Laryngeal Adaptation for Speech and Swallowing

NCT ID: NCT03770377

Last Updated: 2021-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-24

Study Completion Date

2019-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Spinocerebellar Ataxia Cerebral Stroke Dysphagia Dysarthria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A cross-sectional study design will be used to examine laryngeal adaptation across all study groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Intermittent Perturbation to Continuous Perturbation

Intervention Type DEVICE

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.

Continuous Perturbation to Intermittent Perturbation

Intervention Type DEVICE

Manipulate the Movement Planning Period (MPP), by keep sensory input about the perturbation constant by maintaining e-stim during the inter-trial interval.

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.

Group Type EXPERIMENTAL

Intermittent Perturbation to Continuous Perturbation

Intervention Type DEVICE

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.

Continuous Perturbation to Intermittent Perturbation

Intervention Type DEVICE

Manipulate the Movement Planning Period (MPP), by keep sensory input about the perturbation constant by maintaining e-stim during the inter-trial interval.

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.

Group Type EXPERIMENTAL

Intermittent Perturbation to Continuous Perturbation

Intervention Type DEVICE

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.

Continuous Perturbation to Intermittent Perturbation

Intervention Type DEVICE

Manipulate the Movement Planning Period (MPP), by keep sensory input about the perturbation constant by maintaining e-stim during the inter-trial interval.

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.

Group Type EXPERIMENTAL

Intermittent Perturbation to Continuous Perturbation

Intervention Type DEVICE

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.

Continuous Perturbation to Intermittent Perturbation

Intervention Type DEVICE

Manipulate the Movement Planning Period (MPP), by keep sensory input about the perturbation constant by maintaining e-stim during the inter-trial interval.

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.

Group Type ACTIVE_COMPARATOR

Intermittent Perturbation to Continuous Perturbation

Intervention Type DEVICE

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.

Continuous Perturbation to Intermittent Perturbation

Intervention Type DEVICE

Manipulate the Movement Planning Period (MPP), by keep sensory input about the perturbation constant by maintaining e-stim during the inter-trial interval.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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I to C Paradigm C to I Paradigm

Eligibility Criteria

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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

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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R01DC016275-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OCR19032

Identifier Type: OTHER

Identifier Source: secondary_id

5R01DC016275-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201702917 -A

Identifier Type: -

Identifier Source: org_study_id

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