Delineating Swallowing Impairment and Decline in ALS

University of Florida

Status: Completed

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Device: Voluntary Peak Cough Flow Testing; Device: Pulmonary Function Testing; Other: Eating Assessment Tool 10; Procedure: Videofluoroscopic Swallowing Study (VFSS); Device: Iowa Oral Performance Instrument; Other: The Center for Neurologic Study Bulbar Function Scale; Drug: Capsaicin Challenge

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02962050

R01NS100859 (U.S. NIH Grant/Contract)

IRB201602098-N

Details and patient eligibility

About

The purpose of this study is to 1) evaluate the discriminant ability of simple clinical markers to detect swallowing impairment in individuals with ALS, 2) develop and validate a minimally invasive clinical screening tool for use at multidisciplinary ALS clinics, and 3) determine the natural history of swallowing impairment and decline in ALS.

Full description

This research study is being performed to determine screening tools or tests that are able to identify and track swallowing problems associated with Amyotrophic Lateral Sclerosis (ALS) over time. Also, this study will provide insight into the natural progression of swallowing impairment in persons with ALS over time.

Participants enrolled in this study will complete an evaluation at the University of Florida Aerodigestive Research Core laboratory located at Shands Hospital, Gainesville every three months. Each evaluation will take approximately 90 minutes. During these evaluations, a videofluoroscopy (X-ray of swallowing) examination, cough tests and questionnaires will be completed.

Enrollment: 109 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of probable or definite ALS

Exclusion criteria

• allergies to barium or capsaicin
• History of stroke
• Head and Neck Cancer
• Other disorder that might contribute to swallowing impairment
• Not enrolled in other research investigations that might impact swallowing
• Not pregnant

Trial design

109 participants in 1 patient group

ALS

Description:

Participants enrolled will complete the following tests: Videofluoroscopic Swallowing Study, Voluntary Peak Cough Flow Testing, lingual strength and endurance trials using the Iowa Oral Performance Instrument, reflexive cough testing, Pulmonary Function Testing; Eating Assessment Tool-10 (EAT-10), Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), and the The Center for Neurologic Study Bulbar Function Scale (CNS-BFS).

Treatment:

Device: Pulmonary Function Testing

Drug: Capsaicin Challenge

Other: The Center for Neurologic Study Bulbar Function Scale

Device: Iowa Oral Performance Instrument

Procedure: Videofluoroscopic Swallowing Study (VFSS)

Other: Eating Assessment Tool 10

Device: Voluntary Peak Cough Flow Testing