Laryngeal Adaptation for Speech and Swallowing

Stroke Clinical Trial

Official title:

Laryngeal Adaptation for Speech and Swallowing

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03770377
• Other study ID #: IRB201702917 -A
• Secondary ID: R01DC016275-01A1
• Status: Withdrawn
• Phase: N/A
• Start date: August 24, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: June 2021
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Ataxia
• Cerebral Stroke
• Deglutition Disorders
• Dysarthria
• Dysphagia
• Spinocerebellar Ataxia
• Spinocerebellar Ataxias
• Spinocerebellar Degenerations
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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