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Delineating Physiologic Mechanisms of Swallowing Impairment and Decline in ALS

Study Purpose:

Individuals with 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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Observational Study

Study Category:

Device , 

Study Status:

Enrolling

Phase:

Not Applicable

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

Emily Plowman, PhD, University of Florida

Clinicaltrials.gov ID (11 digit #):

NCT02962050

Neals Affiliated?

No

Coordinating Center Contact Information

University of Florida
Lauren DiBiase, MS / .(JavaScript must be enabled to view this email address) / 352-273-8632
.(JavaScript must be enabled to view this email address) 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 one evaluation at the University of Florida Swallowing Systems 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, tongue function test and questionnaires will be completed.

Study Sponsor:

University of Florida

Participant Duration:

Estimated Enrollment:

110

Estimated Study Start Date:

05/31/2017

Estimated Study Completion Date:

06/30/2024

Posting Last Modified Date:

01/27/2020

Date Study Added to alsconsortium.org:

02/24/2017
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    90

    Time since Symptom Onset:

    Time since Diagnosis:

    <12 months

    Can participants use Riluzole?


    Inclusion Criteria:

    diagnosis of probable or definite ALS
    diagnosis within 120 days

    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

  • Site Contact Information

    University of Florida
    Lauren DiBiase, MS / .(JavaScript must be enabled to view this email address) / 352-273-8632
    Gainesville, Florida 32605
    United States

    University of Florida College of Medicine
    Jacksonville , Florida 32209
    United States

    University of South Florida
    Tampa, Florida 33620
    United States