Brain Injury, Head and Neck Cancer, Stroke
Conditions
Brief summary
The purpose of this study is to develop appropriate training methods and gather participant feedback on their use of the Passy Muir Swallowing Self-Training Device (PMSST). The PMSST is a small device that provides external vibratory stimulation to the larynx during swallowing and swallowing training. A secondary purpose of the study is to determine how 3 months of use of the PMSST affects swallowing physiology, brain activation, oral intake and quality of life. This was an uncontrolled pilot study aimed at gaining patient feedback on use of the vibratory device.
Detailed description
The investigators are currently developing the Passy Muir Swallowing Self-Trainer to continue treatment of dysphagia after the patient is discharged to home. The self-training device is worn around the neck with motors placed externally on the skin over the thyroid cartilage to provide vibratory stimulation to the larynx. The vibrations activate the sensory receptors inside the larynx which excite central nervous system (CNS) control for swallowing and can help the patient to initiate swallowing. Patients can use the self-training device at home to promote swallowing rehabilitation during daily swallowing practice. The device can also be programmed to vibrate at regular intervals throughout the day to promote saliva swallows. Using this method, the patient can continue their swallowing therapy independently and in a manner that is cost effective. A previous Phase I trial compared the clinical outcomes of 8 patients with chronic dysphagia using either an intramuscular electrical stimulation implant device or an external vibratory stimulator to practice swallowing daily at home. Functional outcomes of oral intake improved with both devices. As the external vibratory stimulation has the advantage of being external and completely noninvasive, it has been selected for further development as a self-training device. A second pilot study examined the effect of different frequencies of vibration on the swallowing frequency of healthy participants and found swallowing rate significantly increased from baseline when using a vibration of either 70 Hz or 150 Hz (Mulheren and Ludlow, 2017). Data has also been collected on the effect of different vibration characteristics on swallowing in participants who have swallowing problems after stroke (Kamarunas et al., in press). Purpose: The purpose of this study is to allow patients with chronic dysphagia to use the Self-Trainer for daily swallowing practice in their home and collect feedback on device use and satisfaction and use. Objective information on the effectiveness of self-training for swallowing rehabilitation will also be gathered. Objectives: 1. To develop and evaluate training for participants and caregivers to use the self-trainer. 2. To gather participant feedback on the use of the device after 3 months of daily practice. 3. To determine how 3 months of daily practice with the Passy Muir Swallowing Self-Trainer affects swallowing physiology, brain activation, oral intake, and quality of life in participants with chronic dysphagia.
Interventions
DEVICEDysphagia retraining with device
Patients used the device for 60 trials of retraining swallowing at home each day and also had the device turned on throughout the day in automatic mode to intermittently trigger every few minutes to trigger a swallow for saliva control
Sponsors
Passy Muir Inc.
James Madison University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
13 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 13 years or older * Stable medical condition * Diagnosed with oropharyngeal dysphagia confirmed by Modified Barium Swallow (MBS) baseline measure of the follow two scales: 1. Penetration-Aspiration Scale score of 2 or greater verified by modified barium swallow (Rosenbek et al., 1996) and/or 2. Functional Oral Intake Scale score of 5 or lower (Crary et al., 2005) * Folstein Mini-Mental State Examination (MMSE) score of 23 or greater indicating cognitive ability to follow directions and communicate preferences * Willingness to travel to Sentara Rockingham Memorial Hospital 2 or more times to undergo initial evaluation, device use training and checkup at 3 months.
