The Passy Muir Swallowing Self Training Device (PMSST)

James Madison University (JMU)

Status: Completed

Conditions: Oropharyngeal Dysphagia

Treatments: Device: Vibrotactile stimulation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01765673

R43DC012754

Details and patient eligibility

About

This is a device evaluation study to determine the optimal stimulation characteristics for using vibrotactile stimulation as a sensory triggering device for self retraining in patients with chronic moderate to severe dysphagia. Stimulation characteristics to be tested are frequency of vibration, pressure between the device and the skin, mode of vibration (pulsed or continuous).

Full description

Participants were recruited who had chronic moderate to severe dysphagia following stroke or radiation treatment for head and neck cancer. Their frequency of swallowing was transduced with an accelerometer placed on the skin over the thyroid cartilage and inductive plethysmography bands placed over the rib cage and abdomen. When laryngeal elevation coincided with respiratory apnea a swallow was marked. Five different motor frequencies were evaluated to determine their effect on participants frequency of swallowing (swallows per minute). Frequencies were 30, 70, 110, and 150 Hz and a combination of 70 and 110 Hz. For each vibratory frequency the number of swallows per minute occurring during stimulation was compared with sham when the participant was wearing the device but the motor was not turned on. The frequency fo swallowing during stimulation was compared with the frequency of swallowing between stimulations. Visual analogue ratings of the urge to swallow and discomfort were also measured after each condition. Other parameters were the pressure between the motor and the skin (0, 2, 4, and 6 kPa) and swallow initiation time when stimulation was on and when it was not. Swallowing frequency with continuous versus pulsed stimulation was also compared.

Enrollment: 13 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stroke or post radiation for the treatment of head and neck cancer
• Dysphagia with a score of 2 or greater on the Penetration/Aspiration Scale OR a Mann Assessment of Swallowing Ability ordinal risk rating of "probable" or "definite"

Exclusion criteria

• Neck injury
• Epilepsy
• Neurological disorder other than stroke
• Psychiatric illness other than depression
• Uncontrolled gastroesophageal reflux disease
• Inability to communicate secondary to significant speech or language problems
• Inability to maintain alertness for 1 hour
• Significant health concerns that would put the participant at risk

Trial design

13 participants in 1 patient group

Vibrotactile Stimulation in Dysphagia

Description:

A Vibrotactile stimulation device will be evaluated in patients with chronic moderate to severe dysphagia for more than 6 months post onset due to stroke or following radiation treatment for head and neck cancer to assess which frequency, mode, pressure characteristics are most helpful in increasing the rate of swallowing, increasing the urge to swallow, assisting with the initiation of swallowing and not affecting discomfort.

Treatment:

Device: Vibrotactile stimulation