Passy-Muir Swallowing Self Training Device to Enhance Recovery Post Stroke
Conditions: Oropharyngeal Dysphagia
Sponsor: James Madison University

Institutional Review Board (IRB) 
 
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James Madison University                                                                                                                                             
Last updated 10_3_13 
 
 
James Madison University 
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Responsible Researcher(s): Christy L Ludlow, PhD 
E-mail address: ludlowcx@jmu.edu 
Telephone: 540-568-3876 
Department: Communication Sciences and Disorders 
Address (MSC): 4304 
 
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Project Title: The Passy Muir Swallowing Self Training Device to Enhance Recovery Post 
Stroke 
 
Project Dates (Cannot exceed 1 year minus one day): 
 From:  08/01/12  
 
To:  07/31/13 
 
 
 
 
 
 
 
 
 
 
 
 
 
             MM/DD/YY              MM/DD/YY   
Minimum Number of Participants: 30 
Maximum Number of Participants: 45 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
External Funding:  
Yes: 
 
No: 
 
If yes, Sponsor: Passy Muir, Inc., subcontract from SBIR awarded by the National Institutes of Health 
 
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Name of Researcher(s) 
Training Completion Date 
Christy L. Ludlow 
06/05/2010 
Erin Kamarunas, PhD 
08/06/2013 
Carrie Jones, M.S. 
02/06/2013 
 
 
 
 
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Background and Objectives 
Patients with dysphagia have limited access to swallowing rehabilitation: Fifty percent of patients 
post stroke have swallowing difficulties with risk of aspiration7. If aspiration continues, with the passage 
of food or liquids through the larynx and into the lungs, it can cause an infection leading to pneumonia. 
Many hospitals screen acute stroke patients for risk of aspiration before allowing them to take 
medications and nutrition orally8. When there is evidence of aspiration, patients are designated nothing 
per oral (NPO) requiring a nasogastric tube for nutrition during acute hospitalization. Patients are 
referred to a speech pathologist to evaluate whether diet modification (use of thickeners) or 
compensatory strategies (head turn or chin tuck) will allow safe oral intake. Evidence on the 
effectiveness of these interventions is limited2. Hospital discharge post stroke is within days mostly to 
home (~50%), a skilled nursing facility (SNF ~25%) or inpatient rehabilitation (~20%)9. Before discharge 
those who are not able to swallow safely receive a percutaneous endoscopic gastrostomy (PEG) tube 
to support nutritional intake10, 11. Unfortunately recommendations for dysphagia management including 
therapy are often not included in discharge orders, limiting further care12. Subsequent access to 
rehabilitation is limited and patients’ swallowing problems are not further addressed unless they 
develop aspiration pneumonia and are re-admitted to hospital (estimated at 27%)11. Therefore, 
thousands of patients each year continue to have untreated dysphagia with reduced survival11, 
decreased quality of life and a lifetime of impaired nutrition. 
The Passy Muir Swallowing Self-Trainer  (PMSST) will Continue Swallowing Rehabilitation beyond 
Inpatient Status Without Additional Cost. This device and method for self training will allow patients with 
dysphagia to continue therapy in their own environment with the potential for recovery of safe 
swallowing. A speech pathologist will introduce the device and train the patient prior to discharge from 
hospital or inpatient rehabilitation so the patient can continue their therapy at home. Training will use 
small controlled amounts of water (~2-5ml) which have been shown to be safe13. Self retraining 
involves: 1) oral administration of a small amount of water, 2) the patient pressing a hand control to turn 
on sensory simulation, and 3) the patient immediately attempting a volitional swallow (Figure 2). Up to 
300 practice swallows occur each day; 60 are self training swallows when the patient uses the 
stimulator to practice volitional swallows while 240 swallows are provided during waking hours when 
the device cycles on automatically for a few seconds every 3 to 5 minutes to induce saliva swallowing.  
The significance of this home based patient-centered swallowing training is multi-dimensional. It will 
interrupt the usual cycle of recurrent aspiration leading to pneumonia and allow patients to regain oral 
nutritional intake after discharge to home. Patients on PEG tube feeding require costly care to maintain 
nutrition and prevent hospital readmissions due to aspiration pneumonia. Self training will overcome 
access and cost barriers to continued rehabilitation, allow patients to receive swallowing therapy long-
term, and enhance the speed and extent of recovery. With further worldwide increases in the aging 
population expected to accelerate health care costs, the reallocation of intensive rehabilitation to the 
patient in their environment, will increase recovery while reducing costs. This is in synchrony with world 
trends for patient-centered community based models providing a continuity of chronic care beyond 
hospitalization14.  
Purpose 
The purpose of this research is to define the optimal characteristics of the device to be developed 
prior to future research in Phase  2.  The purpose here is not to evaluate the usefulness of the self 
training device, that will be done in Phase 2.  In this Phase 1 study we are only trying to identify the 
optimal characteristics of the device to be developed before using it as a self training device in Phase 2. 
 
Procedures/Research Design/Methodology/Timeframe 

  
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Figure 4 Identification of swallows using accelerometry of laryngeal 
movement, sum signal of inductive plethysmography (ip), and the first 
derivative ip to identify swallow onset and offset, exhalation and the 
apneic period  
 
Figure 5. Display to patient training to provide 
stimulation onset within 500 ms before swallowing 
Research Design Aim 1:  
 
 
Subjects: Patients with dysphagia post stroke will be recruited from the VS-CRF and inpatient and 
outpatient admissions post stroke. The videofluoroscopic records of patients who volunteer will be 
reviewed to determine if they have a score of 2 or greater on the Pen-Asp scale47. Those without a 
videofluoroscopic study will receive the Mann Assessment of Swallowing Ability to identify those with a 
severity rating of “mild” or greater, that is a total numeric score of 177 or less 48, 49. If a nasoendoscopic 
evaluation of swallowing has been conducted, that will also be reviewed to determine if there is 
evidence of risk of aspiration50. (see Human Subjects protection). 
 i.Frequency Comparisons: 
Motors at frequencies of 30, 70, 
110, 150, and 70/110 Hz (using 2-
6 kPa neck pressure) will apply 8 s 
of stimulation followed by 15 s rest 
for a total of 28 stimulation trials for 
a total of 10.7 minutes per 
condition. Optionally, other hybrid 
motors similar to the 70/110 Hz 
motor may be used.  After a 
condition, the patient will mark on 
a visual analogue scale of 0 to 100 
mm their urge to swallow and their 
comfort level with stimulation for 
that condition. Online recordings of 
bi-axial accelerometry of laryngeal 
motion, inductive plethysmography 
of respiration, and digital video 
recordings will identify laryngeal 
movement and respiratory apnea 
to confirm swallows (Figure 4). Swallows cannot be identified during stimulation because of vibration 
interfering with the accelerometry signals, which necessitates video recording. The rate of swallowing in 
a 10.7 minute condition will be computed. The order of different frequencies will be counter-balanced 
across patients. Total testing time with rest periods will be 1 hour. If all the frequencies cannot be tested 
in the one hour time period, the remaining untested frequency (ies) can be completed at the end of 
another session if time allows, or the participants can attend additional sessions as needed. We expect 
that one frequency will be optimal across patients; if two frequencies are optimal we will combine them 
by using motors with different frequencies on each side. 
ii.Mode Comparisons: Using the optimal frequency(ies) identified, we will compare the effects of 
continuous versus the 4 Hz pulsed modes for 
10.7 minutes each in counter-balanced order 
across patients measuring the rate of swallowing 
and ratings of the urge to swallow to identify the 
most effective mode of stimulation.  
iii. Pressure Comparisons: Using the Iowa 
Oral Performance Instrument to measure strap to 
neck pressure and calipers to measure neck 
tissue fat, the effects of 2, 4, and 6kPa on rate of 
swallowing and urge to swallow with 8 s 
stimulation at the optimal frequency and mode of 
stimulation will be measured.  
iv. Stimulation Duration: We will determine 
the stimulation durations applied by patients when they are instructed to initiate swallowing during 
stimulation using the parameters identified for stimulation in i, ii and iii. The time required for them to 

  
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Figure 6. Points of potential introduction of a swallowing self re-
training methods and device to patients post CVA are in yellow. 
initiate swallowing after the onset of stimulation will be measured using air filled bellows wrapped 
around the neck to identify swallowing timing after stimulation onset (Figure 5). Air filled bellows are 
required as vibratory stimulation will interfere with accelerometry; we have used these bellows 
previously to identify swallowing in fMRI42. Additionally oral pressure sensor in using a small tube 
placed on the anterior tongue willmay be used to identify swallows. Neck calipers will measure tissue 
thickness in the throat area overlying the thyroid cartilage which may affect sensory input. When the 
participant has completed their final session, they will mark on a visual analogue scale of 0 to 100 their 
level of interest in using the self-training device at home for swallowing therapy.  
Expected Outcomes and Power Analyses: For each of the 4 experiments we will compare the mean 
visual analogue score and the mean swallowing rate within patients across conditions. Based on 
previous studies in healthy volunteers contrasting air puff stimulation on the rate of swallowing by 
Theurer et al.,38, 51, the expected change in rate of swallowing will be from 1.2 swallows/minute without 
stimulation to 2.0 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 patients needed will be 15 per experiment. Allowing for some patients to participate in 
several studies, we plan to recruit between 30 and 40 patients with risk of aspiration post stroke to 
participate in Aim 1 (see Human Subjects section).  
Potential Problems and Alternative Strategies: Anticipated problems include difficulties with 
recruiting an adequate sample of patients in the Harrisonburg area for testing in our clinic at RMH. Over 
412 patients were admitted to RMH acute post stroke in 2010 and the number is increasing each year 
while many more come for outpatient rehabilitation. We have 3 rooms in our JMU-RMH VS-CRF to 
support multiple patients being tested simultaneously. All equipment can be portable including 
Powerlab, a laptop, the amplifier system, the Kistler accelerometers and Inductive plethysmography so 
we can also test patients in rehabilitation and skilled nursing facilities throughout the Shenadoah valley. 
The 2011 Healthy Community Survey found that 20 percent of seniors in the Harrisonburg area have 
had a stroke out of an estimated 120,000 total population. Therefore access to 40 post stroke patients 
with dysphagia is feasible. In addition, we have developed a website, NetMedSLP, serving speech 
pathologists in medical settings throughout Virginia. This site provides continuing education to speech 
pahtologists specializing in dysphagia in 
Virginia. Over 2 dozen speech 
pathologists are registered and we intend 
to use this website to recruit collaborating 
speech pathologists for patient referral for 
our research studies. Further, Passy Muir 
employs 2 respiratory therapists in 
Virginia who can access speech 
pathologists to assist with patient 
recruitment. Future Directions These 
studies will be the basis for designing a 
prototype device for swallowing retraining 
by patients with dysphagia post stroke for 
Phase II.  
Aim 2. Identifying Delivery Points 
for Introducing Patients to Swallowing 
Self-training.  
Background The Passy Muir Swallowing Self-Training device is a novel approach to dysphagia 
rehabilitation. It requires that speech pathologists are willing to augment a patient’s rehabilitation by 
introducing a self-training device before discharge to home. As the majority of patients return home in 
the care of a family member post discharge9, the time before they are discharged is optimal for 
introducing a self re-training device as shown in Figure 6. Aim 2 is to obtain input from speech 
pathologists on the optimal time and method for introducing a swallowing self-trainer for patients with 
dysphagia post stroke. Speech pathologists’ input on the development of methods for patient 
introduction and training is needed prior to Phase II. Points of discharge to home, either from acute 

  
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care, skilled nursing or rehabilitation are time points to introduce a home based self-training system to 
patients who continue to have swallowing disorders post stroke. 
Will data be collected from or about any of the following populations? 
 
 
 Minors (under 18 years of age); Specify Age:   
 
 
 
 
 
 Prisoners 
 
 
 Pregnant Women 
 
 
 Fetuses 
 
 
 Cognitively impaired persons 
 
X  Other protected or potentially vulnerable population 
 
 
 Not Applicable  
 
 
 
Humans Subjects protections information 
 
Revised Human Subjects Protection for Aim 1:  Identifying the optimal stimulation 
characteristics for increasing swallowing in dysphagic participants  (Subcontract with James 
Madison University) 
 
Risks to Human Subjects 
a. Human subjects involvement, characteristics and design 
Participants in the subcontract at James Madison University will include up to 40 adults who have 
been diagnosed as having a swallowing disorder following a stroke. Based on the Harrisonburg Health 
Community Survey 2011, it is estimated that 20% of seniors have had strokes in the Harrisonburg 
community, 2/3 of who are male.  Figures from the U.S. Census 2011, and the Virginia Atlas 2005 
indicate that the population breakdown by race and ethnic categories are 78% Caucasian, 6% African 
American, 4% Asian, 16% Hispanic and 12% Other in the Harrisonburg area. We used these estimates 
in completing our enrollment table.   
 
The criteria for inclusion will include diagnosis of an oropharyngeal swallowing disorder 
(dysphagia) post stroke on instrumental examination including videofluoroscopy. We will limit 
recruitment to those persons who meet specific criteria for swallowing disorders based on published 
screening instruments (described below). We will recruit persons to come for screening or visit their 
home if that is more convenient for them. All participants will have had a modified barium swallow study 
within one year prior to participation in the study.  If a participant has had a videofluoroscopic 
examination within the last year and is stable we will review that examination or the description to 
determine if they would have a score of 2 or greater on the Pen Asp Scale1. This scale can be obtained 
from review of a videofluoroscopic examination and is the gold standard method of measurement of risk 
of aspiration. We will also use the Mann Assessment of Swallowing Ability (MASA) to screen for 
persons who continue to have dysphagia 2, recently found to have the highest sensitivity and specificity 
for identifying participants with aspiration on videofluoroscopy3. By including only participants with a 
Pen Asp score of 2 or greater or a MASA numerical score of 177 or less, only participants with mild or 
worse oropharyngeal dysphagia will be included in this research. A nasoendoscopic evaluation of 
swallowing may be administered if required for clinical care and ordered by a physician4. Participants 
will be carefully selected to only include those with some upper esophageal sphincter (UES) opening on 
videofluoroscopy to avoid including participants who would accumulate significant residue during the 
testing. Exclusions from the research will be participants with no UES opening, and other disorders 
such as traumatic brain injury, Parkinson disease, post head and neck surgery for cancer, 
chemoradiation for head and neck cancer, or a history of other events that could have affected 
neuromuscular innervation of the swallowing musculature such as coronary bypass, cervical spinal 
fusion or brain stem tumor excision. Participants with more than one stroke can be included. 
 
As the primary aim of this study is to gather participants’ feedback on their preferences regarding 
device characteristics regarding frequency of vibration, continuous versus pulsed modes of vibration, 
pressure of the device on the skin surface, and duration of stimulation, participants will need to be able 
to communicate their preferences to the investigators when they participate for one hour sessions in the 
hospital clinic. They will need to indicate their visual analogue scale ratings and communicate their 

  
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preferences verbally. Therefore, a speech pathologist will administer the Folstein Mini-Mental State 
Examination (MMSE) and require a score of 23 or greater for inclusion in the study.  We have 
previously found that this assures adequate understanding in participants in such a study. Any patient 
unable to meet these criteria will not be included in the research as they will not be able to provide 
accurate feedback and fully understand the purpose of the study. As only patients capable of 
understanding the purpose of the study and participating in the informed consent process, no 
permission will be obtained from a guardian or power of attorney.  
Assignment to Studies. Participants will be recruited into the studies planned for Aim 1 in the order 
that we conduct the studies. The first study, study i, will compare the effects of motors at frequencies of 
30, 70, 110, 150, 70/110 Hz, and other similar hybrid motors and measure the degree of urge to 
swallow, comfort level and frequency of swallowing during intervals following stimulation. To identify 
swallowing, noninvasive recordings will involve of bi-axial accelerometry of laryngeal motion, inductive 
plethysmography of respiration, and video recordings will identify laryngeal movement and respiratory 
apnea to confirm swallows. Total testing time for this first study will not exceed 1 hour; if a participant 
becomes fatigued we will stop the testing. Fifteen participants will be recruited and tested to evaluate 
different motor frequencies in study i. The testing for study ii comparing continuous versus pulsed 
stimulation will be conducted along with study iv determining how long stimulation is needed for a 
participant to initiate swallowing after stimulation, as these two studies combined will require about 1 
hour. These studies will also involve 15 participants, some of who may have participated in study i. 
Finally, study iii will also require no more than 1 hour and will compare the effects of different neck band 
pressures in 15 participants some of whom may have participated in studies i, ii or iv.  
We will try to accommodate participants’ needs and prevent fatigue or inconvenience by dividing up 
the testing conditions or conducting the testing in their home if they prefer. All of our equipment is 
portable, including suctioning, which will allow us to travel to the participants’ environments either at 
home, or in a nursing or rehabilitation setting. Only nasoendoscopy is restricted to the hospital 
environment and will only be conducted if ordered by a physician. 
During this Phase I SBIR research, the participants will not be using the device for swallowing 
training, rather they will only be asked to wear the device for short periods of 10 minutes and only saliva 
swallows will occur which normally occur throughout the day. Stimulation periods of 5-10s will occur 
intermittently over 10.7 minutes followed by a break when we will change devices. During breaks the 
most severely affected participants who have difficulty swallowing their saliva will either have their 
secretions suctioned or will expectorate their saliva into a cup. By suctioning as needed between 
stimulation periods, the participants’ secretions will be managed throughout the testing.   
 
b. Sources of materials. 
Online digitizing will use AD instruments Powerlab and Chart software to record accelerometry on 
the neck measuring laryngeal movement onset and offset, inductive plethysmography recordings of 
chest wall and abdominal respiratory movement to identify swallows along with the apneic period, and 
digital video recordings during each session to visually confirm swallows during data analysis. These 
recordings will be identified only by ID number and stored as Chart files for analysis on encrypted 
computers or the secure server in the laboratory at JMU accessible by VPN from laptops in the Voice 
and Swallowing Service. Analyses can also be conducted on workstations in the Laboratory of Neural 
Bases of Communication and Swallowing at JMU and only identified by ID code with no personnel 
health Information (PHI).  All video recordings, will be kept for 2 years on an encrypted computer and 
then destroyed. All deidentified case report forms will be kept for 2 years on a secure server and then 
destroyed.  
Participant visual analogue scale ratings of urge to swallow will be measured and entered into the 
data base. The responses will be identified by ID code with no PHI.  
c. Potential Risks 
There are only minimal risks to participants in this research. The Phase I studies for the SBIR are 
short term acute studies aimed at comparing the effects of different vibratory frequencies, pulsed and 
continuous stimulation modes, changes in neck pressure on participants’ frequency of swallowing, their 
initiation of swallowing and their ratings of urge to swallow during 3 or more short experiments lasting 
about 1 hour each. During this Phase I SBIR research, participants will not be using the device for 

  
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swallowing training.  Rather participants will only be asked to wear a device for short periods of 10 
minutes and provide feedback on their preferences. There are 4 short experiments and participants will 
be able if they choose to participate in one or more of the studies. The studies will require less than 1 
hour of time; a participant may choose to participate in one or more studies during a single visit and 
could likely complete all of four studies in three or more visits of no more than one hour each.   
This study will not involve giving participants any food or liquid to ingest,  Rather, the participants 
will only be swallowing their own saliva which they do in their daily living throughout the day. Therefore, 
the participants will not have increased risk as only saliva swallows will occur during the study which 
normally occur throughout the day. Therefore, these studies will involve only minimal risk to 
participants. The studies will be conducted by a licensed speech-language pathologist.  
We will take great care to make certain that all participants and their family or caregivers do not 
misinterpret the aim of the study as only to provide feedback on device preferences and that we will not 
be providing treatment for their swallowing disorder. It will be made clear to the participant and 
caregivers in study notices and advertisements, the informed consent and discussions. They will be told 
that the purpose of the study is only to gain feedback on a device that is being developed which will 
eventually be used for self training but that this study does not involve self training or treatment.  
Because certified and state licensed speech pathologists will be conducting the research they will 
provide participants and their caregivers with referral to patient services in their area for treatment of 
their swallowing disorder if appropriate.  
Many of the participants may have an ongoing risk of aspiration in their daily regimen because of 
their swallowing disorder. The speech pathologists will provide all participants and their family member 
or caregivers with advice on how to lessen their daily risk of aspiration. (see protections from research 
risks).   
Risk of loss of confidentiality will be prevented by following HIPAA regulations and further 
protections (see below).  
 
