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

Early Phase 1

Completed

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

• Registration Number: NCT02710162
• Lead Sponsor: University of Florida

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-02-29
• Study First Submitted QC: 2016-03-10
• Study First Posted: 2016-03-16
• Study Start: 2016-04
• Status Verified: 2017-12
• Primary Completion: 2017-12-19
• Study Completion: 2017-12-19
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening	Videofluoroscopic Swallowing Study	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).
Screening	Functional Oral Intake Scale	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).
Screening	Electrical Impedance Myography	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).
Screening	Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised	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).
Screening	Eating Assessment Tool-10	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).
Screening	Iowa Oral Performance Instrument	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).
Screening	Pulmonary Function Testing	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).
Screening	The Center for Neurologic Studies Bulbar Function Scale	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).
Screening	Micro Mouth Pressure Meter	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).
Screening	Swallowing Related Quality of Life Questionnaire	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).
Screening	Communicative Effectiveness Survey	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).
Screening	Capsaicin	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).

Primary Outcome Measures

Name	Time	Method
The nebulizer with cough protocol will be used to measure reflexive cough	Baseline	Reflexive cough will be assessed using an oral pneumotachograph, differential pressure transducer, and have a side port with a one-way inspiratory valve for nebulizer connection. The nebulizer will deliver three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin.
The oral pneumatograph will be used to measure voluntary cough function	Baseline	Voluntary cough function will be assessed using an oral pneumotachograph, connected to a spirometer filter during voluntary cough production. The participant will be seated with a respiratory face-mask held in place by the examiner and instructed to complete three tidal breaths into the face-mask, airflow signal will be measured
The Penetration-aspiration scale will be used to measure swallowing function	Baseline
The IOPI will be used to measure Lingual strength and endurance	Baseline	The Iowa Oral Pressure Instrument device will measure the peak performance of lingual strength a via the action of a bulb placed on the hard palate. To assess maximum anterior isometric pressure, the bulb will be placed on the roof of the mouth and the participant will raise his or her tongue to apply pressure to this bulb and then quickly release the tongue back into a neutral position. This repetitive tongue movement will be performed three times and values will be recorded.

Secondary Outcome Measures

Name	Time	Method
Participant perception of swallowing impairment as confirmed by Swallowing Quality of Life Questionnaire (SWAL-QOL)	Baseline	SWAL-QOL is a standardized psychometric scale measuring swallow-related QOL and containing 44-items relating to swallowing specific quality of life measured across 10 domains. Individual domain scores and a total SWAL-QOL score will be derived. Scores range from 0 to 100, with a score of 100 representing no impairment (the most favorable state)
Dietary intake as confirmed by Functional Oral Intake Scale (FOIS)	Baseline	FOIS is a validated 7-point scale indexing an individual's ability to intake food on a day-to-day basis.; TUBE DEPENDENT (levels 1-3); 1. No oral intake; 2. Tube dependent with minimal/inconsistent oral intake; 3. Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7); 4. Total oral intake of a single consistency; 5. Total oral intake of multiple consistencies requiring special preparation; 6. Total oral intake with no special preparation, but must avoid specific foods or liquid items; 7. Total oral intake with no restrictions
Participant perception of swallowing related symptoms as confirmed by The Eating Assessment Tool 10 (EAT-10)	Baseline	EAT-10 is a 10-item validated self-administered dysphagia severity symptom survey. Score is 0 - 40 with 0 being the best possible score and 40 the worst possible score.
Participant perception of communication abilities as confirmed by Communication Effectiveness Survey	Baseline	A measure of self-rated communication abilities across a variety of settings as perceived by the patients and/or their caregivers will be measured using the 8-point Communication Effectiveness Survey (CES)
Global disease progression as confirmed by the ALS Functional Rating Scale-Revised (ALSFRS-R)	Baseline	The ALSFRS-R includes 12 questions. Each task is rated on a five-point scale from 0 = can't do, to 4 = normal ability. Individual item scores are summed to produce a reported score of between 0=worst and 48=best.
Bulbar function confirmed by the Center for Neurologic Studies Bulbar Function Scale (CNS-BFS)	Baseline

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States