Accurate Screening Tools for Dysphagia in Amyotrophic Lateral Sclerosis (ALS)

Summary

Individuals with th Amyotrophic Lateral Sclerosis are at high risk for swallowing impairment (dysphagia) which leads to malnutrition, decreased pulmonary health, aspiration and aspiration pneumonia. These sequelae necessitate timely identification of at risk individuals to ensure optimal management of oral intake and pulmonary function. The purpose of this study is to evaluate the discriminant ability of several non-invasive screening tools at detecting swallowing impairment in individuals with ALS.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

DRUG

Capsaicin

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.

PROCEDURE

Videofluoroscopic Swallowing Study

Videofluoroscopic swallowing study will be performed to measure the oropharyngeal swallowing.

PROCEDURE

Pulmonary Function Testing

Pulmonary Function testing will be performed using conventional methods and will include the following outcomes: forced vital capacity (FVC), sniff nasal inspiratory pressure (SNIP), peak expiratory flow (PEF), forced expiratory volume (FEV1) expressed as a percentage of predicted values.

OTHER

Swallowing Related Quality of Life Questionnaire

Swallowing Quality of Life Questionnaire (SWAL-QOL) will be used for participant reporting of swallow-related quality of life.

OTHER

Functional Oral Intake Scale

The Functional Oral Intake Scale (FOIS) will be used for participants to report their food intake habits.

OTHER

Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised

The Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) will be used to track global disease progression in participants.

OTHER

Eating Assessment Tool-10

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

OTHER

Communicative Effectiveness Survey

The Communication Effectiveness Survey (CES) will be used for participant reporting of communication abilities across different speech contexts.

OTHER

The Center for Neurologic Studies Bulbar Function Scale

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

DEVICE

Micro Mouth Pressure Meter

The participant will be seated with the nose occluded using a nose clip. After inhaling to total lung capacity, the participant will place his or her lips around the mouthpiece and blow out as forcefully as possible. A flanged rubber mouthpiece will be used to overcome the inability of some individuals to create tight lip seal due to facial muscle weakness. Three trials will be performed and the patients highest maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) used.

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.

DEVICE

Electrical Impedance Myography

The SFB7 Bioimpedance device measures the function of the tongue by calculating measures of reactance, resistance and phase once a custom electrode array is placed on the midline of the subject's tongue for approximately 2 seconds.

Sponsors & Collaborators

• University of Florida

  lead OTHER

Principal Investigators

• Emily Plowman, Ph.D. · University of Florida

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2017-12-19

Completion

2017-12-19

Countries

• United States

Study Locations