Laryngeal Adaptation for Speech and Swallowing

NCT03770377 | Withdrawn FDA Device

• 4 other identifiers: IRB201702917 -AR01DC016275-01A1OCR190325R01DC016275-02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke; Spinocerebellar Ataxia; Cerebral Stroke; Dysphagia; Dysarthria

Keywords

speech; swallowing; rehabilitation; stroke; deglutition; dysphagia; dysarthria; laryngeal; ataxia

Outcome Measures

Primary Outcomes (2)

• Laryngeal Adaptation in Speech

  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

  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

Study Arms (5)

Stroke without Dysarthria

EXPERIMENTAL

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; Device: Continuous Perturbation to Intermittent Perturbation

Stroke with Dysarthria

EXPERIMENTAL

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; Device: Continuous Perturbation to Intermittent Perturbation

SCA6 without Dysarthria

EXPERIMENTAL

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; Device: Continuous Perturbation to Intermittent Perturbation

SCA6 with Dysarthria

EXPERIMENTAL

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; Device: Continuous Perturbation to Intermittent Perturbation

Age-Matched Controls

ACTIVE COMPARATOR

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; Device: Continuous Perturbation to Intermittent Perturbation

Interventions

Intermittent Perturbation to Continuous Perturbation 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.

Also known as: I to C Paradigm

Age-Matched Controls; SCA6 with Dysarthria; SCA6 without Dysarthria; Stroke with Dysarthria; Stroke without Dysarthria

Continuous Perturbation to Intermittent Perturbation DEVICE

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

Also known as: C to I Paradigm

Age-Matched Controls; SCA6 with Dysarthria; SCA6 without Dysarthria; Stroke with Dysarthria; Stroke without Dysarthria

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• National Institutes of Health (NIH): collaborator

MeSH Terms

Conditions

Stroke; Spinocerebellar Ataxias; Deglutition Disorders; Dysarthria; Speech; Laryngeal Diseases; Ataxia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebellar Ataxia; Cerebellar Diseases; Spinocerebellar Degenerations; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Verbal Behavior; Communication; Behavior; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 10, 2018
• Study Start: August 24, 2018
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: June 15, 2021

Record last verified: 2021-06