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:
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.
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