Nervous System Diseases

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Stroke

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Head and Neck Neoplasms

Deglutition Disorders

Brain Diseases

Central Nervous System Diseases

Craniocerebral Trauma

Trauma, Nervous System

Participants with dysphagia received baseline testing of dysphagia and dysphagia handicap. Then received training on how to use a vibrotactile device for self training at home. They used the device for 3 months and returned for re-evaluation on testing of dysphagia and feedback on the 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

Dysphagia retraining with device

Erin Kamarunas, PhD

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.

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.

Use of the Passy Muir Swallowing Self Trainer

Study of the Use of the Passy Muir Swallowing Self Trainer by Persons With Dysphagia

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

Total handicap Score from 0 (no Handicap) to 100 (Severe Handicap)

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.

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.

Passy Muir Inc.

James Madison University

Professor

Severe Adverse Event: Diagnosis of Aspiration Pneumonia

Patients using vibrotactile device over 3 months at home while practicing swallowing and to manage salivary by swallowing during waking hours

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

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

There are 7 levels of oral intake that are assigned by the examiner based on patient and caretaker reports or oral intake. These 7 levels are

1. Nothing by mouth (Severe)
2. Tube dependent with minimal attempts at food or liquid (Moderate/Severe)
3. Tube dependent with consistent oral intake (Moderate)
4. Total oral diet of a single consistency
5. Total oral diet with multiple consistencies, requiring special preparations or compensations
6. Total oral diet with multiple consistencies, without requiring special preparation, with specific limitations
7. Total oral diet no restrictions

Functional Oral Intake Scale

Dr. Erin Kamarunas

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.

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

Change in Dysphagia Outcome and Severity Scale (DOSS) Rating

Pre Device use DHI score

Post Use DHI Score

Participants with dysphagia received external laryngeal vibrotactile stimulation to trigger swallowing

Dysphagia Handicap Index (DHI)

Patients using vibrotactile device over 3 months at home while practicing swallowing and to manage salivary flow by swallowing during waking hours

Only 5 patients were able to undergo a repeated modified barium swallow study after device use.

Laryngeal Elevation Relative to Hyoid Elevation for Vestibule Closure

Baseline evaluation before receiving a device

Baseline Before Device Use

After vibrotactile device over 3 months at home for practicing swallowing and to manage salivary flow by swallowing during waking hours

After Device Use for 3 Months

Same patients before and after device use

Cortical Activation for Swallowing

Participants with dysphagia received an external laryngeal vibratory stimulation device, The Passy Muir Swallowing Self Trainer, to assist with swallowing retraining. Participants and their caregivers received training to criterion on how to use the device and were then given a device to take home for 3 months for daily use in swallowing training and for saliva swallowing throughout the day. They were asked to use the device for a minimum of 60 practice trials of swallowing their own and to wear the device to assist with saliva swallowing. All participants were evaluated on their swallowing using modified barium swallow examination and patient questionnaires immediately before device training and on return 3 months later. They also completed questionnaires on the device characteristics on return.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Use of the Passy Muir Swallowing Self Trainer	NCT02848664	Stroke Brain Injury Head and Neck C...	Dysphagia retra...	13 Years - 100 Years	James Madison University
Use of the Passy Muir Swallowing Self Trainer	NCT02848664	Stroke Brain Injury Head and Neck C...	Dysphagia retra...	13 Years - 100 Years	James Madison University

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