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Trial record 23 of 677 for:    amyotrophic lateral sclerosis

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

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ClinicalTrials.gov Identifier: NCT02710162
Recruitment Status : Completed
First Posted : March 16, 2016
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Device: Micro Mouth Pressure Meter Device: Iowa Oral Performance Instrument Device: Electrical Impedance Myography Drug: Capsaicin Procedure: Videofluoroscopic Swallowing Study Procedure: Pulmonary Function Testing Other: Swallowing Related Quality of Life Questionnaire Other: Functional Oral Intake Scale Other: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised Other: Eating Assessment Tool-10 Other: Communicative Effectiveness Survey Other: The Center for Neurologic Studies Bulbar Function Scale Early Phase 1

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Determination of Accurate Screening Tools for Dysphagia in Amyotrophic Lateral Sclerosis (ALS)
Study Start Date : April 2016
Actual Primary Completion Date : December 19, 2017
Actual Study Completion Date : December 19, 2017


Arm Intervention/treatment
Experimental: Screening
Participants enrolled will have the following test: Micro Mouth Pressure Meter, reflexive cough testing (with capsaicin used in blocks), lingual strength and endurance trials using the Iowa Oral Performance Instrument, Electrical Impedance Myography of the tongue, Pulmonary Function Testing, and a Videofluoroscopic Swallowing Study. In addition, the patient will complete the following surveys: Swallowing Related Quality of Life Questionnaire (SWAL-QOL), Eating Assessment Tool-10 (EAT-10), Functional Oral Intake Scale (FOIS), Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), The Center for Neurologic Studies Bulbar Function Scale (CNS-BFS), and the Communicative Effectiveness Survey (CES).
Device: Micro Mouth Pressure Meter
The participant will be seated with the nose occluded using a nose clip. After inhaling to total lung capacity, the participant will place his or her lips around the mouthpiece and blow out as forcefully as possible. A flanged rubber mouthpiece will be used to overcome the inability of some individuals to create tight lip seal due to facial muscle weakness. Three trials will be performed and the patients highest maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) used.
Other Names:
  • digital manometer
  • Micro medical device

Device: Iowa Oral Performance Instrument
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.
Other Name: IOPI

Device: Electrical Impedance Myography
The SFB7 Bioimpedance device measures the function of the tongue by calculating measures of reactance, resistance and phase once a custom electrode array is placed on the midline of the subject's tongue for approximately 2 seconds.
Other Name: EIM

Drug: Capsaicin
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.
Other Name: Hot pepper

Procedure: Videofluoroscopic Swallowing Study
Videofluoroscopic swallowing study will be performed to measure the oropharyngeal swallowing.
Other Names:
  • VFSS
  • modified barium swallow (MBS)
  • X-Ray of swallowing

Procedure: Pulmonary Function Testing
Pulmonary Function testing will be performed using conventional methods and will include the following outcomes: forced vital capacity (FVC), sniff nasal inspiratory pressure (SNIP), peak expiratory flow (PEF), forced expiratory volume (FEV1) expressed as a percentage of predicted values.

Other: Swallowing Related Quality of Life Questionnaire
Swallowing Quality of Life Questionnaire (SWAL-QOL) will be used for participant reporting of swallow-related quality of life.
Other Name: SWAL-QOL

Other: Functional Oral Intake Scale
The Functional Oral Intake Scale (FOIS) will be used for participants to report their food intake habits.
Other Name: FOIS

Other: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised
The Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) will be used to track global disease progression in participants.
Other Name: ALSFRS-R

Other: Eating Assessment Tool-10
The Eating Assessment Tool-10 will be used for participant reporting of swallowing system severity.
Other Name: EAT-10

Other: Communicative Effectiveness Survey
The Communication Effectiveness Survey (CES) will be used for participant reporting of communication abilities across different speech contexts.
Other Name: CES

Other: The Center for Neurologic Studies Bulbar Function Scale
The Center for Neurologic Studies Bulbar Function Scale (CNS-BFS) will be used to report bulbar function in study participants.
Other Name: CNS-BFS




Primary Outcome Measures :
  1. The Penetration-aspiration scale will be used to measure swallowing function [ Time Frame: Baseline ]
  2. The IOPI will be used to measure Lingual strength and endurance [ Time Frame: Baseline ]
    The Iowa Oral Pressure Instrument device will measure the peak performance of lingual strength a via the action of a bulb placed on the hard palate. To assess maximum anterior isometric pressure, the bulb will be placed on the roof of the mouth and the participant will raise his or her tongue to apply pressure to this bulb and then quickly release the tongue back into a neutral position. This repetitive tongue movement will be performed three times and values will be recorded.

  3. The oral pneumatograph will be used to measure voluntary cough function [ Time Frame: Baseline ]
    Voluntary cough function will be assessed using an oral pneumotachograph, connected to a spirometer filter during voluntary cough production. The participant will be seated with a respiratory face-mask held in place by the examiner and instructed to complete three tidal breaths into the face-mask, airflow signal will be measured

  4. The nebulizer with cough protocol will be used to measure reflexive cough [ Time Frame: Baseline ]
    Reflexive cough will be assessed using an oral pneumotachograph, differential pressure transducer, and have a side port with a one-way inspiratory valve for nebulizer connection. The nebulizer will deliver three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin.


Secondary Outcome Measures :
  1. Global disease progression as confirmed by the ALS Functional Rating Scale-Revised (ALSFRS-R) [ Time Frame: Baseline ]
    The ALSFRS-R includes 12 questions. Each task is rated on a five-point scale from 0 = can't do, to 4 = normal ability. Individual item scores are summed to produce a reported score of between 0=worst and 48=best.

  2. Participant perception of swallowing impairment as confirmed by Swallowing Quality of Life Questionnaire (SWAL-QOL) [ Time Frame: Baseline ]
    SWAL-QOL is a standardized psychometric scale measuring swallow-related QOL and containing 44-items relating to swallowing specific quality of life measured across 10 domains. Individual domain scores and a total SWAL-QOL score will be derived. Scores range from 0 to 100, with a score of 100 representing no impairment (the most favorable state)

  3. Dietary intake as confirmed by Functional Oral Intake Scale (FOIS) [ Time Frame: Baseline ]

    FOIS is a validated 7-point scale indexing an individual's ability to intake food on a day-to-day basis.

    TUBE DEPENDENT (levels 1-3)

    1. No oral intake
    2. Tube dependent with minimal/inconsistent oral intake
    3. Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7)
    4. Total oral intake of a single consistency
    5. Total oral intake of multiple consistencies requiring special preparation
    6. Total oral intake with no special preparation, but must avoid specific foods or liquid items
    7. Total oral intake with no restrictions

  4. Participant perception of swallowing related symptoms as confirmed by The Eating Assessment Tool 10 (EAT-10) [ Time Frame: Baseline ]
    EAT-10 is a 10-item validated self-administered dysphagia severity symptom survey. Score is 0 - 40 with 0 being the best possible score and 40 the worst possible score.

  5. Participant perception of communication abilities as confirmed by Communication Effectiveness Survey [ Time Frame: Baseline ]
    A measure of self-rated communication abilities across a variety of settings as perceived by the patients and/or their caregivers will be measured using the 8-point Communication Effectiveness Survey (CES)

  6. Bulbar function confirmed by the Center for Neurologic Studies Bulbar Function Scale (CNS-BFS) [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710162


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32605
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Emily Plowman, Ph.D. University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02710162     History of Changes
Other Study ID Numbers: IRB201600163
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs