA6 with Dysarthria</arm_group_label>
    <arm_group_label>SCA6 without Dysarthria</arm_group_label>
    <arm_group_label>Stroke with Dysarthria</arm_group_label>
    <arm_group_label>Stroke without Dysarthria</arm_group_label>
    <other_name>C to I Paradigm</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patient Inclusion Criteria:&#xD;
&#xD;
        All stroke and ataxia&#xD;
&#xD;
        Ataxia&#xD;
&#xD;
          -  DNA diagnosis of SCA6 and phenotype consistent with the DNA diagnosis&#xD;
&#xD;
          -  No recessive, X-linked or mitochondrial&#xD;
&#xD;
        Stroke&#xD;
&#xD;
          -  Bilateral or unilateral middle cerebral artery (MCA) stroke&#xD;
&#xD;
          -  No structural abnormalities (i.e. nodules)&#xD;
&#xD;
          -  Dysphagia involving laryngeal dysfunction&#xD;
&#xD;
        Stroke and ataxia with speech and swallowing disorders&#xD;
&#xD;
          -  no structural abnormalities&#xD;
&#xD;
          -  dysphagia involving laryngeal dysfunction&#xD;
&#xD;
        Patient Exclusion Criteria:&#xD;
&#xD;
          -  Montreal Cognitive Assess. &lt;24&#xD;
&#xD;
          -  Moderate to severe hearing loss&#xD;
&#xD;
          -  Barium allergy&#xD;
&#xD;
          -  Other confounding speech disorder (i.e. stuttering)&#xD;
&#xD;
          -  Chemo-radiation, surgical head and neck treatment&#xD;
&#xD;
          -  Smoking Hx in the past 5 yrs or &gt;5 years at any one time&#xD;
&#xD;
          -  Twenty one years of age or older&#xD;
&#xD;
          -  Breathing disorders or diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>June 10, 2021</last_update_submitted>
  <last_update_submitted_qc>June 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>speech</keyword>
  <keyword>swallowing</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>stroke</keyword>
  <keyword>deglutition</keyword>
  <keyword>dysphagia</keyword>
  <keyword>dysarthria</keyword>
  <keyword>laryngeal</keyword>
  <keyword>ataxia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ataxia</mesh_term>
    <mesh_term>Spinocerebellar Ataxias</mesh_term>
    <mesh_term>Spinocerebellar Degenerations</mesh_term>
    <mesh_term>Dysarthria</mesh_term>
  </condition_browse>
  <!-- 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/NCT03770377
org study id: IRB201702917 -A
secondary id: R01DC016275-01A1
secondary id: OCR19032
secondary id: 5R01DC016275-02
nct id: NCT03770377
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study will test laryngeal adaptation in speech and swallowing function in healthy
      adults, in patients with cerebral stroke, and in patients with spinocerebellar ataxia type 6.
      The findings from this proposal will be the first step toward implementing rehabilitation
      techniques that help patients to prevent speech and swallowing errors before they occur.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: A cross-sectional study design will be used to examine laryngeal adaptation across all study groups.
primary purpose: Treatment
masking: None (Open Label)
measure: Laryngeal Adaptation in Speech
time frame: Day 1
description: To differentiate laryngeal adaptation during speech among cerebral stroke, SCA6, and healthy controls when vocal loudness is perturbed with expiratory loading.
measure: Laryngeal Adaptation in Swallowing
time frame: Day 1
description: To differentiate laryngeal adaptation among cerebral stroke, SCA6, and healthy controls when swallowing is perturbed with neck surface electrical stimulation to restrict laryngeal elevation.
arm group label: Stroke without Dysarthria
arm group type: Experimental
description: Examine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm.
arm group label: Stroke with Dysarthria
arm group type: Experimental
description: Examine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm.
arm group label: SCA6 without Dysarthria
arm group type: Experimental
description: Examine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm.
arm group label: SCA6 with Dysarthria
arm group type: Experimental
description: Examine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm.
arm group label: Age-Matched Controls
arm group type: Active Comparator
description: Examine laryngeal adaptation across all study groups: (1) baseline measures of speech or swallowing , (2) a clinical examination of disease/condition severity and (3) the experimental paradigm.
intervention type: Device
intervention name: Intermittent Perturbation to Continuous Perturbation
description: Manipulate the Movement Planning Period (MPP), by interrupting sensory predictions by removing e-stim during the inter-trial interval (Intermittent Perturbation), followed by a washout/de-adaptation period.
arm group label: Age-Matched Controls
arm group label: SCA6 with Dysarthria
arm group label: SCA6 without Dysarthria
arm group label: Stroke with Dysarthria
arm group label: Stroke without Dysarthria
other name: I to C Paradigm
intervention type: Device
intervention name: Continuous Perturbation to Intermittent Perturbation
description: Manipulate the Movement Planning Period (MPP), by keep sensory input about the perturbation constant by maintaining e-stim during the inter-trial interval.
arm group label: Age-Matched Controls
arm group label: SCA6 with Dysarthria
arm group label: SCA6 without Dysarthria
arm group label: Stroke with Dysarthria
arm group label: Stroke without Dysarthria
other name: C to I Paradigm
criteria: 
gender: All
minimum age: 21 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
country: United States
responsible party type: Sponsor
mesh term: Deglutition Disorders
mesh term: Stroke
mesh term: Ataxia
mesh term: Spinocerebellar Ataxias
mesh term: Spinocerebellar Degenerations
mesh term: Dysarthria