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

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

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.

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32605
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Screening; 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).

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.; Other Names: digital manometer; Micro medical device; 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.; Other Names: IOPI; 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.; Other Names: EIM; 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.; Other Names: Hot pepper; Procedure: Videofluoroscopic Swallowing Study; Videofluoroscopic swallowing study will be performed to measure the oropharyngeal swallowing.; Other Names: VFSS; modified barium swallow (MBS); X-Ray of 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 Names: SWAL-QOL; Other: Functional Oral Intake Scale; The Functional Oral Intake Scale (FOIS) will be used for participants to report their food intake habits.; Other Names: FOIS; 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 Names: ALSFRS-R; Other: Eating Assessment Tool-10; The Eating Assessment Tool-10 will be used for participant reporting of swallowing system severity.; Other Names: EAT-10; Other: Communicative Effectiveness Survey; The Communication Effectiveness Survey (CES) will be used for participant reporting of communication abilities across different speech contexts.; Other Names: CES; 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.; Other Names: CNS-BFS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Penetration-aspiration scale will be used to measure swallowing function		Baseline
The IOPI will be used to measure Lingual strength and endurance	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.	Baseline
The oral pneumatograph will be used to measure voluntary cough function	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	Baseline
The nebulizer with cough protocol will be used to measure reflexive cough	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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global disease progression as confirmed by the ALS Functional Rating Scale-Revised (ALSFRS-R)	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.	Baseline
Participant perception of swallowing impairment as confirmed by Swallowing Quality of Life Questionnaire (SWAL-QOL)	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)	Baseline
Dietary intake as confirmed by Functional Oral Intake Scale (FOIS)	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); No oral intake; Tube dependent with minimal/inconsistent oral intake; Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7); Total oral intake of a single consistency; Total oral intake of multiple consistencies requiring special preparation; Total oral intake with no special preparation, but must avoid specific foods or liquid items; Total oral intake with no restrictions	Baseline
Participant perception of swallowing related symptoms as confirmed by The Eating Assessment Tool 10 (EAT-10)	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.	Baseline
Participant perception of communication abilities as confirmed by Communication Effectiveness Survey	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)	Baseline
Bulbar function confirmed by the Center for Neurologic Studies Bulbar Function Scale (CNS-BFS)		Baseline

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Emily Plowman, Ph.D., University of Florida

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): December 19, 2017
• Study Completion (Actual): December 19, 2017

Study Registration Dates

• First Submitted: February 29, 2016
• First Submitted That Met QC Criteria: March 10, 2016
• First Posted (Estimate): March 16, 2016

Study Record Updates

• Last Update Posted (Actual): December 21, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; Antipruritics; Capsaicin
• Other Study ID Numbers: IRB201600163

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No