Delineating Physiologic Mechanisms of Swallowing Impairment and Decline in ALS

Study Purpose:

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.

Study Status:

Not recruiting

Disease:

Amyotrophic Lateral Sclerosis

Study Type:

Observational

Type of Intervention:

N/A

Intervention Name:

N/A

Placebo:

N/A

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

Emily Plowman, PhD, University of Florida

Clinicaltrials.gov ID:

NCT02962050

Neals Affiliated?

No

Coordinating Center Contact Information

University of Florida

Gainesville, Florida, 32605 United States

Full Study Summary:

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.

Study Sponsor:

University of Florida

Estimated Enrollment:

109

Estimated Study Start Date:

05 / 31 / 2017

Estimated Study Completion Date:

02 / 16 / 2023

Posting Last Modified Date:

02 / 23 / 2023

Date Study Added to neals.org:

11 / 11 / 2016

Minimum Age:

18 Years

Maximum Age:

90 Years

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

University of Florida

Gainesville, Florida 32605
United States

University of South Florida

Tampa, Florida 33620
United States