Delineating Swallowing Impairment and Decline in ALS
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| ClinicalTrials.gov Identifier: NCT02962050 |
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Recruitment Status :
Active, not recruiting
First Posted : November 11, 2016
Last Update Posted : January 20, 2023
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Sponsor:
University of Florida
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Florida
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Brief Summary:
The purpose of this study is to 1) evaluate the discriminant ability of simple clinical markers to detect swallowing impairment in individuals with ALS, 2) develop and validate a minimally invasive clinical screening tool for use at multidisciplinary ALS clinics, and 3) determine the natural history of swallowing impairment and decline in ALS.
| Condition or disease | Intervention/treatment |
|---|---|
| Amyotrophic Lateral Sclerosis | Procedure: Videofluoroscopic Swallowing Study (VFSS) Device: Voluntary Peak Cough Flow Testing Device: Iowa Oral Performance Instrument Drug: Capsaicin Challenge Device: Pulmonary Function Testing Other: Eating Assessment Tool 10 Other: The Center for Neurologic Study Bulbar Function Scale |
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 : | Observational |
| Estimated Enrollment : | 280 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Delineating Physiologic Mechanisms of Swallowing Impairment and Decline in ALS |
| Actual Study Start Date : | May 31, 2017 |
| Estimated Primary Completion Date : | March 31, 2023 |
| Estimated Study Completion Date : | March 31, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Amyotrophic lateral sclerosis
Juvenile primary lateral sclerosis
MedlinePlus related topics:
Amyotrophic Lateral Sclerosis
| 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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Procedure: Videofluoroscopic Swallowing Study (VFSS)
Videofluoroscopic swallowing study will be performed to measure oropharyngeal swallowing
Other Names:
Device: Voluntary Peak Cough Flow Testing Voluntary peak cough flow testing will be performed to determine the peak expiratory flow (PEF) and volume of air expelled (FEV1) during voluntary coughing. Device: Iowa Oral Performance Instrument 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 Name: IOPI Drug: Capsaicin Challenge 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 Name: Reflexive Cough Testing Device: Pulmonary Function Testing 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. Other: Eating Assessment Tool 10 The Eating Assessment Tool-10 will be used for participant reporting of swallowing system severity.
Other Name: EAT 10 Other: The Center for Neurologic Study Bulbar Function Scale The Center for Neurologic Studies Bulbar Function Scale (CNS-BFS) will be used to report bulbar function in study participants.
Other Name: CNS-BFS |
Primary Outcome Measures :
- Global Swallowing Function [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]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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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Individuals with Amyotrophic Lateral Sclerosis
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962050
Locations
| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32605 | |
| University of South Florida | |
| Tampa, Florida, United States, 33620 | |
Sponsors and Collaborators
University of Florida
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
| Principal Investigator: | Emily Plowman, PhD | University of Florida |
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT02962050 |
| Other Study ID Numbers: |
IRB201602098-N R01NS100859 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 11, 2016 Key Record Dates |
| Last Update Posted: | January 20, 2023 |
| Last Verified: | January 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Motor Neuron Disease Amyotrophic Lateral Sclerosis Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies |
Proteostasis Deficiencies Metabolic Diseases Capsaicin Antipruritics Dermatologic Agents Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |