Laryngeal Adaptation for Speech and Swallowing

Not Applicable

Withdrawn

• Conditions: Dysphagia; Spinocerebellar Ataxia; Stroke; Cerebral Stroke; Dysarthria
• Interventions: Device: Intermittent Perturbation to Continuous Perturbation; Device: Continuous Perturbation to Intermittent Perturbation

• Registration Number: NCT03770377
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2018-08-24
• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-10
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-10
• Last Update Posted: 2021-06-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Stroke with Dysarthria	Intermittent Perturbation to Continuous Perturbation	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.
Stroke without Dysarthria	Intermittent Perturbation to Continuous Perturbation	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.
SCA6 without Dysarthria	Intermittent Perturbation to Continuous Perturbation	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.
SCA6 with Dysarthria	Intermittent Perturbation to Continuous Perturbation	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.
Stroke without Dysarthria	Continuous Perturbation to Intermittent Perturbation	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.
Age-Matched Controls	Intermittent Perturbation to Continuous Perturbation	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.
Stroke with Dysarthria	Continuous Perturbation to Intermittent Perturbation	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.
SCA6 without Dysarthria	Continuous Perturbation to Intermittent Perturbation	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.
SCA6 with Dysarthria	Continuous Perturbation to Intermittent Perturbation	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.
Age-Matched Controls	Continuous Perturbation to Intermittent Perturbation	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.

Primary Outcome Measures

Name	Time	Method
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.
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.