Sex and Age Ultrasound Response to Differential Jugular Vein Pressure
Phase: NA
Conditions: Concussion, Mild
Sponsor: Children's Hospital Medical Center, Cincinnati

STUDY TITLE:  Sex and Age Ultrasound Response to Differential Jugular Vein Pressure 
 
IRB#: 2016-8580 
NCT#: NCT03017937 
Approval Date: 11/22/2016 
 
 
 

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CINCINNATI CHILDREN’S HOSPITAL MEDICAL CENTER  
 
 
STUDY TITLE:  Sex and Age Ultrasound Response to Differential Jugular Vein Pressure  
 
 
 
INVESTIGATOR INFORMATION: 
 
Gregory D. Myer, PhD 
 
(513) 636-0249 
 
(513) 636-0249 
Principal Investigator Name           Telephone Number             24 hr Emergency Contact 
 
CO-INVESTIGATORS:     
Kim Barber Foss 
 
 
 
 
 
 
(1) ABSTRACT:  
Significant morbidity, mortality, and related costs are caused by traumatic brain injury (TBI). A 
simple, effective, and lightweight device worn by athletes or war fighters in the field, designed to 
mitigate TBI resulting from blast trauma or concussive events, would save lives, and the huge 
costs currently being experienced for life-treatment of surviving victims.  An externally-worn 
medical device (the Device) that applies mild jugular vein compression according to the principle 
of the Queckenstedt Maneuver, is being developed by Q30 Sports Science, LLC (Q30). 
Preliminary research suggests that the Device has the potential to reduce the likelihood of TBI. 
The currently developed collar (Smith 2009, Smith and Fisher 2011, Smith and Fisher 2011, Smith 
2012) has been approved for studies in humans (IRB 2013-2240) and the results indicate safety 
for use during high demand and maximal exertion activities. Regarding safety, the externally worn 
collar is meticulously designed to mimic the body’s own omohyoid muscle actions upon the 
jugular veins that will provide similar pressure and volume increases not to surpass that of a yawn 
or the mere act of just lying down. Initial safety testing and early clinical trials indicate that the 
collar application is both safe and efficacious to prevent brain microstructure and 
neurophysiological changes in response to head impacts. 
 
(2) PURPOSE:   
Clinical trials have suggested that this device is effective in mitigating changes in brain structure 
and function in athlete populations.  The purpose of the current study is to measure the response 
of the jugular vein to various pressures applied by a generic compression device across various 
ages and gender.  The relative jugular vein response will be measured using ultrasound. 
 
(3) BACKGROUND:  
The Device has the promise of providing a novel mechanism for reducing or preventing the 
likelihood of TBI, and may be used in conjunction with other protective equipment. TBI is the 
leading cause of death in individuals under age 45. The cost of TBI in the U.S. is estimated at 
anywhere from $50 to $150 billion, annually. Concussion in female high school soccer players have 
been noted to occur at a rate of 4.5 concussions per 10,000 athletic exposures (Comstock, Currie 
et al. 2015).  We propose that Slosh Theory can explain these differences offering a mechanistic 
approach that could help shed light on further ways to alleviate the TBI burden on society.  Note 

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that Slosh Theory teaches us that hydrodynamics (fluids moving within moving containers) 
contribute to, or are even the main etiology for, energy absorption of the cranial contents and that 
mitigation of SLOSH (increased compensatory reserve volume) may mitigate TBI. 
 
According to NASA, “The oscillation of a fluid caused by an external force, called sloshing, occurs 
in moving vehicles containing liquid masses, such as trucks, etc.” This oscillation occurs when a 
vessel is only partially filled. It is hypothesized that the brain faces similar slosh energy absorption 
during external force impartation.(Turner, Naser et al. 2012) Slosh permits external energies to be 
absorbed by the contents of a partially filled vessel or container by means of inelastic collisions. 
Tissues of differing densities can decelerate at different rates creating shear and cavitation. If the 
collisions between objects or molecules are elastic, the transfer of energies to those objects 
diminishes, minimizing the energies imparted by slosh.(Smith, Bailes et al. 2012)  
 
Woodpeckers, head ramming sheep and all mammals (including humans) have small, little known 
and misunderstood muscles in their necks called the omohyoid muscles. Highly G-tolerant 
creatures of the forest have utilized these muscles to gently restrict outflow of the internal jugular 
veins thereby “taking up” the excess compliance of the cranial space and ultimately protecting 
themselves from TBI like tiny “airbags” in a motor vehicle. Rat studies by have demonstrated that 
we can easily and safely facilitate this muscle’s actions by a well-engineered gentle compression 
over those muscles.(Smith, Bailes et al. 2012, Turner, Naser et al. 2012) 
 
