- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01765673
The Passy Muir Swallowing Self Training Device (PMSST)
October 17, 2017 updated by: Christy Ludlow, James Madison University
Passy-Muir Swallowing Self Training Device to Enhance Recovery Post Stroke
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Virginia
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Harrisonburg, Virginia, United States, 22801
- James Madison University and Rockingham Memorial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants who have swallowing problems secondary to a stroke or following radiation for the treatment of head and neck cancer
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Vibrotactile Stimulation in Dysphagia
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.
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Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow.
Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration.
Each session will last no more than 1 hour with short breaks.
Each participant can volunteer for up to three nonconsecutive sessions.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Swallow Frequency 30 Hz
Time Frame: During one session within 1 hour
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Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)
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During one session within 1 hour
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Change in Swallow Frequency 70 Hz
Time Frame: During one session within 1 hour
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Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)
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During one session within 1 hour
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Change in Swallow Frequency 110 Hz
Time Frame: During one session within 1 hour
|
Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)
|
During one session within 1 hour
|
Change in Swallow Frequency 150 Hz
Time Frame: During one session within 1 hour
|
Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)
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During one session within 1 hour
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Change in Swallowing Frequency 70 & 110 Hz
Time Frame: During one session within 1 hour
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Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)
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During one session within 1 hour
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Urge to Swallow After 30 Hz Stimulation
Time Frame: During one session within 1 hour
|
At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible.
The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.
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During one session within 1 hour
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Change in Urge to Swallow 70 Hz
Time Frame: During one session within 1 hour
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At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible.
The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.
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During one session within 1 hour
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Change in VAS Urge to Swallow 110 Hz
Time Frame: During one session within 1 hour
|
At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible.
The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.
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During one session within 1 hour
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Change in VAS Urge to Swallow 150 Hz
Time Frame: During one session within 1 hour
|
At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible.
The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.
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During one session within 1 hour
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Change in VAS Urge to Swallow 70 & 110 Hz
Time Frame: During one session within 1 hour
|
At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible.
The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.
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During one session within 1 hour
|
Change in Discomfort Level 30 Hz
Time Frame: During one session within 1 hour
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At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible.
The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.
|
During one session within 1 hour
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Change in Discomfort 70 Hz
Time Frame: During one session within 1 hour
|
At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible.
The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.
|
During one session within 1 hour
|
Change in Discomfort 110 Hz
Time Frame: During one session within 1 hour
|
At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible.
The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.
|
During one session within 1 hour
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Change in Discomfort 150 Hz
Time Frame: During one session within 1 hour
|
At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible.
The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.
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During one session within 1 hour
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Change in Discomfort 70 & 110 Hz
Time Frame: During one session within 1 hour
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At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible.
The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.
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During one session within 1 hour
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Change in Swallowing Frequency 2 kPa
Time Frame: During one session within 1 hour
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The pressure between the neck band and the skin was set and the changes in swallowing frequency was compared between pressure between increased pressure and no pressure condition
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During one session within 1 hour
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Change in Swallow Frequency 4 kPa
Time Frame: During one session within 1 hour
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The pressure between the neck band and the skin was set and the changes in swallowing frequency was compared between pressure between increased pressure and no pressure condition
|
During one session within 1 hour
|
Change in Swallow Frequency 6 kPa
Time Frame: During one session within 1 hour
|
The pressure between the neck band and the skin was set and the changes in swallowing frequency was compared between increased pressure and no pressure condition
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During one session within 1 hour
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Percent Change in Swallow Frequency Pulse vs Continuous
Time Frame: During one session within one hour
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Percent Change= [(Number of swallows per minute from continuous stimulation -number of swallows per minute during pulsed stimulation) / number of swallows per minute during pulsed stimulation] X 100
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During one session within one hour
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Change in Swallow Initiation Time
Time Frame: During one session within 1 hour
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Change in swallow initiation time (ms) from swallow reaction time during vibrotactile stimulation minus reaction time with sham (no) stimulation
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During one session within 1 hour
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Christy L Ludlow, PhD, James Madison University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Theurer JA, Bihari F, Barr AM, Martin RE. Oropharyngeal stimulation with air-pulse trains increases swallowing frequency in healthy adults. Dysphagia. 2005 Fall;20(4):254-60. doi: 10.1007/s00455-005-0021-1.
- Theurer JA, Czachorowski KA, Martin LP, Martin RE. Effects of oropharyngeal air-pulse stimulation on swallowing in healthy older adults. Dysphagia. 2009 Sep;24(3):302-13. doi: 10.1007/s00455-009-9207-2. Epub 2009 Apr 24.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
February 22, 2016
Study Completion (Actual)
February 22, 2016
Study Registration Dates
First Submitted
January 8, 2013
First Submitted That Met QC Criteria
January 8, 2013
First Posted (Estimate)
January 10, 2013
Study Record Updates
Last Update Posted (Actual)
November 14, 2017
Last Update Submitted That Met QC Criteria
October 17, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R43DC012754 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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