Amyotrophic Lateral SclerosisNCT02962050
Delineating Swallowing Impairment and Decline in ALS
An observational study of Amyotrophic Lateral Sclerosis, run by University of Florida at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Videofluoroscopic Swallowing Study (VFSS), Voluntary Peak Cough Flow Testing and Iowa Oral Performance Instrument
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- How many people
- 109 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 May 2017to 16 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with Amyotrophic Lateral Sclerosis
Who may be able to join
- diagnosis of probable or definite ALS
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida
Gainesville, Florida, 32605
University of South Florida
Tampa, Florida, 33620
About this study
Official title: Delineating Physiologic Mechanisms of Swallowing Impairment and Decline in ALS
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.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Videofluoroscopic Swallowing Study (VFSS), Voluntary Peak Cough Flow Testing, Iowa Oral Performance Instrument, Capsaicin Challenge, Pulmonary Function Testing
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videofluoroscopic Swallowing Study (VFSS)Procedure or surgery
Also called VFSS, X-Ray of Swallowing, Modified Barium Swallow Study
Videofluoroscopic swallowing study will be performed to measure oropharyngeal swallowing
Voluntary Peak Cough Flow TestingDevice
Voluntary peak cough flow testing will be performed to determine the peak expiratory flow (PEF) and volume of air expelled (FEV1) during voluntary coughing.
Iowa Oral Performance InstrumentDevice
Also called IOPI
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.
Capsaicin ChallengeDrug
Also called Reflexive Cough Testing
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 TestingDevice
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.
Eating Assessment Tool 10Other
Also called EAT 10
The Eating Assessment Tool-10 will be used for participant reporting of swallowing system severity.
The Center for Neurologic Study Bulbar Function ScaleOther
Also called CNS-BFS
The Center for Neurologic Studies Bulbar Function Scale (CNS-BFS) will be used to report bulbar function in study participants.
| Study group | Role | What they receive |
|---|---|---|
| ALS | Participants enrolled will complete the following tests: Videofluoroscopic Swallowing Study, Voluntary Peak Cough Flow Testing, lingual strength and endurance trials using the Iowa Oral Performance Instrument, reflexive cough testing, Pulmonary Function Testing; 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). Receives: Procedure: Videofluoroscopic Swallowing Study (VFSS); Device: Voluntary Peak Cough Flow Testing; Device: Iowa Oral Performance Instrument; Drug: Capsaicin Challenge; Device: Pulmonary Function Testing; Other: Eating Assessment Tool 10; Other: The Center for Neurologic Study Bulbar Function Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Swallowing Function
The 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.
Measured: Baseline, every 3 months through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study start31 May 2017
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Plowman, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962050
- Sponsor's protocol ID
- IRB201602098-N
- Other IDs
- R01NS100859
- Status last verified
- Feb 2023
- First submitted
- 4 Nov 2016
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delineating Physiologic Mechanisms of Swallowing Impairment and Decline in ALS
- ClinicalTrials.gov ID
- NCT02962050
- Acronym / sponsor ID
- IRB201602098-N
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 31 May 2017 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALS | – | Procedure: Videofluoroscopic Swallowing Study (VFSS), Device: Voluntary Peak Cough Flow Testing, Device: Iowa Oral Performance Instrument, Drug: Capsaicin Challenge, Device: Pulmonary Function Testing, Other: Eating Assessment Tool 10, Other: The Center for Neurologic Study Bulbar Function ScaleParticipants enrolled will complete the following tests: Videofluoroscopic Swallowing Study, Voluntary Peak Cough Flow Testing, lingual strength and endurance trials using the Iowa Oral Performance Instrument, reflexive cough testing, Pulmonary Function Testing; 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). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with Amyotrophic Lateral Sclerosis
Key inclusion criteria (1 listed)
- diagnosis of probable or definite ALS
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Videofluoroscopic Swallowing Study (VFSS)Also: VFSS, X-Ray of Swallowing, Modified Barium Swallow StudyVideofluoroscopic swallowing study will be performed to measure oropharyngeal swallowing | Procedure or surgery | ALS |
| Voluntary Peak Cough Flow TestingVoluntary peak cough flow testing will be performed to determine the peak expiratory flow (PEF) and volume of air expelled (FEV1) during voluntary coughing. | Device | ALS |
| Iowa Oral Performance InstrumentAlso: IOPIThe 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. | Device | ALS |
| Capsaicin ChallengeAlso: Reflexive Cough TestingA 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. | Drug | ALS |
| Pulmonary Function TestingPulmonary 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. | Device | ALS |
| Eating Assessment Tool 10Also: EAT 10The Eating Assessment Tool-10 will be used for participant reporting of swallowing system severity. | Other | ALS |
| The Center for Neurologic Study Bulbar Function ScaleAlso: CNS-BFSThe Center for Neurologic Studies Bulbar Function Scale (CNS-BFS) will be used to report bulbar function in study participants. | Other | ALS |
Primary outcome
Global Swallowing Function
Time frame: Baseline, every 3 months through study completion, an average of 2 years.
The 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Plowman, PhD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Swallowing Function (time frame: Baseline, every 3 months through study completion, an average of 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.