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Completed

NCT Number: NCT02962050

Delineating Swallowing Impairment and Decline in ALS

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Videofluoroscopic Swallowing Study (VFSS)

Procedure

Videofluoroscopic swallowing study will be performed to measure oropharyngeal swallowing

Other names: VFSS, X-Ray of Swallowing, Modified Barium Swallow Study

Voluntary Peak Cough Flow Testing

Device

Voluntary peak cough flow testing will be performed to determine the peak expiratory flow (PEF) and volume of air expelled (FEV1) during voluntary coughing.

IOWA ORAL PERFORMANCE INSTRUMENT

Device

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: IOPI

Capsaicin Challenge

Drug

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: Reflexive Cough Testing

Pulmonary function Testing

Device

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.

Eating Assessment Tool 10

Other

The Eating Assessment Tool-10 will be used for participant reporting of swallowing system severity.

Other names: EAT 10

The Center for Neurologic Study Bulbar Function Scale

Other

The Center for Neurologic Studies Bulbar Function Scale (CNS-BFS) will be used to report bulbar function in study participants.

Other names: CNS-BFS

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Delineating Physiologic Mechanisms of Swallowing Impairment and Decline in ALS

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Nov 11, 2016
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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