Laryngeal Adaptation for Speech and Swallowing

Sponsor

University of Florida (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03770377

Collaborator

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

Enrollment

Arms

12.2

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Spinocerebellar Ataxia Cerebral Stroke Dysphagia Dysarthria	Device: Intermittent Perturbation to Continuous Perturbation Device: Continuous Perturbation to Intermittent Perturbation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Laryngeal Adaptation for Speech and Swallowing

Actual Study Start Date :

Aug 24, 2018

Actual Primary Completion Date :

Aug 30, 2019

Actual Study Completion Date :

Aug 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Laryngeal Adaptation in Speech [Day 1]
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 [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.