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

University of Florida

Status and phase: Completed; Early Phase 1

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Device: Iowa Oral Performance Instrument; Other: Functional Oral Intake Scale; Other: Eating Assessment Tool-10; Device: Micro Mouth Pressure Meter; Drug: Capsaicin; Other: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised; Other: The Center for Neurologic Studies Bulbar Function Scale; Procedure: Videofluoroscopic Swallowing Study; Other: Swallowing Related Quality of Life Questionnaire; Procedure: Pulmonary Function Testing; Device: Electrical Impedance Myography; Other: Communicative Effectiveness Survey

Study type: Interventional

Funder types: Other

Identifiers

NCT02710162

IRB201600163

Details and patient eligibility

About

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.

Full description

This research study is being performed to determine how accurate different screening tools or tests are at identifying swallowing problems associated with Amyotrophic Lateral Sclerosis (ALS).

As a participant one evaluation will be performed at the University of Florida Swallowing Systems Core laboratory located at Shands Hospital, Gainesville will take place. This will take approximately two-hours. During this evaluation an videofluoroscopy (X-ray of swallowing), cough tests, tongue function test and questionnaires will be completed.

Enrollment: 21 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of probable or definite ALS

Exclusion criteria

• allergies to barium or capsaicin
• tracheotomy or mechanical ventilation
• absence of diaphragmatic pacer
• respiratory disease (COPD).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Screening

Experimental group

Description:

Participants enrolled will have the following test: Micro Mouth Pressure Meter, reflexive cough testing (with capsaicin used in blocks), lingual strength and endurance trials using the Iowa Oral Performance Instrument, Electrical Impedance Myography of the tongue, Pulmonary Function Testing, and a Videofluoroscopic Swallowing Study. In addition, the patient will complete the following surveys: Swallowing Related Quality of Life Questionnaire (SWAL-QOL), Eating Assessment Tool-10 (EAT-10), Functional Oral Intake Scale (FOIS), Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), The Center for Neurologic Studies Bulbar Function Scale (CNS-BFS), and the Communicative Effectiveness Survey (CES).

Treatment:

Other: Communicative Effectiveness Survey

Device: Micro Mouth Pressure Meter

Other: Eating Assessment Tool-10

Device: Electrical Impedance Myography

Other: Swallowing Related Quality of Life Questionnaire

Procedure: Pulmonary Function Testing

Other: The Center for Neurologic Studies Bulbar Function Scale

Procedure: Videofluoroscopic Swallowing Study

Other: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised

Other: Functional Oral Intake Scale

Drug: Capsaicin

Device: Iowa Oral Performance Instrument