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Trial record 4 of 33 for:    Cough | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Delineating Swallowing Impairment and Decline in ALS

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ClinicalTrials.gov Identifier: NCT02962050
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : July 6, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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.

Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Procedure: Videofluoroscopic Swallowing Study (VFSS) Procedure: High Resolution Manometry Other: DIGEST Other: Penetration Aspiration Scale Other: Normalized Residue Ratio Scale Device: Voluntary Peak Cough Flow Testing Device: Iowa Oral Performance Instrument Device: Lingual Electrical Impedance Myography Drug: Capsaicin Challenge Device: Pulmonary Function Testing Other: Eating Assessment Tool 10 Other: The Center for Neurologic Study Bulbar Function Scale

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 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 Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Delineating Physiologic Mechanisms of Swallowing Impairment and Decline in ALS
Actual Study Start Date : May 31, 2017
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2024


Group/Cohort Intervention/treatment
ALS Bulbar Onset
Participants enrolled will have the following tests: Videofluoroscopic Swallowing Study (with swallowing analyses performed using the validated scales of DIGEST, Penetration Aspiration Scale, and Normalized Residue Ratio Scale) ; High Resolution Manometry, Voluntary Peak Cough Flow Testing, lingual strength and endurance trials using the Iowa Oral Performance Instrument, Lingual Electrical Impedance Myography of the tongue, reflexive cough testing using a capsaicin challenge and Pulmonary Function Testing. In addition, the patient will complete the following surveys: Eating Assessment Tool-10 (EAT-10), Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), and the The Center for Neurologic Study Bulbar Function Scale (CNS-BFS).
Procedure: Videofluoroscopic Swallowing Study (VFSS)
Videofluoroscopic swallowing study will be performed to measure oropharyngeal swallowing
Other Names:
  • VFSS
  • X-Ray of Swallowing
  • Modified Barium Swallow Study

Procedure: High Resolution Manometry
High resolution manometry will be performed to measure pressures across the various anatomical zones of swallowing.
Other Name: HRM

Other: DIGEST
DIGEST will be used to analyze the safety and efficiency of swallowing bolus trials.

Other: Penetration Aspiration Scale
The Penetration Aspiration Scale will be used to analyze the safety of the swallowing bolus trials.
Other Name: PAS

Other: Normalized Residue Ratio Scale
The Normalized Residue Ratio Scale will be used to analyze the efficiency of the swallowing bolus trials.
Other Name: NRRS

Device: Voluntary Peak Cough Flow Testing
Voluntary peak cough flow testing will be performed to determine the peak expiratory flow (PEF) and volume of air expelled (FEV1) during voluntary coughing.

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: Lingual 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 Challenge
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: Reflexive Cough Testing

Device: Pulmonary Function Testing
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.

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: The Center for Neurologic Study 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

ALS Limb Onset
Participants enrolled will have the following tests: Videofluoroscopic Swallowing Study (with swallowing analyses performed using the validated scales of DIGEST, Penetration Aspiration Scale, and Normalized Residue Ratio Scale) ; High Resolution Manometry, Voluntary Peak Cough Flow Testing, lingual strength and endurance trials using the Iowa Oral Performance Instrument, Lingual Electrical Impedance Myography of the tongue, reflexive cough testing using a capsaicin challenge and Pulmonary Function Testing. In addition, the patient will complete the following surveys: Eating Assessment Tool-10 (EAT-10), Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), and the The Center for Neurologic Study Bulbar Function Scale (CNS-BFS).
Procedure: Videofluoroscopic Swallowing Study (VFSS)
Videofluoroscopic swallowing study will be performed to measure oropharyngeal swallowing
Other Names:
  • VFSS
  • X-Ray of Swallowing
  • Modified Barium Swallow Study

Procedure: High Resolution Manometry
High resolution manometry will be performed to measure pressures across the various anatomical zones of swallowing.
Other Name: HRM

Other: DIGEST
DIGEST will be used to analyze the safety and efficiency of swallowing bolus trials.

Other: Penetration Aspiration Scale
The Penetration Aspiration Scale will be used to analyze the safety of the swallowing bolus trials.
Other Name: PAS

Other: Normalized Residue Ratio Scale
The Normalized Residue Ratio Scale will be used to analyze the efficiency of the swallowing bolus trials.
Other Name: NRRS

Device: Voluntary Peak Cough Flow Testing
Voluntary peak cough flow testing will be performed to determine the peak expiratory flow (PEF) and volume of air expelled (FEV1) during voluntary coughing.

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: Lingual 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 Challenge
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: Reflexive Cough Testing

Device: Pulmonary Function Testing
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.

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: The Center for Neurologic Study 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. Change in Maximum Swallowing Pressure with High Resolution Manometry (HRM) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    HRM will measures maximum pressure (mmHg) across 4 anatomical zones.

  2. Change in Rate of Pressure with High Resolution Manometry (HRM) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    HRM will measure rate of pressure (mmHg) increase across 4 anatomical swallowing zones.

  3. Change in Mean Pressure with High Resolution Manometry (HRM) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    HRM will measure mean pressure (mmHg) across 4 anatomical swallowing zones.

  4. Swallowing Safety (with DIGEST) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    The validated DIGEST scale will be used by trained, blinded raters to assign ratings of safety to bolus trials. Both efficiency and safety will be assigned a score from 0-4 (more safe/efficient - less safe/efficient) and based on these ratings, will be given a total score ranging from 0-4 that captures their DIGEST rating.

