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

NCT02710162 | Completed Early Phase 1

• 1 other identifier: IRB201600163
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Global disease progression as confirmed by the ALS Functional Rating Scale-Revised (ALSFRS-R)

  Baseline

• Participant perception of swallowing impairment as confirmed by Swallowing Quality of Life Questionnaire (SWAL-QOL)

  Baseline

• Dietary intake as confirmed by Functional Oral Intake Scale (FOIS)

  Baseline

• Participant perception of swallowing related symptoms as confirmed by The Eating Assessment Tool 10 (EAT-10)

  Baseline

• Participant perception of communication abilities as confirmed by Communication Effectiveness Survey

  Baseline

Study Arms (1)

Screening

EXPERIMENTAL

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; 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

Interventions

Micro Mouth Pressure Meter DEVICE

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.

Also known as: digital manometer, Micro medical device

Screening

Iowa Oral Performance Instrument DEVICE

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.

Also known as: IOPI

Screening

Electrical Impedance Myography DEVICE

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.

Also known as: EIM

Screening

Capsaicin DRUG

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.

Also known as: Hot pepper

Screening

Videofluoroscopic Swallowing Study PROCEDURE

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

Also known as: VFSS, modified barium swallow (MBS), X-Ray of swallowing

Screening

Pulmonary Function Testing PROCEDURE

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.

Screening

Swallowing Related Quality of Life Questionnaire OTHER

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

Also known as: SWAL-QOL

Screening

Functional Oral Intake Scale OTHER

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

Also known as: FOIS

Screening

Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised OTHER

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

Also known as: ALSFRS-R

Screening

Eating Assessment Tool-10 OTHER

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

Also known as: EAT-10

Screening

Communicative Effectiveness Survey OTHER

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

Also known as: CES

Screening

The Center for Neurologic Studies Bulbar Function Scale OTHER

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

Also known as: CNS-BFS

Screening

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of probable or definite ALS

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32605, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Capsaicin; Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Emily Plowman, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 16, 2016
• Study Start: April 1, 2016
• Primary Completion: December 19, 2017
• Study Completion: December 19, 2017
• Last Updated: December 21, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)