The medical Queckenstedt Maneuver devised to detect 
spinal cord compression, gently places pressure over the 
external jugular veins to increase cerebral spinal volume and 
pressure. In this maneuver, the veins are compressed while 
a lumbar puncture monitors the intracranial pressure. 
“Normally, the pressure rise to the higher ‘plateau’ level 
occurs instantly upon jugular compression to fall again 
equally fast upon release of the compression”(Gilland, Chin 
et al. 1969). This incredibly simple principle can be employed to protect soldiers and athletes from 
TBI by safely, and reversibly, increasing intracranial volume and pressure. The neck collar device 
is made of Outer collar - hytrel (thermoplastic elastomer), Inner collar - TPSiV (thermoplastic 
elastomer), metal insert (stainless steel), and is fitted to the neck to provide a comfortable and 
precise jugular compression that potentially mitigates cerebral slosh (Figure 1).   
 
Although the skull, blood, and brain are “almost incompressible,” the vasculature tree of the 
cerebrum is quite reactive and compressible. As volume is added to the cranium, eventually the 
compensatory reserve volume is surpassed and the intracranial pressure increases slightly. 
Increasing cerebral blood volume by just 1-3% safely and reversibly reduces compliance of the 
cerebral vascular tree and diminishes absorption of slosh energies. Jugular compression increases 
cerebral blood volume almost instantaneously. As mentioned, this degree of increase has 
significantly mitigated slosh and TBI in laboratory animals and mimics the highly concussion 
resistant wild animals that are able to reflexively increase cerebral blood volume through natural 
jugular compression. 
 

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A landmark article, published in the Journal of Neurosurgery, used a standard acceleration-
deceleration impact laboratory model of mild TBI. The study showed a successful and marked 
reduction of axonal injury following Internal Jugular Vein (IJV) compression as indicated by 
immunohistochemical staining of Amyloid Precursor Proteins (APP) (Smith, Bailes et al. 2012, 
Turner, Naser et al. 2012). It is argued that IJV compression reduces slosh-mediated brain injury 
by increasing intracranial blood volume and reducing the compliance and potential for brain 
movement within the confines of the skull. The potential for such technique to mitigate both linear 
and rotational brain injury in humans by “internal protection” represents the most novel approach 
to mitigating TBI. Initial safety testing and early (pre) clinical trials (detailed below) indicate that 
the collar application is both safe and efficacious to prevent brain microstructure and 
neurophysiological changes in response 
to head impacts. These data create the 
impetus better understand the jugular 
vein’s response to collar application. 
Relative to the proposed investigation 
we have compared the ultrasound 
response to the standard collar in high 
school female and male athletes and 
have not seen a sex specific response. 
We are interested to learn more about 
the relative responsive of different ages 
and sex to the collar application and to 
determine 
the 
minimum 
relative 
pressure that is required to invoke the 
jugular vein response. 
 
 
Summary of Prior Work 
 
A. Safety testing in athletes has been approved by the local IRB and was completed in the 
Cincinnati Children’s Hospital Human Performance Laboratory (Study ID: 2013-2240; PI: 
Gregory Myer). Evaluation of monitored vital signs, biomechanics, cardiorespiratory capacity, 
postural control, dynamic stabilization, reactive index, concentration and cognition, memory, 
strength and power in a population of athletes showed no statistically significant adverse effect of 
wearing a mild jugular vein compressive neck collar compared to a sham arm band.(Myer, 
Edwards et al. 2013) Cumulatively, the pre and post safety measures indicate that neurologic 
parameters of executive function, eye hand coordination, balance, memory and reaction times were 
unchanged following two hours of physical testing wearing the collar prototype. Acceptance of 
the compression collar was not different in physiological biomarker response to the non-collared 
condition during maximal oxygen uptake and maximum effort power testing.(Myer, Edwards et 
al. 2013) 
 
 
B. Magnetic Resonance Elastography was established at CCHMC in collaboration with The 
Mayo Clinic to support these studies (IRB: 2013-2240). Under jugular vein compression with the 
collar, all participants tolerated the procedure without any untoward effects. The preliminary 
studies of dynamic shear strain showed no consistent pattern of wave propagation and elasticity 
placed upon the vascular and cranial tissues. Analysis of these data continues.  

