Delineating Swallowing Impairment and Decline in ALS
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Observational

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): Videofluoroscopic Swallowing Study (VFSS); Voluntary Peak Cough Flow Testing; Iowa Oral Performance Instrument; Capsaicin Challenge; Pulmonary Function Testing; Eating Assessment Tool 10; The Center for Neurologic Study Bulbar Function Scale
Intervention type(s): Procedure; Device; Device; Drug; Device; Other; Other
Intervention description(s): Videofluoroscopic swallowing study will be performed to measure oropharyngeal swallowing; Voluntary peak cough flow testing will be performed to determine the peak expiratory flow (PEF) and volume of air expelled (FEV1) during voluntary coughing.; The Iowa Oral Performance Instrument (IOPI) is a device that measures the peak pressure performance of lingual strength and endurance via the action of a bulb placed on the hard palate.; A capsaicin challenge with three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin. The capsaicin will be dissolved in a vehicle solution consisting of 80% physiological saline, and 20% ethanol. Participants will be given the instruction "cough if you need to" prior to capsaicin delivery.The solution will be administered automatically upon detection of an inspired breath and there will be a minimum of one minute between each trial. This is to test the reflexive cough testing for upper airway sensitivity and motor thresholds.; Pulmonary Function testing will be performed using conventional methods and will include the following outcomes: forced vital capacity (FVC), maximum inspiratory pressure (MIP), and maximum expiratory pressure (MEP) expressed as a percentage of predicted values.; The Eating Assessment Tool-10 will be used for participant reporting of swallowing system severity.; The Center for Neurologic Studies Bulbar Function Scale (CNS-BFS) will be used to report bulbar function in study participants.
Other intervention name(s): VFSS; X-Ray of Swallowing; Modified Barium Swallow Study; IOPI; Reflexive Cough Testing; EAT 10; CNS-BFS
Intervention MeSH terms: Capsaicin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals with Amyotrophic Lateral Sclerosis