Amyotrophic Lateral SclerosisNCT03192358
Physiological Flow of Liquids Used in Dysphagia Management (Neuro)
An observational study of Amyotrophic Lateral Sclerosis and Parkinson Disease, run by University Health Network, Toronto at 1 site in United States.
Trial summary
For individuals with neurodegenerative conditions, such as Amyotrophic Lateral Sclerosis and Parkinson disease, swallowing impairment (i.e., dysphagia) is a common and serious symptom. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Parkinson Disease, Dysphagia
- What is being tested?
- Videofluoroscopic Swallowing Examination and Tongue Strength Measurement
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 31 Dec 2020
- Phase
- Observational
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: Participants with ALS will be recruited from the multidisciplinary ALS clinics at the University of Florida during regularly scheduled care visits. Participants with Parkinson's disease will be recruited from the University of Florida Center for Movement Disorders.
Who may be able to join
- Adults (18+) with a confirmed diagnosis of Amyotrophic Lateral Sclerosis (ALS) or Parkinson's disease (PD)
Who cannot join
- People with a prior medical history of stroke
- People with a prior medical history of acquired brain injury
- People with a prior medical history of spinal or spinal cord injury
- People with a prior medical history of cancer or surgery in the head and neck region
- People who have had radiation to the head and neck for cancer
- People who have a prior history of swallowing problems (e.g., from childhood, medical complication)
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- People with significant breathing difficulties (e.g., rely on mechanical ventilation)
- People who rely solely on tube-feeding for all meals and nutrition
- People who have Type I (insulin-dependent) Diabetes
- Women who are pregnant
- People who have allergies to barium, potato starch, corn starch, xanthan gum, milk products, latex or dental glue
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological Flow of Liquids Used in Dysphagia Management
For individuals with neurodegenerative conditions, such as Amyotrophic Lateral Sclerosis and Parkinson disease, swallowing impairment (i.e., dysphagia) is a common and serious symptom. Dysphagia places the affected individual at risk for secondary health consequences, including malnutrition and aspiration pneumonia, and negatively affects quality of life.
Thickened liquids are commonly recommended for individuals with dysphagia, as they flow more slowly and reduce the risk of entry into the airway. However, there is limited understanding about how changes in liquid thickness modulate swallowing physiology in individuals with neurodegenerative conditions, and previous reports have shown that increased liquid thickness may contribute to the accumulation of residue in the throat.
The purpose of this study is to explore swallowing physiology and function in individuals with neurodegenerative conditions, across five levels of liquid thickness (thin, slightly-thick, mildly-thick, moderately-thick, and extremely-thick), and to identify boundaries of "optimal liquid thickness", which maintain airway safety, without contributing to the accumulation of significant residue. Results from this study will help guide the clinical recommendations for thickened liquids in dysphagia management.
Read the detailed description
This observational research study will measure swallowing function in individuals with Amyotrophic Lateral Sclerosis or Parkinson's disease. The aims of this study are to (1) identify parameters of swallowing physiology that are associated with impaired swallowing safety and efficiency, and (2) explore how liquid thickness influences swallowing function.
Participation in this research study involves a single appointment at the University of Florida Swallowing Systems Core laboratory located at Shands Hospital, Gainesville. The appointment will last approximately 1 hour, and will involve tasks to measure tongue-strength, and a dynamic swallowing x-ray (known as videofluoroscopy) to evaluate swallowing function. A selection of demographic information (e.g., age, onset of symptoms) will also be recorded.
To measure tongue strength, participants will be given a disposable air-filled bulb and asked to perform a series of tongue presses, and swallow their saliva. Next, during the videofluoroscopy, participants will take sips of various liquids ranging in thickness from thin (like water), to extremely-thick (similar to the consistency of pudding or yogurt). The liquids will be mixed with a safe substance called barium, to make them visible on x-ray images. After the videofluoroscopy has been completed, each participant will have their tongue strength measured again, which will conclude their participation in the study.
Swallowing physiology will be measured from the videofluoroscopy images, post-hoc, by an experienced team of blinded raters.
- Conditions
- Amyotrophic Lateral Sclerosis, Parkinson Disease, Dysphagia
- Being tested
- Videofluoroscopic Swallowing Examination, Tongue Strength Measurement
- Keywords
- Thickened Liquids, Dysphagia Management, Videofluoroscopy, Swallowing Physiology
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Parkinson Disease, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videofluoroscopic Swallowing ExaminationDiagnostic test
During the videofluoroscopy, subjects will take up to 21 sips of liquid, ranging in thickness from thin (like water), to extremely-thick (like pudding or custard). The liquids will be mixed with E-Z-Paque barium sulfate, to allow it to be visible on the x-ray.
Tongue Strength MeasurementOther
We will measure tongue strength using a tongue pressure measurement system called the Iowa Oral Performance Instrument (IOPI). A small disposable bulb filled with air will be placed in the mouth, just behind the front teeth. Participants will be asked to press their tongue upwards against the bulb as hard as they can, three (3) times at the front of the tongue and three (3) times at the back of the tongue (i.e., total of six (6) maximum isometric tongue presses). Participants will also be asked to swallow their saliva with the bulb placed in their mouth, three (3) times.