Adequacy of Human Subjects protection 
a. Recruitment and Informed Consent 
Participants will be recruited through the James Madison University (JMU) and Rockingham 
Memorial Hospital (RMH)  Voice and Swallowing Service, advertisements in the local newspaper, the 
Home Health Agencies of Rockingham Memorial Hospital and Augusta Medical Center, Harrisonburg 
Health and Rehabilitation Center, Rockingham Memorial Hospital Rehabilitation Center and community 
health care support groups in Harrisonburg including: The Health Place, Caregiver Chat Support 
Group, Friends and Relatives of Nursing Home Residents Support Group, and the Harrisonburg 
Community Health Center.  We will recruit persons from the Rockingham Memorial Hospital inpatient 
and outpatient services by placing advertisements in the waiting areas and asking professionals 
including neurologists, otolaryngologists and speech-language pathologists to place notices in their 
waiting and office areas. We will similarly ask the RMH Home Health Agency to distribute notices to 
persons receiving home health services post stroke. We will also place advertisements in both English 
and Spanish in the Harrisonburg Community Health Center, a local clinic.  Notices will also be mailed to 
professionals involved in stroke rehabilitation in the Shenandoah Valley area asking them to place 
notices in their waiting and office areas. We will only ask professionals to place notices and make 
literature available on our study but not to refer patients directly to us so patients will not feel under any 
undue influence from their caregiver professionals to participate. Our notices and literature will provide 
information that will allow participants to contact us directly.  
We are assured that we will be able to recruit between 30 and 40 participants in order to have 15 
participants in each of the 4 studies to reach adequate statistical power. Over 412 patients were 
admitted to RMH acute post stroke in 2010 and the number is increasing each year while many more 
come for outpatient rehabilitation. In 2012, the RMH became a recognized Stroke Care Center serving 
the Harrisonburg area of 120,000 persons. The 2011 Healthy Community Survey found that 20 percent 
of seniors in the Harrisonburg area alone have had a stroke out of the estimated 120,000 total 
population.  
We have 3 rooms in our JMU-RMH Voice and swallowing Service to support multiple participants 
being tested simultaneously. The burden to participants coming to our Service is small as they only be 

  
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asked to participate in 3 or more  visits for one hour each either in their home or at our outpatient 
service. Free parking is immediately available within 100 ft of the entrance to our testing rooms in the 
Treatment Center on the ground floor of RMH. 
All equipment can be portable including Powerlab, a laptop, the amplifier system, the Kistler 
accelerometers and Inductive plethysmography so we can also test participants in rehabilitation and 
skilled nursing facilities throughout the Shenadoah valley. Therefore access to 40 post stroke patients 
with dysphagia is feasible. In addition, we have developed a website, NetMedSLP, serving speech 
pathologists in medical settings throughout Virginia. This site provides continuing education to speech 
pathologists specializing in dysphagia in Virginia. Over 2 dozen speech pathologists are registered and 
we intend to use this website to notify speech pathologists of our research studies. Further, Passy Muir 
employs 2 respiratory therapists in Virginia who can assist with patient notification of the research. 
Administration of informed consent. Participants will be telephone screened and if they meet the 
inclusion criteria, they will be mailed the consent form for information purposes to allow them to review 
it before coming to the Voice and Swallowing Service. The consent will inform participants that Dr. 
Ludlow has a financial interest in the research. Either Dr. Ludlow or the speech-language pathologist 
will administer informed consent to the participant. During the consent process, either Dr. Ludlow or the 
Speech-Language pathologist will review the study with the participant and any family members 
present to answer questions. The participant will then read the consent and answer a few questions to 
demonstrate that they understood it. The consent will then be signed, witnessed and a copy given to 
the participant. Participants who have sight problems will have the consent read to them and a series of 
questions will be asked of all participants to assure their comprehension of the study before completing 
the informed consent process. No proxy consent or assent will be accepted for this study.  
 
b. Protections against risk 
As listed above under Potential Risks, this application is expected to involve only minimal increased 
risk from the research procedures in post stroke participants with swallowing disorders as only saliva 
swallows will be evaluated during the experiments. However, as a Phase I safety intervention trial, one 
purpose will be to determine the degree of risk encountered in patients as a result of device use while 
participating in the study.  All participants will normally be producing saliva and must swallow or 
expectorate their saliva throughout the day in their normal living. This risk occurs even when they are 
receiving enteral feeding either through a PEG tube or nasogastric tube.  
During the conduct of the device preference studies, speech pathologists will be recording and 
closely watching participants’ saliva swallows. To prevent aspiration of saliva by the participants during 
the device preference studies suctioning will be continually available to remove accumulated saliva 
from the oral cavity. Participants will be asked to phonate at regular intervals (every 10 -12 minutes) to 
detect secretions in the laryngeal vestibule. If the secretions can be heard while the participant is 
phonating, the participant will be encouraged to regurgitate their secretions into the oral cavity and the 
secretions will be removed with an oral swipe with a suctioning wand. 
All participants are expected to be at increased risk of aspiration in their daily living because of their 
swallowing disorder independent of the study. The speech pathologists conducting the testing for the 
research will provide all participants and their caregivers with usual guidance on a daily regimen to 
follow for preventing aspiration of their own secretions. Each participant will be taught a daily regimen 
of oral hygiene to minimize oral bacteria. Participants and their caregivers will be taught how to test 
voice quality during the day in order to detect a wet, gurgly voice quality which would indicate increased 
fluid in or around the airway.  They will be shown how to clear the airway by throat clearing, coughing 
and spitting into a cup and to clear the airway whenever they suspect increased fluid in or around the 
airway. All participants and their caregivers will be trained to monitor body temperature daily and 
contact the research staff if they have a rise in body temperature over three days sequentially while 
participating in the research. The medical officer for the project, who is not directly involved in the 
research, will evaluate pneumonia and other medical problems as they arise in participants in the 
research. It is expected that a participant will be enrolled in the study for about 1 month before being 
discharged from the study. 
If a participant has incidental findings while participating in the research, they will be referred to the 
medical officer, Ganesh Kini, MD, PhD, FACP, FHM, Medical Director, Hospital Division  at 

