The Passy Muir Swallowing Self Training Device to Enhance Recovery Post Stroke (PMSST)

This study is currently recruiting participants.
Verified February 2013 by James Madison University
Sponsor:
Collaborator:
Passy Muir Inc.
Information provided by (Responsible Party):
Christy Ludlow, James Madison University
ClinicalTrials.gov Identifier:
NCT01765673
First received: January 8, 2013
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to develop a vibratory self-trainer for the treatment of dysphagia post-stroke.

The aim is to identify the optimal stimulation characteristics for use with participants with swallowing problems including:

  • Frequency of vibration
  • Mode of vibration either continuous or pulsed
  • Pressure of device against the neck
  • Duration of vibration to allow a participant to initiate a swallow

Condition Intervention
Dysphagia
Stroke
Device: Passy Muir Swallowing Self-Trainer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pass-Muir Swallowing Self Training Device to Enhance Recovery Post Stroke

Resource links provided by NLM:


Further study details as provided by James Madison University:

Primary Outcome Measures:
  • Frequency of swallowing [ Time Frame: During intervention. Each experimental session will last no more than 1 hour, participants can volunteer for 1-3 sessions. ] [ Designated as safety issue: No ]
    Outcome measure for Aim 1. Frequency of swallowing and time to initiate a swallow with stimulation will be measured to determine optimal stimulation characteristics of the vibratory device.


Secondary Outcome Measures:
  • Perceived urge to swallow [ Time Frame: During intervention. Each experimental session will last no more than 1 hour, participants can volunteer for 1-3 sessions. ] [ Designated as safety issue: No ]
    Outcome measure for Aim 1. Participants will mark on a VAS scale their perceived urge to swallow to determine optimal characteristics of the vibratory self-trainer.


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants with swallowing deficits post stroke Device: Passy Muir Swallowing Self-Trainer
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:
  • PMSST
  • Swallowing Self-Trainer

Detailed Description:

This study investigates the use of self-training device to improve swallowing post-stroke. The device has motors placed on the neck over each side of the thyroid cartilage and provides noninvasive vibratory stimulation. The vibration penetrates through the neck to the tissues in the larynx to activate mechanoreceptors innervated by the internal branch of the superior laryngeal nerve, which when stimulated will trigger swallowing at the brain stem level. The outcomes of this research will be used to develop a device for use by the patients for daily swallowing self-training in their own environment.

Site monitoring and auditing will be conducted at crucial time points during the study, including just prior to participant enrollment. Auditing will be conducted by Julie Kobak, Vice President for Clinical Education of Passy Muir , Inc.

Source data verification will be comparing raw data forms to electronic case report forms.

Standard operating procedures are in place for participant recruitment, data collection, data management, data analysis, and reporting adverse events.

Sample size assessment: Based on previous studies in healthy volunteers contrasting air puff stimulation on the rate of swallowing (1, 2) the expected change in rate of swallowing will be from 1.2 swallows/minute without stimulation to 2.0 swallows/minute with stimulation with a standard deviation of the differences being 0.9. Using a Bonferroni corrected alpha of 0.025 (to test 2 measures) at 0.80 power with an effect size of 0.88, the number of participants needed will be 15 per experiment. Allowing for some participants to participate in several studies, the investigators plan to recruit between 30 and 40 participants with risk of aspiration post stroke.

Potential problems and alternative strategies: Anticipated problems include difficulties with recruiting an adequate sample. There are 3 rooms available for participant testing at Rockingham Memorial Hospital to support multiple participants being tested simultaneously. Furthermore, all the equipment is portable including Powerlab, a laptop, the amplifier system, the Kistler accelerometers, and Inductive plethysmography so participants can be tested in rehabilitation settings and/or in their own home. Advertisements and a website have also been created.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants who have swallowing problems secondary to a stroke..

Criteria

Inclusion Criteria:

  • Stroke
  • 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:

  • Head injury
  • Head and neck cancer
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765673

Contacts
Contact: Erin E Kamarunas, PhD 540-568-8846 kamaruee@jmu.edu
Contact: Christy L Ludlow, PhD 540-568-3876 ludlowcx@jmu.edu

Locations
United States, Virginia
James Madison University and Rockingham Memorial Hospital Recruiting
Harrisonburg, Virginia, United States, 22801
Contact: Christy Ludlow, PhD    540-568-3876    ludlowcx@jmu.edu   
Sub-Investigator: Erin E Kamarunas, PhD         
Sponsors and Collaborators
James Madison University
Passy Muir Inc.
Investigators
Principal Investigator: Christy L Ludlow, PhD James Madison University
  More Information

Publications:
Responsible Party: Christy Ludlow, Professor, James Madison University
ClinicalTrials.gov Identifier: NCT01765673     History of Changes
Other Study ID Numbers: R43DC012754
Study First Received: January 8, 2013
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by James Madison University:
Swallowing
Dysphagia
Stroke
Sensory stimulation
Home based therapy

Additional relevant MeSH terms:
Deglutition Disorders
Stroke
Cerebral Infarction
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 16, 2014