Use of the Passy Muir Swallowing Self Trainer

Completed

Conditions studied: Stroke, Brain Injury, Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT02848664

Run by

James Madison University

People needed

11

Starts

2013-08-01

Expected to finish

2015-08-01

Last updated by the study team

2019-03-11

Who can join

Age: 13 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 13 years or older
• Stable medical condition
• Diagnosed with oropharyngeal dysphagia confirmed by Modified Barium Swallow (MBS) baseline measure of the follow two scales:
• Penetration-Aspiration Scale score of 2 or greater verified by modified barium swallow (Rosenbek et al., 1996) and/or
• 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.

You may not qualify if…

• 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

Where it is running

• James Madison University — Harrisonburg, Virginia, United States

Full record on ClinicalTrials.gov

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