  
Last updated 10_3_13 
Rockingham Memorial Hospital. Dr. Kini will serve as the medical officer and will evaluate any medical 
problems as they arise in participants.  He will follow internal RMH hospital policies for incidental 
findings, e.g. providing referrals to specialists, and following state requirements for other incidental 
findings such as domestic abuse.  
During the device preference studies between 5-10 seconds of vibratory stimulation on the neck is 
applied for up to 28 times within 10.7 minutes for one frequency under the supervision of a speech-
language pathologist. Currently we are conducting this study in healthy volunteers in an IRB approved 
protocol classified as involving only minimal risk by the IRB at James Madison University and the IRB at 
Rockingham Memorial Hospital. We plan to follow the same procedures involving participants with 
swallowing disorders post stroke. . The different motors will only be administered to participants under 
the supervision of the speech-language pathologist during this SBIR Phase I. If the participant is judged 
to develop increased secretions that they cannot control by swallowing, suction equipment is available 
in each of the testing rooms of the Voice and Swallowing Service in the hospital to swipe suction to 
reduce secretions.  
If a participant has been designated “nothing per oral”, we will not be increasing their risk as we will 
not be administering food or liquid to participants during Aim 1 testing. We will only be measuring their 
attempts to swallow their own secretions during the study, which they all must attempt to do throughout 
the day regardless of PEG tube status. 
To protect confidentiality, a participant’s personal health information (PHI) will only be retained in a 
locked file cabinet in the Voice and Swallowing Service with the assigned participant ID code for this 
research protocol. The informed consents will be scanned into the Rockingham Memorial Hospital 
electronic medical records system. All other records, data recording and analysis documents will only 
contain the assigned Participant ID code for the research protocol. The Case Report Forms will only 
contain the ID code in LabTrack, an electronic notebook system used by Dr. Ludlow’s laboratory at 
JMU on a secure server that meets FDA requirements for data auditing. This system can only be 
accessed through VPN from laptops in the Voice and Swallowing Service.   
 
Potential Benefits of the Proposed Research to Human Subjects and Others 
The guidance that will be provided on how to prevent aspiration pneumonia may benefit participants 
who have not previously received this guidance. No immediate direct benefit will be provided to the 
participants in the research unless they have not previously had their swallowing disorder identified as 
they will receive an initial screening for oropharyngeal dysphagia by a speech-language pathologist.  
Such participants will be referred to the Medical Director of the JMU-RMH Voice and Swallowing 
Service for examination before they will be included in the research. Otherwise most participants will 
have previously been evaluated for a swallowing disorder and their participation will not provide them 
with direct benefit.  Participants will be compensated $20.00 for every experimental research session 
they participate in while enrolled in this study and will be reimbursed for travel mileage to offset the 
inconvenience of traveling to the Voice and Swallow Service, which participation requires.  
 
Potential benefits from this research are considerable for future patients with dysphagia following 
stroke.  Most patients with dysphagia post stroke do not continue to receive therapy after their 
discharge to home or a skilled nursing facility and are restricted in swallowing if they are at risk of 
aspiration pneumonia. The development of a self-training system will allow such patients to continue to 
receive therapy for their swallowing disorder after discharge from the hospital or a rehabilitation facility 
post stroke.  It is estimated that 300,000-600,000 persons exhibit some form of dysphagia per year due 
to neurological disorders5. 
 
Importance of the Knowledge to be Gained 
The research studies to be conducted under Aim 1 of this research will be the first step for 
determining how to optimize the proposed device characteristics for patient self-training.  An early 
version of the vibrotactile device that was used in the small patient study at NIH was developed to 
provide only sensory input during self-training for comparison with an intramuscular stimulation device 
that was surgically implanted and studied under an FDA IDE.  That study was recently completed and 
we found that the sensory and implanted devices had similar degrees of benefit during self-training.  

  
Last updated 10_3_13 
We have now decided to further develop the sensory input device as it is noninvasive and much less 
expensive for self-training.  This Phase I SBIR research will determine the optimal stimulation device 
characteristics before using the device in Phase II studies for eliciting swallowing during self-training in 
patients with oropharyngeal dysphagia post stroke.  
 
We have reviewed the FDA requirements for our device and it may qualify as a “Therapeutic 
massagers and vibrators 890.5975” under “Physical medicine devices” which are Class I 510(k) exempt 
devices. The IRBs that approved an ongoing study in healthy volunteers did not consider that an IDE 
was needed for use of this device.  
This device is undergoing development; the results of this Phase I trial will be the basis for the 
selection of the motor type(s), holder design, strap, frequency, mode and duration of vibration.  The 
engineers involved in the project will be developing the device to be used for Phase II using the results 
from this Phase I study.  
 
A related vibrotactile device was included as the control device in a small Phase II study evaluating 
the use of an intramuscular implant device for swallowing retraining between 2005 and 2009 (IDE 
G060153).  The vibrotactile device had comparable outcomes to the implant after 12 months of daily 
use by patients with dysphagia. Four patients used a vibrotactile device daily for swallowing retraining 
for a year without adverse events. 
 
We  will submit the protocol and human subjects consent submitted to the IRBs to the FDA for this 
study for use in post-stroke humans with dysphagia and await their decision regarding the need for an 
IDE or whether the device is Class I 510(k) exempt.  
 
Data Safety and Monitoring Plan 
 
Data integrity will be assured by using the LabTrack electronic notebook system in Dr. Ludlow’s 
lab which is on a secure backup server. This system meets FDA standards for data monitoring. Case 
Report Forms (CRF) will be setup with templates requiring entry of all essential data elements on each 
participant such as inclusion/exclusion criteria, consent records and records of visits, telephone 
contacts, and correspondence tracking each participant’s involvement in the research.  The LabTrack 
system tracks all entries, the date and the identity and any data changes by user ID.  All measures will 
be entered into data files on the Laboratory server by participant ID no.. The PI and speech pathologist 
will conduct monthly quality assurance reviews of the CRFs and data files. 
The outcome measures of participants’ preferences will include their swallowing frequency during 
10 minute periods containing short epochs of vibration to the neck area, swallowing onset times after 
stimulation onset and participant visual analogue scale ratings of their perceived urge to swallow during 
stimulation. Each of these data points will be measured from digitized Chart recordings and entered into 
data files by participant number in Labtrack and Excel.   
 
 
Data Safety Monitoring: 
 
 During each hourly visit with a participant, we will be testing for the accumulation of secretions in 
the upper airway by asking participants to phonate during breaks between devices every 10-12 
minutes. If a participant’s voice quality is judged by the speech pathologist to have a wet gurgly quality, 
we will instruct the participant to regurgitate into the oral cavity and then swipe suction the mouth. The 
CRF will include records of phonation testing at each break, the speech pathologist’s rating of the 
phonation and a record of whether oral suctioning was indicated and applied. All adverse events will be 
recorded during a test session in the CRF on encrypted Laptops connected by VPN to the LabTrack 
system on a server in Dr. Ludlow’s laboratory. Participants’ status at the end of each test session will 
be recorded in the CRF in LabTrack. 
 
