Laryngeal Adaptation for Speech and Swallowing

University of Florida

Status: Withdrawn

Conditions: Dysphagia; Stroke; Spinocerebellar Ataxia; Dysarthria; Cerebral Stroke

Treatments: Device: Continuous Perturbation to Intermittent Perturbation; Device: Intermittent Perturbation to Continuous Perturbation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03770377

R01DC016275-01A1 (U.S. NIH Grant/Contract)

IRB201702917 -A

5R01DC016275-02 (U.S. NIH Grant/Contract)

OCR19032 (Other Identifier)

Details and patient eligibility

About

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.

Sex: All

Ages: 21 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 5 patient groups

Stroke without Dysarthria

Experimental group

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.

Treatment:

Device: Intermittent Perturbation to Continuous Perturbation

Device: Continuous Perturbation to Intermittent Perturbation

Stroke with Dysarthria

Experimental group

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.

Treatment:

Device: Intermittent Perturbation to Continuous Perturbation

Device: Continuous Perturbation to Intermittent Perturbation

SCA6 without Dysarthria

Experimental group

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.

Treatment:

Device: Intermittent Perturbation to Continuous Perturbation

Device: Continuous Perturbation to Intermittent Perturbation

SCA6 with Dysarthria

Experimental group

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.

Treatment:

Device: Intermittent Perturbation to Continuous Perturbation

Device: Continuous Perturbation to Intermittent Perturbation

Age-Matched Controls

Active Comparator group

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.

Treatment:

Device: Intermittent Perturbation to Continuous Perturbation

Device: Continuous Perturbation to Intermittent Perturbation