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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT02710162
• Date of registration: 29/02/2016
• Prospective Registration: Yes
• Primary sponsor: University of Florida
• Public title: Accurate Screening Tools for Dysphagia in Amyotrophic Lateral Sclerosis (ALS)
• Scientific title: Determination of Accurate Screening Tools for Dysphagia in Amyotrophic Lateral Sclerosis (ALS)
• Date of first enrolment: April 2016
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02710162
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Early Phase 1

Countries of recruitment

United States

Contacts

• Name: Emily Plowman, Ph.D.
• Affiliation: University of Florida

Key inclusion & exclusion criteria

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).



Age minimum: 21 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Device: Micro Mouth Pressure Meter

Drug: Capsaicin

Other: Communicative Effectiveness Survey

Device: Electrical Impedance Myography

Device: Iowa Oral Performance Instrument

Other: Functional Oral Intake Scale

Other: The Center for Neurologic Studies Bulbar Function Scale

Other: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised

Procedure: Pulmonary Function Testing

Other: Swallowing Related Quality of Life Questionnaire

Other: Eating Assessment Tool-10

Procedure: Videofluoroscopic Swallowing Study

Primary Outcome(s)

The IOPI will be used to measure Lingual strength and endurance [Time Frame: Baseline]

The nebulizer with cough protocol will be used to measure reflexive cough [Time Frame: Baseline]

The Penetration-aspiration scale will be used to measure swallowing function [Time Frame: Baseline]

The oral pneumatograph will be used to measure voluntary cough function [Time Frame: Baseline]

Secondary Outcome(s)

Bulbar function confirmed by the Center for Neurologic Studies Bulbar Function Scale (CNS-BFS) [Time Frame: Baseline]

Global disease progression as confirmed by the ALS Functional Rating Scale-Revised (ALSFRS-R) [Time Frame: Baseline]

Dietary intake as confirmed by Functional Oral Intake Scale (FOIS) [Time Frame: Baseline]

Participant perception of communication abilities as confirmed by Communication Effectiveness Survey [Time Frame: Baseline]

Participant perception of swallowing impairment as confirmed by Swallowing Quality of Life Questionnaire (SWAL-QOL) [Time Frame: Baseline]

Participant perception of swallowing related symptoms as confirmed by The Eating Assessment Tool 10 (EAT-10) [Time Frame: Baseline]

Secondary ID(s)

IRB201600163

Source(s) of Monetary Support

Please refer to primary and secondary sponsors