Delineating Swallowing Impairment and Decline in ALS

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

Interventions

PROCEDURE

Videofluoroscopic Swallowing Study (VFSS)

Videofluoroscopic swallowing study will be performed to measure oropharyngeal swallowing

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.

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.

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

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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• University of Florida

  lead OTHER

Principal Investigators

• Emily Plowman, PhD · University of Florida

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-31

Primary Completion

2023-02-16

Completion

2023-02-16

FDA Drug

Yes

Countries

• United States

Study Locations