Participants or their caregivers will be contacted within 2 days following a test session to record 
their status and any difficulties following testing. The findings will be recorded in CRFs in LabTrack. All 
participants in the project will be asked to take their body temperature daily and to contact the PI or 
speech pathologist if their temperature is elevated for 3 days in sequence while participating in the 
project. If a participant has had an elevated temperature for 3 days in sequence they will be scheduled 

  
Last updated 10_3_13 
to see the medical officer for the study, a Dr. Ganesh Kini, who is Medical Director of the Hospital 
Division at Rockingham Memorial Hospital, who will evaluate the patient. 
 
Records of adverse events (AE) will be evaluated by the medical officer, Dr. Kini, the Study 
Team and the JMU and RMH IRBs  for participants in the protocol and  submitted to the safety officer at 
NIDCD on a quarterly basis.  Serious adverse events (SAE) will be evaluated by Dr. Kini and reported 
to the IRBs at JMU and RMH and the NIDCD Safety Officer within 10 days of their occurrence.  
The IRBs will evaluate the reports of AEs/SAEs to determine if use of the device shows increased 
risk of aspiration pneumonia and other problems indicating that use of the device produces “more than 
minimal“ risk.   
ClincalTrials.gov requirements  
This is a Phase I safety intervention trial assessing participants’ preferences on various device 
characteristics. None of the participants will be using any of the devices for self-training or dysphagia 
therapy in this trial. As this study is not a treatment trial, participants may continue their usual regimen 
of dysphagia therapy while participating in the study.   
All participants will be monitored for AE/SAEs while participating in the study; it is expected that 
participants will undergo 3 or more visits of 1 hour each to provide feedback on the devices to the 
investigators over a 1-2 month period.  On completion of the experiments a participant will be 
discharged from the study.   
 
 
Human Subjects Protect ion for Aim 2: Identifying Delivery Points for Introducing Patients to 
Swallowing Self-training to be conducted by Passy Muir, Inc. 
 
We will apply to the JMU IRB to determine if the research to be conducted for Aim 2 qualifies  under 
Exemption 2 as exempt from the DHHS human subjects regulations the DHHS regulations as it only 
involves survey and interview procedures that do not involve (i) information obtained that is recorded in 
such a manner that human subjects can be identified, directly or through identifiers linked to the 
subjects; and (ii) any disclosure of the human subjects' responses outside the research that could 
reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial 
standing, employability, or reputation.   
 
 
 
References   
1. Robbins J, Coyle J, Rosenbek J, Roecker E, Wood J. Differentiation of normal and abnormal 
airway protection during swallowing using the penetration-aspiration scale. Dysphagia. Fall 
1999;14(4):228-232. 
2. Carnaby-Mann G, Lenius K. The bedside examination in dysphagia. Phys Med Rehabil Clin N 
Am. Nov 2008;19(4):747-768, viii. 
3. Gonzalez-Fernandez M, Sein MT, Palmer JB. Clinical experience using the mann assessment of 
swallowing ability for identification of patients at risk for aspiration in a mixed-disease population. Am J 
Speech Lang Pathol. Nov 2011;20(4):331-336. 
4. Langmore SE. Endoscopic evaluation and treatment of swallowing disorders. New York: Thieme; 
2001. 
5. Center EE-BP. Diagnosis and Treatment of Swallowing Disorders (Dysphagia) in Acute-Care 
Stroke Patients. Evidence Report/Technology Assessment No. 8. Vol AHCPR Publication No. 99-E024. 
Rockville, MD: Agency for Health Care Policy and Research; 1999. 
 
 

  
Last updated 10_3_13 
 
 
Where will research be conducted? (Be specific; if research is being conducted off of JMU’s 
campus a site letter of permission will be needed.)   
Rockingham Memorial Hospital in the JMU-RMH Voice and swallowing Service 
 
Will deception be used? If yes, provide the rationale for the deception:  
 
no 
What is the time frame of the study? (List the dates you plan on collecting data. This cannot be 
more than a year, and you cannot start conducting research until you get IRB approval.) 
 
September 1, 2012 
Data Analysis 
What methodology will be taken to ensure the confidentiality of the data (i.e., how and where data 
will be stored/secured, how data will be analyzed, who will have access to data, and what will happen 
to data after the study is completed?) 
 
  
Reporting Procedures 
Professionals in dysphagia 
 
 
 
Data Publication: Aim 1 will be published. 
 
 
 
Aim 1 Offered to have publications sent to them. 
 
 
 
Experience of the Researcher (and advisor, if student): 
Dr. Ludlow has conducted clinical research for over 35 years.  
 
 
 
 
 
 
 
 

  
Last updated 10_3_13 
     
The Passy Muir Swallowing Self Training Device to Enhance Recovery Post Stroke  
Consent to Participate in Research 
 
Identification of Investigators  
You are being asked to participate in a research study conducted by Dr. Christy Ludlow 
(Primary Investigator) from James Madison University, Department of Communication 
Sciences and Disorders. You will likely be seen at the JMU-RMH Voice and Swallowing 
Services office at RMH during this study. The JMU-RMH Voice and Swallowing Services is a 
collaborative project that includes both JMU and RMH. Dr. Ludlow is an inventor on the 
devices that will be tested as part of this research and could possibly benefit financially if the 
device becomes marketable.  
Dr. Ludlow receives her salary from James Madison University; The Passy Muir, Inc., 
reimburses James Madison University for a portion of her salary that is equivalent to the time 
she spends on research using funds received from the National Institutes of Health as  part of 
a small business innovative research grant.  
Purpose of the Study 
The purpose of this study is to learn whether or not using noninvasive and non-painful 
vibratory stimuli (like a cell phone) on the neck will change peoples’ swallowing. The findings of 
the study will contribute to our overall understanding of swallowing and could help people with 
swallowing disorders in the future, but the study does not provide a new treatment for you. 
Background 
Safe swallowing requires the ability to control when you swallow and to protect your airway.  
A chronic swallowing disorder (dysphagia) can be life threatening, as it can place patients at 
risk for aspiration of liquids and/or solids into the trachea. Repeated aspiration of substances 
into the lungs can result in pneumonia. We want to see whether certain types of vibratory 
stimuli might be used to help people to swallow who have had a stroke and have a swallowing 
disorder.  
 
Study Population 
Up to 50 persons who have had at least one stroke and have a swallowing disorder. 
 
