Trial Outcomes & Findings for Physiological Flow of Liquids Used in Dysphagia Management (Neuro) (NCT NCT03192358)

NCT ID: NCT03192358

Last Updated: 2022-09-15

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

40 participants

Primary outcome timeframe

Single timeframe (baseline only)

Results posted on

2022-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	Amyotrophic Lateral Sclerosis (ALS) Adults with a neurologist-confirmed diagnosis of ALS who completed a videofluoroscopy involving swallows of different liquid consistencies.	Parkinson Disease Adults with a neurologist-confirmed diagnosis of Parkinson Disease who completed a videofluoroscopy involving swallowing of different consistencies of liquid.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Physiological Flow of Liquids Used in Dysphagia Management (Neuro)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Amyotrophic Lateral Sclerosis n=20 Participants 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. Videofluoroscopic Swallowing Examination: 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 Measurement: 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).	Parkinson's Disease n=20 Participants 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. Videofluoroscopic Swallowing Examination: 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 Measurement: 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).	Total n=40 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	70 years n=7 Participants	67 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Single timeframe (baseline only)

Population: Two cohorts of participants were enrolled in this observational study: 1) A cohort of 20 adults with Amyotrophic Lateral Sclerosis (ALS); and 2) A cohort of 20 adults with Parkinson disease. Due to data quality issues, partial data were missing for some consistencies.

Outcome measures

Outcome measures
Measure	Amyotrophic Lateral Sclerosis: Thin Liquids n=20 Participants Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Slightly Thick Liquids n=19 Participants Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Mildly Thick Liquids n=18 Participants Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Moderately Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Extremely Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Thin Liquid n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Parkinson Disease: Slightly Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Mildly Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Moderately Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Extremely Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).
Number of Participants With Residue of Concern (Observational)	6 Participants	6 Participants	3 Participants	6 Participants	4 Participants	2 Participants	3 Participants	3 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: Single timeframe (baseline only)

Population: Two cohorts of participants were enrolled: 1) A cohort of 20 adults with Amyotrophic Lateral Sclerosis (ALS); and 2) A cohort of 20 adults with Parkinson disease. Due to data quality issues, anterior isometric pressure data were missing for 3 of the participants with ALS.

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.

Outcome measures

Outcome measures
Measure	Amyotrophic Lateral Sclerosis: Thin Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Slightly Thick Liquids n=20 Participants Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Mildly Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Moderately Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Extremely Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Thin Liquid Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Parkinson Disease: Slightly Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Mildly Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Moderately Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Extremely Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).
Maximum Anterior Isometric Tongue Pressure	34 kilopascals Standard Deviation 19	55 kilopascals Standard Deviation 17	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Single timeframe (baseline only)

Population: Two cohorts of participants were enrolled: 1) A cohort of 20 adults with Amyotrophic Lateral Sclerosis (ALS); and 2) A cohort of 20 adults with Parkinson disease. Due to data quality issues, saliva swallow tongue pressure data were missing for 3 of the participants with ALS.

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.

Outcome measures

Outcome measures
Measure	Amyotrophic Lateral Sclerosis: Thin Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Slightly Thick Liquids n=20 Participants Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Mildly Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Moderately Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Extremely Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Thin Liquid Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Parkinson Disease: Slightly Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Mildly Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Moderately Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Extremely Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).
Regular Effort Saliva Swallow Tongue Pressure	19 kilopascals Standard Deviation 12	17 kilopascals Standard Deviation 8	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Single timepoint only)

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.

Outcome measures

Outcome measures
Measure	Amyotrophic Lateral Sclerosis: Thin Liquids n=20 Participants Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Slightly Thick Liquids n=19 Participants Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Mildly Thick Liquids n=18 Participants Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Moderately Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Extremely Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Thin Liquid n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Parkinson Disease: Slightly Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Mildly Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Moderately Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Extremely Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).
Number of Participants With Unsafe Swallows (Observational)	10 Participants	9 Participants	7 Participants	6 Participants	3 Participants	2 Participants	1 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Single timeframe (baseline only)

Population: Two cohorts of participants were enrolled: 1) A cohort of 20 adults with Amyotrophic Lateral Sclerosis (ALS); and 2) A cohort of 20 adults with Parkinson disease. Due to data quality issues, posterior isometric pressure data were missing for 3 of the participants with ALS.

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.

Outcome measures

Outcome measures
Measure	Amyotrophic Lateral Sclerosis: Thin Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Slightly Thick Liquids n=20 Participants Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Mildly Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Moderately Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Extremely Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Thin Liquid Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Parkinson Disease: Slightly Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Mildly Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Moderately Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Extremely Thick Liquids Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).
Maximum Posterior Isometric Tongue Pressure (Observational).	29 kilopascals Standard Deviation 20	51 kilopascals Standard Deviation 19	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Single timeframe (baseline only)

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.

Outcome measures

Outcome measures
Measure	Amyotrophic Lateral Sclerosis: Thin Liquids n=20 Participants Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Slightly Thick Liquids n=19 Participants Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Mildly Thick Liquids n=18 Participants Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Moderately Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Extremely Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Thin Liquid n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Parkinson Disease: Slightly Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Mildly Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Moderately Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Extremely Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).
Number of Participants With Multiple Swallows Per Bolus (Observational)	6 Participants	8 Participants	9 Participants	5 Participants	8 Participants	6 Participants	3 Participants	2 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Single timeframe (baseline only)

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.

Outcome measures

Outcome measures
Measure	Amyotrophic Lateral Sclerosis: Thin Liquids n=18 Participants Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Slightly Thick Liquids n=19 Participants Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Mildly Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Moderately Thick Liquids n=15 Participants Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Amyotrophic Lateral Sclerosis: Extremely Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Thin Liquid n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of thin liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water) and swallow when ready (without a cue).	Parkinson Disease: Slightly Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of slightly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Mildly Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of mildly thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Moderately Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of moderately thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).	Parkinson Disease: Extremely Thick Liquids n=17 Participants Participants were asked to swallow a series of 3 comfortably sized sips of extremely thick liquid barium (Bracco E-Z-Paque powder prepared in 20% w/v concentration with water and Nestle Resource Thicken Up Clear Xanthan Gum thickener) and swallow when ready (without a cue).
Number of Participants Displaying Prolonged Pharyngeal Bolus Transit (Observational)	5 Participants	10 Participants	7 Participants	7 Participants	8 Participants	5 Participants	4 Participants	5 Participants	5 Participants	6 Participants

Adverse Events

Amyotrophic Lateral Sclerosis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Parkinson's Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director, Swallowing Rehabilitation Research Laboratory

University Health Network

Phone: 416 597 3422

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place