Tongue pressure measurement will be completed twice in the data collection session - once at the beginning, and once at the end (following the videofluoroscopy).
| Study group | Role | What they receive |
|---|---|---|
| Amyotrophic Lateral Sclerosis | We will be recruiting individuals with confirmed or probably ALS, who experience speech or swallowing problems, to attend one data collection session. All participants will undergo the same protocol, including a Videofluoroscopic Swallowing Examination, and Tongue Strength Measurement. Receives: Diagnostic Test: Videofluoroscopic Swallowing Examination; Other: Tongue Strength Measurement | |
| Parkinson's Disease | We will be recruiting individuals with a diagnosis of Parkinson's disease, who experience speech or swallowing problems, to attend one data collection session. All participants will undergo the same protocol, including a Videofluoroscopic Swallowing Examination, and Tongue Strength Measurement. Receives: Diagnostic Test: Videofluoroscopic Swallowing Examination; Other: Tongue Strength Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Residue of Concern (Observational)
Residue is material remaining behind in the pharynx after the swallow. We measured residue by tracing the area of barium visible on a lateral view x-ray (in pixels, using ImageJ software) and dividing that area by the squared length C2-C4 cervical spine. This cervical spine scalar provides a common anatomical reference that is a proxy for pharyngeal size, and enables the comparison of residue severity across different people with different neck length and pharynx size. Smaller values are considered better. The 75th percentile healthy reference values for this measure are 1.7% on thin liquids, 1.9% on slightly thick liquids, 2.2% on mildly thick liquids, 1.6% on moderately thick liquids and 1.5% on extremely thick liquids. Values above these thresholds are considered atypical and of clinical concern. We report the number of participants who display atypical total pharyngeal residue measures per consistency.
Measured: Single timeframe (baseline only)
Maximum Anterior Isometric Tongue Pressure
Tongue strength was measured using a tongue pressure measurement system called the Iowa Oral Performance Instrument (IOPI). A small disposable bulb filled with air was placed in the mouth, just behind the front teeth. Participants were asked to press the front of their tongue upwards against the bulb as hard as possible. This task was repeated 3 times. The maximum value obtained across 3 repetitions was recorded as "maximum anterior isometric pressure". Higher values represent greater tongue strength. We report group mean values and standard deviations for this measure.
Measured: Single timeframe (baseline only)
Regular Effort Saliva Swallow Tongue Pressure
Tongue strength was measured using a tongue pressure measurement system called the Iowa Oral Performance Instrument (IOPI). A small disposable bulb filled with air was placed in the mouth, just behind the front teeth. Participants were asked to swallow their saliva with the bulb in this position. This task was repeated 3 times. The mean value obtained across 3 repetitions was recorded as "regular effort saliva swallow tongue pressure". Higher values represent greater tongue strength. We report group mean values and standard deviations for this measure.
Measured: Single timeframe (baseline only)
Number of Participants With Unsafe Swallows (Observational)
Swallowing safety was measured using the 8-point Penetration-Aspiration Scale, an 8-point categorical scale which captures the depth to which any material enters the airway and whether or not the material is ejected. Levels 1 and 2 on the scale are considered safe, while levels > 2 are considered unsafe. Actual scale scores (1-8) were recorded and then converted to binary categorical scores (< 3 vs >/= 3). We report the frequency (count) of participants showing scores > 2 by bolus consistency.
Measured: Baseline (Single timepoint only)
Secondary outcomes (3)
Maximum Posterior Isometric Tongue Pressure (Observational).
Tongue strength was measured using a tongue pressure measurement system called the Iowa Oral Performance Instrument (IOPI). A small disposable bulb filled with air was placed in the mouth, with the front margin of the sensor aligned with the first molar tooth. Participants were asked to press the back of their tongue upwards against the bulb as hard as possible. This task was repeated 3 times. The maximum value obtained across 3 repetitions was recorded as "maximum posterior isometric pressure". Higher values represent greater tongue strength. We report group mean values and standard deviations for this measure. There was no statistical analysis comparing group values for this parameter.
Measured: Single timeframe (baseline only)
Number of Participants With Multiple Swallows Per Bolus (Observational)
The number of swallows needed to clear a single bolus will be counted. A single swallow is considered efficient, while 2+ swallows for one bolus is considered atypical. We will report the number of participants with > 1 swallow per bolus.
Measured: Single timeframe (baseline only)
Number of Participants Displaying Prolonged Pharyngeal Bolus Transit (Observational)
The time interval from the first frame showing the bolus entering the pharynx (passing the shadow of the ramus of the mandible) until the first frame showing the bolus entering the upper esophageal sphincter was calculated (in milliseconds) for each bolus. The 75th percentile healthy reference values for this measure are 533 ms on thin liquids, 567 ms on slightly thick liquids, 701 ms on mildly thick liquids, 867 ms on moderately thick liquids and 1001 ms on extremely thick liquids. Pharyngeal transit durations above these values are considered prolonged and atypical. We will report the number of participants who present with atypical pharyngeal transit duration above these 75th percentile reference value thresholds per consistency.
Measured: Single timeframe (baseline only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start1 Nov 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Catriona M Steele, PhD, Principal investigator, University Health Network - Toronto Rehabilitation InstituteEmily K Plowman, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192358
- Sponsor's protocol ID
- 17-5421
- Other IDs
- 5R01DC011020-05, CAPCR 17-5421 (NIH_Neuro), IRB201701608
- Status last verified
- Mar 2021
- First submitted
- 12 Jun 2017
- Last updated
- 15 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pearson WG Jr, Molfenter SM, Smith ZM, Steele CM. Image-based measurement of post-swallow residue: the normalized residue ratio scale. Dysphagia. 2013 Jun;28(2):167-77. doi: 10.1007/s00455-012-9426-9. Epub 2012 Oct 23.
PubMed 23089830Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.
PubMed 8721066