Inclusion Criteria 
You may be eligible for this research study if: 
• You are 20 years old or older  
• You are in stable medical condition 
• You have had at least one stroke 
• You have a swallowing disorder based on the review of an examination of your 
swallowing using videofluoroscopy.  If you have not had such an examination of your 
swallowing in the last year and have previously had a swallowing disorder after a stroke we 
can arrange for you to have another videofluoroscopy that will be paid for by the research to 
assess your current swallowing status.  We can provide you with the results of this testing if 
you request it. 
• You will need to take a short pen and pencil test to assess your memory and cognitive 
skills to participate in the study.  We can provide you with the results of this testing if you 
request it. 

  
Last updated 10_3_13 
• We will be asking you some questions about your ability to eat food and swallow liquids.  
This questionnaire will assess whether you are at risk of having food enter your airway during 
swallowing.  We can provide you with the results of this testing if you request it. 
Exclusion Criteria 
Exclusionary criteria by participant report: 
• History of past brain injury, epilepsy, or neurological disorders (excluding stroke) 
• Previous neck injury 
• Psychiatric problems 
• Speech problems  
• Dementia, agitation, or a decreased level of alertness  
• Diagnosis of progressive neurodegenerative disorders, such as dementia, Parkinson’s 
Disease, multiple sclerosis, peripheral neuropathy, and amyotrophic lateral sclerosis 
 
Research Procedures 
Should you decide to participate in this research study, you will be asked to sign this 
consent form once all your questions have been answered to your satisfaction.  If you decide 
to participate in this study, you will be asked to participate in one or more studies (described 
below as Experiments, 1,2, 3 and 4) that we are conducting on different types of devices that 
we are assessing for future use with patients who have swallowing disorders.   
 
To measure the effects of each vibrator, we will attach a small vibrator to the outside of 
your throat with a band to hold it in place.  We will turn on a vibrator for different time periods 
such as 3 to 10 seconds, and then turn it off for between 15 to -40 seconds for up to 32 times.  
This may occur for up to 20 minutes at a time with short 2 minute rest period between testing 
different vibrators.  Thus, the total time for one condition may be just over 10 minutes. These 
sessions will test the following.  
 
Experiment 1: to identify an optimal speed of vibration 
  4 Vibrator Frequencies between 30 and 150 vibrations per second (30, 70, 110, and 150) 
and some combined vibrators will be tested in one session.   This will require one hour and 
may be divided between different testing times if it takes more than 1 hour of testing time. 
 
Experiment 2: to determine optimal pulsing rate 
   We will compare a pulsed vibrator and a continuous vibrator using one of the vibrators 
from Experiment 1. This should require less than 30 minutes of testing at a time.  
 
Experiment 3: to determine vibratory pressure settings and relationship with neck fat 
We will use a small balloon placed between the neck band and your neck to determine the 
effect of different pressure settings between the neckband and the neck which might increase 
the effect of the vibration using one of the vibrators we used in Experiment 1.  We will also 
measure the thickness of the skin overlying your neck with a caliper that has 2 arms. This 
should require less than 30 minutes of testing at a time. 
 
Experiment 4: To determine optimal automatic cycling rate:  
We will compare different times of vibratory stimulation to see which duration is needed for 
you to initiate swallowing: between 3, 5, 7 and 9 seconds.  Each trial will be approximately 10 
minutes, requiring about 1 hour of testing time. 

  
Last updated 10_3_13 
These experiments may be run on different days with you returning each day for three or 
more different visits. 
For each experiment, we will attach a small non-invasive sensor to the outside of your neck 
with tape (about the size of a pea) to record when you swallow.  We will also wrap bands 
around your rib cage and abdomen to measure your breathing. In some experiments you may 
have a tube placed on your tongue to record when you swallow.  
You will feel shaking to the throat when a vibrator is turned on, but this will not be painful or 
uncomfortable.  There will be periods when the vibrator is on and when it is off. Your saliva 
maybe suctioned if necessary. The suctioning would be done by a licensed speech 
pathologist.   
We will also ask you to say the vowel “eee” for about 10 seconds, two times with a vibrator 
turned on and two times without it turned on. This will tell us whether or not the vibration is 
reaching your voice box.  
Time Required 
Participation in this study will require approximately 3 hours total from consenting to and 
participating in the experiments. Some of the experiments may be combined, but we expect 
that to complete the entire groups of studies approximately 3-5 one hour visits will be required, 
but more can be scheduled as needed.   
Risks, Inconveniences and Discomforts 
 
We will be measuring the frequency that you swallow your saliva during some of these 
studies.  If you have difficulty swallowing you may find it difficult to swallow your saliva we may 
ask you to clear your throat and bring the saliva to your mouth so that we can suction it for you.  
We will test for increased saliva every 10 -12 minutes during the study.  If you normally have 
difficulty swallowing your saliva, please let us know and we will give you some advice on how 
to manage this.  
 
Many people who have swallowing problems are at a higher risk of developing pneumonia 
because of their swallowing problems. For that reason, while you are participating in this study 
we want you to take your temperature at the same time of day each day.  If your temperature 
is elevated from your normal levels by more than 2 degrees for 3 days straight you must call us 
so we can arrange for someone to see you in the next couple of days to see if you have a 
medical problem.   
 
We will contact you within 2 days after each test session to see if you are doing well.  
Please return our calls so that we can assure ourselves of your wellbeing. 
 
Vibrotactile Stimulation 
This is a non-invasive form of stimulation which carries no known risks. You will feel a 
vibration on your throat with the throat stimulator. 
 
Movement transducer device and Respitrace and video recording 
These are non-invasive and carry no known risks. The movement transducer device will be 
attached to the neck with tape which could cause brief skin irritation after removal. The 
Respitrace bands will be wrapped around your rib cage and abdomen during the experiment 
but should not cause any discomfort.  A small tube will sit on the front part of your tongue and 
will be held in place with tape at the chin/side of mouth. This tape could cause brief skin 

  
Last updated 10_3_13 
irritation after removal. A video recorder will record each session for later analysis and data 
verification. All records, including video recordings, will be kept for 2 years on an encrypted 
computer and the secure server and then destroyed. 
Benefits 
There are no direct benefits to you from participating in this research.  This is not a 
treatment study and you should continue any treatment or regimen that you are now following 
for management of your swallowing disorder. The results of this stimulation study will likely 
yield generalizable knowledge which might benefit others with dysphagia in the future.   
Confidentiality  
Your participation in this study is entirely confidential. All personally identifiable data will be 
kept in a locked and secure location that can only be accessed by authorized investigators. 
The results of this project will be coded in such a way that your identity will not be attached to 
the final form of this study. Your identity will be disassociated from your data and you will be 
assigned a participant number. The researchers retain the right to use and publish non-
identifiable data. The overall results of this research may be presented at professional 
conferences. You may sign a release form to obtain your results from this study and to allow 
use of your non-identifiable data for educational purposes here at JMU.  
Compensation 
You will be compensated $20.00 for every visit to the JMU/RMH Voice and Swallow 
Service for experimental research sessions while participating in this research study. For those 
patients without transportation to allow them to travel to the Rockingham Memorial Hospital we 
can offer to reimburse your transportation costs.  
 