Exclusion criteria
* Pregnancy * Cardiac problems * history of cardiac rhythm condition (including heart murmur or cardiac arrhythmia) * cardiac pacemaker in place * Highly-pigmented (dark) skin color is an exclusion criterion because near-infrared spectroscopy requires the measurement of the degree of absorption of different wavelengths of light after being reflected back through the scalp. Highly pigmented skin interferes with wavelength transmission, making the measurement of changes in absorption inaccurate. * Lack of a primary care physician who can be contacted if there are findings on the Magnetic Resonance Imaging (MRI) scan. * Presence of metal in the body (prostheses, electrodes, shrapnel, aneurism clips, other medical hardware) * Presence of certain tattoos with ferromagnetic metal or permanent makeup, due to the exposure to high magnetic force through MRI procedures. * Subjects who were metal workers as a previous occupation will also be excluded due to the possibility of unknown/undetected metal in their body. * Volunteers with broken skin in the area that the functional Near Infra-Red Spectroscopy (fNIRS) probes will be placed on the scalp * Claustrophobia * Previous surgery that used surgical staples * Artificial joints
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dysphagia Outcome and Severity Scale (DOSS) Rating | From before onset of device use to return 3 months later | An ordinal scale of 7 levels of severity of swallowing disorder with 1 being the lowest level and 7 being the highest level. Level 1 is Severe dysphagia Nothing per oral and unable to tolerate any per oral liquid/substance safely. Level 2 is Moderately severe dysphagia, requires maximum assistance or use of strategies with partial per oral only, tolerates at least one consistency safely with total use of strategies. Level 3 is Moderate Dysphagia, requires total assist, supervision, or strategies with two or more consistencies restricted. Level 4 is Mild-moderate Dysphagia, Requires intermittent supervision/cueing, one or two consistencies restricted level 5 is Mild dysphagia: requires distant supervision may need one diet consistency restricted Level 6 Within functional limits, modified independence Level 7 Normal in all situations |
| Dysphagia Handicap Index (DHI) | From before onset of device use to return 3 months later | Total handicap Score from 0 (no Handicap) to 100 (Severe Handicap) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laryngeal Elevation Relative to Hyoid Elevation for Vestibule Closure | From before onset of device use to return 3 months later | Calibrated kinematic measures from videofluoroscopic imaging during a modified barium swallow study. Computed the change in peak elevation in millimeters during swallowing from the rest position before swallowing for two structures: the larynx and the hyoid bone. The peak elevation of the two structures were compared by subtracting the hyoid peak elevation from the laryngeal peak elevation. If the measure was positive the larynx was elevated to a greater degree than the hyoid bone resulting in vestibule closure and airway protection during the swallow. |
| Cortical Activation for Swallowing | From before onset of device use to return 3 months later | The level of cortical activation for swallowing was measured using near infra-red spectroscopy. Overall blood oxygenation level during swallowing was compared with the level during a non activation period prior to swallowing. To compute Z scores, the change in overall level between swallowing and prior to swallowing was divided by the standard deviation of the level prior to swallowing. The Z scores measured prior to and post device use for 3 months were compared. |
Countries
United States
Participant flow
Recruitment details
Potential patient participants were recruited from patients who had previously participated in protocol on The Passy Muir Swallowing Self Training Device, Voice and Swallowing Clinics, community hospitals, announcements in websites of patient support groups, and contacts with speech language pathologists specializing in dysphagia.
Pre-assignment details
Exclusion of those with psychiatric, epilepsy, severe speech/language communication disorders, cognitive impairment, esophageal disorders, and inability to tolerate a nasal endoscopic examination. Inclusion criteria: 13 years or older, parental consent if under 18, stable medical condition and oropharyngeal dysphagia.
Participants by arm
| Arm | Count |
|---|---|
| Laryngeal Vibrotactile Stimulation Participants with dysphagia received external laryngeal vibrotactile stimulation to trigger swallowing for swallowing retraining. Participants received training on the device and were then given a device to take home for 3 months.