  5. Swallowing Efficiency (with DIGEST) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    The validated DIGEST scale will be used by trained, blinded raters to assign ratings of efficiency to bolus trials. Both efficiency and safety will be assigned a score from 0-4 (more safe/efficient - less safe/efficient) and based on these ratings, will be given a total score ranging from 0-4 that captures their DIGEST rating.

  6. Swallowing Efficiency (with NRRS) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    The validated Normalized Residue Ratio Scale (NRRS) is a validated measurement tool that is used to quantify the amount of residue remaining in the valleculae and pyriform sinus after bolus trials. Inefficient swallows are those swallows with an NRRS valleculae (NRRSv) rating of 0.07 or greater and an NRRS pyriform sinus (NRRSp) rating of 0.2 or greater. Efficient swallows will be those calculated to have an NRRSv value of <.07 and/or NRRSp value of <.02.

  7. Swallowing Safety (with PAS) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    The Penetration Aspiration scale is an 8-point, interval scale that will be used by trained, blinded to assign ratings of safety to swallowing bolus trials. Unsafe PAS scores will be those greater than 3 and safe scores are those assigned a rating of 1 or 2.

  8. Change in Forced Vital Capacity with Pulmonary Function Testing (with hand-held digital manometer) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    Pulmonary function testing will be used to determine forced vital capacity (FVC).

  9. Voluntary Peak Cough Flow Testing (with Electronic Peak Cough Flow Meter Device) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    Voluntary peak cough flow testing will be used to capture the volume of air expelled in the 1st second of cough as measured in PEF and FEV1.

  10. Change in Lingual Strength with Lingual Function Testing (with IOPI) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    Lingual function testing will be used to measure maximum anterior lingual pressure (kPA).

  11. Change in Lingual Physiologic Reserve with Lingual Function Testing (IOPI) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    Lingual function testing will be used to measure lingual physiologic functional reserve (kPA)

  12. Change in Lingual Swallowing Pressure with Lingual Function Testing (IOPI) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    Lingual strength testing will be used to measure lingual pressure during swallowing (kPA).

  13. Change in Lingual Resistance with Lingual Electrical Impedance Myography (with SFB7 ImpediMed device) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    Lingual EIM will be used to assess the health of the lingual musculature by assessing this muscle using an electrode that will apply a current and a frequency spectrum ranging from 500 Hz to 2 megahertz (MHz) will be analyzed to determine resistance (Ohms) of the tongue.

  14. Change in Lingual Reactance with Lingual Electrical Impedance Myography (EIM) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    Lingual EIM will be used to assess the health of the lingual musculature by assessing this muscle using an electrode that will apply a current and a frequency spectrum ranging from 500 Hz to 2 MHz will be analyzed to determine reactance (Ohms) of the tongue.

  15. Change in Phase Angle with Lingual Electrical Impedance Myography (EIM) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    Lingual EIM will be used to assess the health of the lingual musculature by assessing this muscle using an electrode that will apply a current and a frequency spectrum ranging from 500 Hz to 2 MHz will be analyzed to determine phase angle (degrees) of the tongue.

  16. Change in Reflexive Cough Testing (with Urge-to-Cough) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    Reflexive cough testing will use a capsaicin challenge that will assess individual's cough motor and cough sensory thresholds. A modified Borg scale ranging from 0 (no cough) to 10 (maximal urge to cough) will be used to quantify these thresholds. A cough sensory threshold will be defined as a concentration of capsaicin eliciting a perceived urge to cough of 1 (very slight) >2/3 trials. A cough motor threshold will be the lowest concentration of capsaicin eliciting >2 cough responses in 2/3 trials.

  17. Change in Maximum Expiratory Pressure with Pulmonary Function Testing (with hand-held digital manometer) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    Pulmonary Function Testing will be used to determine maximum expiratory pressure (MEP).

  18. Change in Maximum Inspiratory Pressure with Pulmonary Function Testing (with hand-held digital manometer) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    Pulmonary function testing will be used to determine maximum inspiratory pressure (MIP).


Secondary Outcome Measures :
  1. Eating Assessment Tool 10 [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    The Eating Assessment Tool 10 will be used to allow patients to rate their perception of 10 swallowing symptoms on a scale from 0 (no problem) to 4 (severe problem). An EAT-10 score of 3 or higher might be indicative of swallowing safety and efficiency problems.

  2. Center for Neurologic Study Bulbar Function Scale [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    The CNS-BFS is a scale that allows patients to self report perceptions regarding three domains (swallowing, speech and salivation). Each domain contains perceptual ratings ranging from 1-7 with 7 considered the worst.

  3. The Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) [ Time Frame: Baseline, every 3 months through study completion, an average of 2 years. ]
    The ALSFRS-R is a 12-item questionnaire that provides information regarding bulbar, limb, and respiratory function in persons as disease progresses. Each question is rated on a scaled ranging from 4 (better) to 0 (worst). Scores are calculated and expressed out of 48 total points.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with Amyotrophic Lateral Sclerosis
Criteria

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

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): NCT02962050


Contacts
Contact: Raele Robison, MS 6105044605 raerobison1@ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32605
Contact: Raele Robison, MS    610-504-4605    raerobison1@ufl.edu   
University of Florida College of Medicine Recruiting
Jacksonville, Florida, United States, 32209
Contact: Michael Pulley, MD         
University of South Florida Recruiting
Tampa, Florida, United States, 33620
Contact: Emily Plowman, PhD         
Sponsors and Collaborators
University of Florida
National Institutes of Health (NIH)
Investigators
Principal Investigator: Emily Plowman, PhD University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02962050     History of Changes
Other Study ID Numbers: IRB201602098-N
NS100859 ( Other Grant/Funding Number: NINDS )
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
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