Participation & Withdrawal  
Your participation is entirely voluntary. You are free to choose not to participate. Should 
you choose to participate, you can withdraw at any time without it affecting your current 
treatment or access to care for your swallowing disorder. The investigator can remove you 
from the study at any time if continuation is not in your best medical interest or if you are 
unable to follow the study requirements.  
 
Questions about the Study 
If you have questions or concerns during the time of your participation in this study, or after 
its completion or you would like to receive a copy of the final aggregate results of this study, 
please contact: 
 
Laboratory of Neural Bases of Communication and Swallowing, Dr. Christy Ludlow 
Communication Sciences and Disorders   
 
James Madison University 
 
 
 
 
Lab phone: (540) 568 - 5059  
 
 
Office Telephone:  (540) 568-3876 
ludlowcx@jmu.edu  
 
 
 
 

  
Last updated 10_3_13 
Questions about Your Rights as a Research Subject 
Dr. David Cockley  
Chair, Institutional Review Board 
James Madison University 
(540) 568-2834 
cocklede@jmu.edu 
 
Dr. Stewart Pollock 
Chair, Institutional Review Board 
RMH Healthcare 
540-689-1000 
 
Giving of Consent 
I have read this consent form and I understand what is being requested of me as a 
participant in this study. I freely consent to participate. I have been given satisfactory answers 
to my questions.  The investigator provided me with a copy of this form.  I certify that I am at 
least 20 years of age. 
______________________________________     
Name of Participant (Printed) 
 
______________________________________    ______________ 
Name of Participant (Signed)                                         Date 
______________________________________    ______________ 
Name of Researcher (Signed)                                       Date 
______________________________________    ______________ 
Name of Witness (Signed) 
 
 
            
 
 
   Date 
 
 
 
 

Institutional Review Board (IRB) 
 
Page 19 of 22 
James Madison University                                                                                                                                             
Last updated 10_3_13 
 
 
Medical History 
 
Name: _________________________________  Date of Birth:_____________________ 
Age:_______ 
 
Phone:___________________________________________________________________
________ 
(home)  
 
 
(cell)  
 
 
(work) 
Emergency Contact: 
_______________________Relationship:___________________Phone:__________ 
Do you have any history of: 
 Voice disorders (including laryngitis, loss of voice)?  
YES  NO 
If YES please list:____________________________________________________ 
Did you receive medical attention? ___ What was done? ____________________ 
Communication disorders?  
 
 
 
 
 
YES NO 
(Ex: Childhood speech or language problems) 
if YES please list:____________________________________________________ 
  Brain Injury?   
 
 
 
YES  NO 
(Ex: Car accident, sports injury) 
If YES please list:____________________________________________________ 
How many? __________Were you hospitalized?_________________________ 
Diseases/disorders?  
 
 
 
 
 
YES  NO 
(Ex: Parkinsons Disease, Lyme Disease, Multiple Sclerosis, Tumor, etc.) 
If YES please list:____________________________________________________ 
Stroke or Transient Ischemic Attacks (mild stroke)? 
 
 
YES NO 
If YES please list:____________________________________________________ 
Heart disease or heart attacks? 
 
 
 
 
 
YES  NO 
If YES please list:____________________________________________________ 
 
Do you currently have:   
Any diseases or disorders? 
 
 
 
 
YES  NO 
If YES please list:____________________________________________________ 
Allergies?  
 
 
 
 
 
 
YES NO 
If YES please list:____________________________________________________ 
 
Any additional relevant medical information? 
__________________________________ 

Institutional Review Board (IRB) 
 
Page 20 of 22 
James Madison University                                                                                                                                             
Last updated 10_3_13 
 
Release for Participant to Obtain Research Information 
 
I wish to receive my personal results from this study. I give permission for the investigators 
of the Voice and Swallowing Service   to release to me my personal data for my personal 
records. 
 
 
 
 I wish to obtain my data electronically via email.  
My email address is _____________________ 
 
 
 
 
I wish to obtain my data via US mail.  
My permanent address is _____________________________________ 
 
 
 
       _____________________________________ 
 
________________________________________ 
Name (Printed)  
 
Date 
 
 
________________________________________ 
Name (Signed)  
 
Date 
 
I do not wish to receive my personal results from this study. I do not give permission for 
the investigators of the Voice and Swallowing Service   to release me my personal data for my 
personal records. 
 
 
________________________________________ 
Name (Printed)  
 
Date 
 
 
 
________________________________________ 
Name (Signed)  
 
Date 

Institutional Review Board (IRB) 
 
Page 21 of 22 
James Madison University                                                                                                                                             
Last updated 10_3_13 
 
  
Release of Data for Educational Purposes 
 
I give permission for the investigators of the Voice and Swallowing Service   to use my 
individual data for educational purposes at James Madison University and professional 
conferences (Your data will NOT reveal any personally identifying information). Examples of 
such usages would include: graphs of your brain responses to different types of stimulation 
where you are only identified by a participant number or charts of your responses only 
identifying you by a participant number.  
 
________________________________________ 
Name (Printed)  
 
Date 
  
________________________________________ 
Name (Signed)  
 
Date 
 
I do not give permission for the investigators of the Voice and Swallowing Service to use 
my individual data for educational purposes at James Madison University and professional 
conferences 
  
________________________________________ 
Name (Printed)  
 
Date 
 
________________________________________ 
Name (Signed)  
 
Date 
 

Institutional Review Board (IRB) 
 
Page 22 of 22 
James Madison University                                                                                                                                             
Last updated 10_3_13 
  
 
 
Permission for Future Contact Release Form 
I, ______________________, have been informed and understand that 
______________________ in the Voice and Swallowing Service  and James Madison 
University is conducting a research study for the advancement of the field of speech-language 
pathology.  
 
Please choose from the following: 
 
I give ______________________________________ (investigators) permission for future 
contact. I wish to receive a copy of the research manuscript that will be submitted for 
publication. 
 
I am ______________________________________ (investigators) permission for future 
contact that may include thank you letters and advertisements for future studies. You may 
contact me via (Check any that apply): 
 
Email address:  _____________________ 
 
Mail to home address:  _____________________________________ 
 
            
          
  _____________________________________ 
Telephone number: _______________________________ 
 
________________________________________ 
Name (Printed)  
 
Date 
 
________________________________________ 
Name (Signed)  
 
 
Date 
 
I do not give ______________________________________ (investigators) permission for 
future contact. I do not wish to receive thank you letters, advertisements for future studies, or 
a copy of the research manuscript that will be submitted for publication. 
 
________________________________________ 
Name (Printed)  
 
Date 
 
________________________________________ 
Name (Signed)  
 
 
Date