- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02962050
Delineating Swallowing Impairment and Decline in ALS
Delineating Physiologic Mechanisms of Swallowing Impairment and Decline in ALS
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This research study is being performed to determine screening tools or tests that are able to identify and track swallowing problems associated with Amyotrophic Lateral Sclerosis (ALS) over time. Also, this study will provide insight into the natural progression of swallowing impairment in persons with ALS over time.
Participants enrolled in this study will complete an evaluation at the University of Florida Aerodigestive Research Core laboratory located at Shands Hospital, Gainesville every three months. Each evaluation will take approximately 90 minutes. During these evaluations, a videofluoroscopy (X-ray of swallowing) examination, cough tests and questionnaires will be completed.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Florida
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Gainesville, Florida, United States, 32605
- University of Florida
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Tampa, Florida, United States, 33620
- University of South Florida
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- diagnosis of probable or definite ALS
Exclusion Criteria:
- allergies to barium or capsaicin
- History of stroke
- Head and Neck Cancer
- Other disorder that might contribute to swallowing impairment
- Not enrolled in other research investigations that might impact swallowing
- Not pregnant
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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ALS
Participants enrolled will complete the following tests: Videofluoroscopic Swallowing Study, Voluntary Peak Cough Flow Testing, lingual strength and endurance trials using the Iowa Oral Performance Instrument, reflexive cough testing, Pulmonary Function Testing; Eating Assessment Tool-10 (EAT-10), Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), and the The Center for Neurologic Study Bulbar Function Scale (CNS-BFS).
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The Iowa Oral Performance Instrument (IOPI) is a device that measures the peak pressure performance of lingual strength and endurance via the action of a bulb placed on the hard palate.
Other Names:
Videofluoroscopic swallowing study will be performed to measure oropharyngeal swallowing
Other Names:
Voluntary peak cough flow testing will be performed to determine the peak expiratory flow (PEF) and volume of air expelled (FEV1) during voluntary coughing.
A capsaicin challenge with three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin.
The capsaicin will be dissolved in a vehicle solution consisting of 80% physiological saline, and 20% ethanol.
Participants will be given the instruction "cough if you need to" prior to capsaicin delivery.The solution will be administered automatically upon detection of an inspired breath and there will be a minimum of one minute between each trial.
This is to test the reflexive cough testing for upper airway sensitivity and motor thresholds.
Other Names:
Pulmonary Function testing will be performed using conventional methods and will include the following outcomes: forced vital capacity (FVC), maximum inspiratory pressure (MIP), and maximum expiratory pressure (MEP) expressed as a percentage of predicted values.
The Eating Assessment Tool-10 will be used for participant reporting of swallowing system severity.
Other Names:
The Center for Neurologic Studies Bulbar Function Scale (CNS-BFS) will be used to report bulbar function in study participants.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global Swallowing Function
Time Frame: Baseline, every 3 months through study completion, an average of 2 years.
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The DIGEST scale will be used by trained, blinded raters to assign ratings of safety to bolus trials.
Both efficiency and safety will be assigned a score from 0-4 (more safe/efficient - less safe/efficient) and based on these ratings, will be given a total score ranging from 0-4 that captures their DIGEST rating.
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Baseline, every 3 months through study completion, an average of 2 years.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emily Plowman, PhD, University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Spinal Cord Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Motor Neuron Disease
- Amyotrophic Lateral Sclerosis
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Dermatologic Agents
- Antipruritics
- Capsaicin
Other Study ID Numbers
- IRB201602098-N
- R01NS100859 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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