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Laryngeal Adaptation for Speech and Swallowing

Primary Purpose

Stroke, Spinocerebellar Ataxia, Cerebral Stroke

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intermittent Perturbation to Continuous Perturbation
Continuous Perturbation to Intermittent Perturbation
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring speech, swallowing, rehabilitation, stroke, deglutition, dysphagia, dysarthria, laryngeal, ataxia

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Patient Inclusion Criteria:

All stroke and ataxia

Ataxia

  • DNA diagnosis of SCA6 and phenotype consistent with the DNA diagnosis
  • No recessive, X-linked or mitochondrial

Stroke

  • Bilateral or unilateral middle cerebral artery (MCA) stroke
  • No structural abnormalities (i.e. nodules)
  • Dysphagia involving laryngeal dysfunction

Stroke and ataxia with speech and swallowing disorders

  • no structural abnormalities
  • dysphagia involving laryngeal dysfunction

Patient Exclusion Criteria:

  • Montreal Cognitive Assess. <24
  • Moderate to severe hearing loss
  • Barium allergy
  • Other confounding speech disorder (i.e. stuttering)
  • Chemo-radiation, surgical head and neck treatment
  • Smoking Hx in the past 5 yrs or >5 years at any one time
  • Twenty one years of age or older
  • Breathing disorders or diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Stroke without Dysarthria

    Stroke with Dysarthria

    SCA6 without Dysarthria

    SCA6 with Dysarthria

    Age-Matched Controls

    Arm 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.

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Laryngeal Adaptation in Speech
    To differentiate laryngeal adaptation during speech among cerebral stroke, SCA6, and healthy controls when vocal loudness is perturbed with expiratory loading.
    Laryngeal Adaptation in Swallowing
    To differentiate laryngeal adaptation among cerebral stroke, SCA6, and healthy controls when swallowing is perturbed with neck surface electrical stimulation to restrict laryngeal elevation.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 29, 2018
    Last Updated
    June 10, 2021
    Sponsor
    University of Florida
    Collaborators
    National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03770377
    Brief Title
    Laryngeal Adaptation for Speech and Swallowing
    Official Title
    Laryngeal Adaptation for Speech and Swallowing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    IRB Closure
    Study Start Date
    August 24, 2018 (Actual)
    Primary Completion Date
    August 30, 2019 (Actual)
    Study Completion Date
    August 30, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Florida
    Collaborators
    National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Spinocerebellar Ataxia, Cerebral Stroke, Dysphagia, Dysarthria
    Keywords
    speech, swallowing, rehabilitation, stroke, deglutition, dysphagia, dysarthria, laryngeal, ataxia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    A cross-sectional study design will be used to examine laryngeal adaptation across all study groups.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Stroke without Dysarthria
    Arm Type
    Experimental
    Arm 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 Title
    Stroke with Dysarthria
    Arm Type
    Experimental
    Arm 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 Title
    SCA6 without Dysarthria
    Arm Type
    Experimental
    Arm 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 Title
    SCA6 with Dysarthria
    Arm Type
    Experimental
    Arm 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 Title
    Age-Matched Controls
    Arm Type
    Active Comparator
    Arm 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(s)
    Intermittent Perturbation to Continuous Perturbation
    Other Intervention Name(s)
    I to C Paradigm
    Intervention 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.
    Intervention Type
    Device
    Intervention Name(s)
    Continuous Perturbation to Intermittent Perturbation
    Other Intervention Name(s)
    C to I Paradigm
    Intervention Description
    Manipulate the Movement Planning Period (MPP), by keep sensory input about the perturbation constant by maintaining e-stim during the inter-trial interval.
    Primary Outcome Measure Information:
    Title
    Laryngeal Adaptation in Speech
    Description
    To differentiate laryngeal adaptation during speech among cerebral stroke, SCA6, and healthy controls when vocal loudness is perturbed with expiratory loading.
    Time Frame
    Day 1
    Title
    Laryngeal Adaptation in Swallowing
    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.
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Patient Inclusion Criteria: All stroke and ataxia Ataxia DNA diagnosis of SCA6 and phenotype consistent with the DNA diagnosis No recessive, X-linked or mitochondrial Stroke Bilateral or unilateral middle cerebral artery (MCA) stroke No structural abnormalities (i.e. nodules) Dysphagia involving laryngeal dysfunction Stroke and ataxia with speech and swallowing disorders no structural abnormalities dysphagia involving laryngeal dysfunction Patient Exclusion Criteria: Montreal Cognitive Assess. <24 Moderate to severe hearing loss Barium allergy Other confounding speech disorder (i.e. stuttering) Chemo-radiation, surgical head and neck treatment Smoking Hx in the past 5 yrs or >5 years at any one time Twenty one years of age or older Breathing disorders or diseases

    12. IPD Sharing Statement

    Learn more about this trial

    Laryngeal Adaptation for Speech and Swallowing

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