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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02710162
• Other study ID #: IRB201600163
• Status: Completed
• Phase: Early Phase 1
• First received: February 29, 2016
• Last updated: December 19, 2017
• Start date: April 2016
• Est. completion date: December 19, 2017

Study information

• Verified date: December 2017
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 19, 2017
• Est. primary completion date: December 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

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.
• 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.
• 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.

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.
• 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.
• Functional Oral Intake Scale
The Functional Oral Intake Scale (FOIS) will be used for participants to report their food intake habits.
• 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.
• Eating Assessment Tool-10
The Eating Assessment Tool-10 will be used for participant reporting of swallowing system severity.
• Communicative Effectiveness Survey
The Communication Effectiveness Survey (CES) will be used for participant reporting of communication abilities across different speech contexts.
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Penetration-aspiration scale will be used to measure swallowing function		Baseline
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Bulbar function confirmed by the Center for Neurologic Studies Bulbar Function Scale (CNS-BFS)		Baseline