Laryngeal Adaptation for Speech and Swallowing

June 10, 2021 updated by: University of Florida
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Stroke without Dysarthria
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.
Device: Intermittent Perturbation to Continuous Perturbation
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.
Other Names:
  • I to C Paradigm
Device: Continuous Perturbation to Intermittent Perturbation
Manipulate the Movement Planning Period (MPP), by keep sensory input about the perturbation constant by maintaining e-stim during the inter-trial interval.
Other Names:
  • C to I Paradigm
EXPERIMENTAL: Stroke with Dysarthria
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.
Device: Intermittent Perturbation to Continuous Perturbation
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.
Other Names:
  • I to C Paradigm
Device: Continuous Perturbation to Intermittent Perturbation
Manipulate the Movement Planning Period (MPP), by keep sensory input about the perturbation constant by maintaining e-stim during the inter-trial interval.
Other Names:
  • C to I Paradigm
EXPERIMENTAL: SCA6 without Dysarthria
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.
Device: Intermittent Perturbation to Continuous Perturbation
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.
Other Names:
  • I to C Paradigm
Device: Continuous Perturbation to Intermittent Perturbation
Manipulate the Movement Planning Period (MPP), by keep sensory input about the perturbation constant by maintaining e-stim during the inter-trial interval.
Other Names:
  • C to I Paradigm
EXPERIMENTAL: SCA6 with Dysarthria
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.
Device: Intermittent Perturbation to Continuous Perturbation
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.
Other Names:
  • I to C Paradigm
Device: Continuous Perturbation to Intermittent Perturbation
Manipulate the Movement Planning Period (MPP), by keep sensory input about the perturbation constant by maintaining e-stim during the inter-trial interval.
Other Names:
  • C to I Paradigm
ACTIVE_COMPARATOR: Age-Matched Controls
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.
Device: Intermittent Perturbation to Continuous Perturbation
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.
Other Names:
  • I to C Paradigm
Device: Continuous Perturbation to Intermittent Perturbation
Manipulate the Movement Planning Period (MPP), by keep sensory input about the perturbation constant by maintaining e-stim during the inter-trial interval.
Other Names:
  • C to I Paradigm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Laryngeal Adaptation in Speech
Time Frame: Day 1
To differentiate laryngeal adaptation during speech among cerebral stroke, SCA6, and healthy controls when vocal loudness is perturbed with expiratory loading.
Day 1
Laryngeal Adaptation in Swallowing
Time Frame: Day 1
To differentiate laryngeal adaptation among cerebral stroke, SCA6, and healthy controls when swallowing is perturbed with neck surface electrical stimulation to restrict laryngeal elevation.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 24, 2018

Primary Completion (ACTUAL)

August 30, 2019

Study Completion (ACTUAL)

August 30, 2019

Study Registration Dates

First Submitted

November 29, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (ACTUAL)

December 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 15, 2021

Last Update Submitted That Met QC Criteria

June 10, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201702917 -A
  • R01DC016275-01A1 (NIH)
  • OCR19032 (OTHER: UF ID)
  • 5R01DC016275-02 (NIH)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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