Passy Muir Swallowing Self Trainer: External vibratory stimulation to the larynx to trigger swallow reflex in patients with dysphagia | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | no assistance for device training | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Laryngeal Vibrotactile Stimulation |
|---|---|
| Age, Continuous | 56.4 years STANDARD_DEVIATION 20.1 |
| Functional Oral Intake Scale 1-Severe | 6 Participants |
| Functional Oral Intake Scale 2-Moderate/Severe | 1 Participants |
| Functional Oral Intake Scale 3-Moderate | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 3 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Change in Dysphagia Outcome and Severity Scale (DOSS) Rating
An ordinal scale of 7 levels of severity of swallowing disorder with 1 being the lowest level and 7 being the highest level. Level 1 is Severe dysphagia Nothing per oral and unable to tolerate any per oral liquid/substance safely. Level 2 is Moderately severe dysphagia, requires maximum assistance or use of strategies with partial per oral only, tolerates at least one consistency safely with total use of strategies. Level 3 is Moderate Dysphagia, requires total assist, supervision, or strategies with two or more consistencies restricted. Level 4 is Mild-moderate Dysphagia, Requires intermittent supervision/cueing, one or two consistencies restricted level 5 is Mild dysphagia: requires distant supervision may need one diet consistency restricted Level 6 Within functional limits, modified independence Level 7 Normal in all situations
Time frame: From before onset of device use to return 3 months later
Population: Patients with Severe/Moderate to Severe dysphagia, chronic for more than 6 months, nutrition is by enteric means, may be able to ingest one consistencies with supervision
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Laryngeal Vibrotactile Stimulation | Change in Dysphagia Outcome and Severity Scale (DOSS) Rating | No change on DOSS | 5 Participants |
| Laryngeal Vibrotactile Stimulation | Change in Dysphagia Outcome and Severity Scale (DOSS) Rating | Improvement on DOSS | 2 Participants |
Comparison: Examined change in DOSS for each participant from before to after three months of device use. Examined numbers of participants who showed either worsening of DOSS, no improvement in DOSS or improvement of DOSS.p-value: <0.025Wilcoxon (Mann-Whitney)
Primary
Dysphagia Handicap Index (DHI)
Total handicap Score from 0 (no Handicap) to 100 (Severe Handicap)
Time frame: From before onset of device use to return 3 months later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Laryngeal Vibrotactile Stimulation | Dysphagia Handicap Index (DHI) | Pre Device use DHI score | 61.143 units on a scale | Standard Deviation 17.199 |
| Laryngeal Vibrotactile Stimulation | Dysphagia Handicap Index (DHI) | Post Use DHI Score | 38.571 units on a scale | Standard Deviation 22.501 |
p-value: 0.01695% CI: [6.003, 39.14]t-test, 2 sided
Secondary
Cortical Activation for Swallowing
The level of cortical activation for swallowing was measured using near infra-red spectroscopy. Overall blood oxygenation level during swallowing was compared with the level during a non activation period prior to swallowing. To compute Z scores, the change in overall level between swallowing and prior to swallowing was divided by the standard deviation of the level prior to swallowing. The Z scores measured prior to and post device use for 3 months were compared.
Time frame: From before onset of device use to return 3 months later
Population: Same patients before and after device use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laryngeal Vibrotactile Stimulation | Cortical Activation for Swallowing | 18.042 Z score | Standard Error 17.391 |
| After Device Use for 3 Months | Cortical Activation for Swallowing | 70.822 Z score | Standard Error 20.912 |
p-value: 0.03795% CI: [-100.751, -4.809]ANOVA
Secondary
Laryngeal Elevation Relative to Hyoid Elevation for Vestibule Closure
Calibrated kinematic measures from videofluoroscopic imaging during a modified barium swallow study. Computed the change in peak elevation in millimeters during swallowing from the rest position before swallowing for two structures: the larynx and the hyoid bone. The peak elevation of the two structures were compared by subtracting the hyoid peak elevation from the laryngeal peak elevation. If the measure was positive the larynx was elevated to a greater degree than the hyoid bone resulting in vestibule closure and airway protection during the swallow.
Time frame: From before onset of device use to return 3 months later
Population: Only 5 patients were able to undergo a repeated modified barium swallow study after device use.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laryngeal Vibrotactile Stimulation | Laryngeal Elevation Relative to Hyoid Elevation for Vestibule Closure | 5.525 millimeters | Standard Deviation 4.338 |
p-value: 0.046t-test, 2 sided