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Delineating Swallowing Impairment and Decline in ALS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02962050
Recruitment Status : Active, not recruiting
First Posted : November 11, 2016
Last Update Posted : January 20, 2023
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Florida

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

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.

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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


Group/Cohort Intervention/treatment
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).
Procedure: Videofluoroscopic Swallowing Study (VFSS)
Videofluoroscopic swallowing study will be performed to measure oropharyngeal swallowing
Other Names:
  • VFSS
  • X-Ray of Swallowing
  • Modified Barium Swallow Study

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 :
  1. 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.



Information from the National Library of Medicine

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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
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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
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Principal Investigator: Emily Plowman, PhD University of Florida
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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

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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