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

Study Purpose:

Individuals with th 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)

Study Type:

Interventional Trial

Study Category:

Device, Other

Study Status:

Active, currently recruiting

Phase:

Phase 0

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

Emily Plowman, Ph.D., University of Florida

Clinicaltrials.gov ID (11 digit #):

NCT02710162

Neals Affiliated?

No

Coordinating Center Contact Information

University of Florida
Raele Robison, M.S.; Lauren Tabor, M.S. / .(JavaScript must be enabled to view this email address) / 610-504-4605; 443-536-1234
.(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 how accurate different screening tools or tests are at identifying swallowing problems associated with Amyotrophic Lateral Sclerosis (ALS).

As a participant one evaluation will be performed at the University of Florida Swallowing Systems Core laboratory located at Shands Hospital, Gainesville will take place. This will take approximately two-hours. During this evaluation an videofluoroscopy (X-ray of swallowing), cough tests, tongue function test and questionnaires will be completed.

Study Sponsor:

University of Florida

Participant Duration:

Estimated Enrollment:

120

Estimated Study Start Date:

02/29/2016

Estimated Study Completion Date:

02/28/2017

Posting Last Modified Date:

11/30/2016

Date Study Added to alsconsortium.org:

05/01/2016
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    21

    Maximum Age:

    85

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?


    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).

  • Site Contact Information

    University of Florida
    Gainesville, Florida 32605
    United States