Delineating Swallowing Impairment and Decline in ALS

NCT02962050 | Completed FDA Drug

• 2 other identifiers: IRB201602098-NR01NS100859
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 2

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.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Global Swallowing Function

  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.

  Baseline, every 3 months through study completion, an average of 2 years.

Study Arms (1)

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); 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

Interventions

Videofluoroscopic Swallowing Study (VFSS) PROCEDURE

Videofluoroscopic swallowing study will be performed to measure oropharyngeal swallowing

Also known as: VFSS, X-Ray of Swallowing, Modified Barium Swallow Study

ALS

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.

ALS

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.

Also known as: IOPI

ALS

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.

Also known as: Reflexive Cough Testing

ALS

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.

ALS

Eating Assessment Tool 10 OTHER

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

Also known as: EAT 10

ALS

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.

Also known as: CNS-BFS

ALS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with Amyotrophic Lateral Sclerosis

You may qualify if:

• diagnosis of probable or definite ALS

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

University of Florida

Gainesville, Florida, 32605, United States

Location

University of South Florida

Tampa, Florida, 33620, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Emily Plowman, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 11, 2016
• Study Start: May 31, 2017
• Primary Completion: February 16, 2023
• Study Completion: February 16, 2023
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

US (2)