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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03770377
Other study ID # IRB201702917 -A
Secondary ID R01DC016275-01A1
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


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
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