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C. We studied 410 participants (ages 12 to 68 years of age) via a middle ear power analysis 
(MEPA) with and without the compression collar, and no complaints or untoward effects were 
noted and no decline in the auditory perception was recorded. The expected changes of reduced 
Acoustic Reflectance of the inner ear and middle ear (indicative of reduced compliance) were 
noted only in subgroup analysis of those with jugular vein compression. The results of this study 
indicate that the neck compression collar prototype may have the potential to safely reduce energy 
impartation into cranial structures (i.e., the inner ear); however, further work is needed with 
advanced collar designs to establish this effect. 
 
 
D.  fMRI and CO2 reactivity was performed on 12 adults before and after application of jugular 
vein compression. Results comparing before and after jugular vein compressions (with the collar) 
yielded no alterations in O2 uptake or glucose metabolism to any portion of the brain.(Fisher, 
Duffin et al. 2013). 
 
 
E. An in vivo clinical trial was approved by CCHMC IRB and was completed in the 
Cincinnati Children’s Hospital Human Performance Laboratory and Radiology Department (Study 
ID: 2014-5009; PI: Gregory Myer) An in vivo clinical trial was performed in hockey players of the 
proposed intervention device used during sporting competitions to test its effect in ameliorating 
neuroanatomical and neurophysiological changes to the brain using two widely accepted 
techniques [diffusion tensor imaging (DTI), and event related potentials (ERPs) utilizing 
electroencephalography.](Reches, Laufer et al. 2014) For athletes in the non-intervention group, 
radial diffusivity (RD, DTI parameter associated with white matter structural integrity(Song, Sun 
et al. 2003, Song, Yoshino et al. 2005)) increased significantly from pre-season to mid-season. By 
comparison, the athletes in the intervention group did not show a significant change in RD with 
similar accumulated g-force head impacts. In kind, ERP analysis showed concomitant changes in 
brain network dynamics in the non-intervention group—the level of change was strongly 
correlated with the accumulated g-force of the collisions, whereas the intervention group showed 
no significant change. These group differences indicate that mild jugular vein compression may 
provide protection from the detrimental effects of collisions and resultant brain injury. These 
prospective longitudinal data utilized an internal (in vivo) approach and demonstrate that it is 
possible to protect the brain from sports related head impacts.  
 
 
F. An in vivo clinical trial was approved by CCHMC IRB and was completed in the Cincinnati 
Children’s Hospital Human Performance Laboratory and Radiology Department (Study ID: 2015-
2205; PI: Gregory Myer). The in vivo clinical trial was performed in football players implementing 
the proposed intervention device used during sporting competitions to test its effect in ameliorating 
neuroanatomical changes to the brain using evidenced by diffusion tensor imaging (DTI), Based 
on pre-clinical data we hypothesized that collar imparted jugular compression that minimally 
restricts venous outflow to encourage cerebral venous sinus engorgement would reduce brain 
injury biomarkers in athletes exposed to head impacts during a competitive football season. This 
project utilized a prospective controlled trial to evaluate effects of mild jugular vein (i.e., neck) 
compression (collar; n=31) relative to controls (no-collar; n=30) during a competitive football 
season (males; 17.04 ± 0.67 years). Helmet sensors were used to collect daily impact data in excess 
of 20 g (games and practices) and the primary outcome measures, which included changes in white 
matter microstructure, were assessed by diffusion tensor imaging (DTI). Specifically, four DTI 

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measures including fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity (AD), and 
radial diffusivity (RD) were analyzed using a Tract-Based Spatial Statistics (TBSS) approach—a 
voxel based analysis. The final analyses included both an intent to treat (ITT) and per protocol 
evaluation of the collar intervention. The ITT analysis indicated a consistent vascular response by 
the athletes to collar compression, as indicated by internal jugular vein dilation (IJV) superior to 
its application (p< .01). Both groups experienced similar overall g-forces and total head impacts 
during the competitive football season (impacts > 20 g; collar 16983 vs no-collar 17750 (p>.05). 
Significant pre- to post-season reduction in MD, AD, and RD (corrected p<.05) was evidenced by 
extensive WM areas in the no-collar group, while no statistically significant longitudinal change 
was indicated for any of the DTI measures in any WM region in the collar group. Comparing the 
two groups, the no-collar group demonstrated significantly larger pre- to post-season DTI change 
in many WM regions (corrected p<.05). Correlation analysis also showed initial evidence of 
significant correlation between the change in AD in some WM regions and the number of impacts 
and/or the cumulative G-force experienced in the no-collar group (all p<.05). Per protocol, results 
were consistent with presented ITT findings with an expected increase in effect sizes noted in most 
voxel analyses. Our findings, based on four DTI measures known to relate to brain injury, indicate 
a consistent reduction of change in diffusivity parameters noted in the no-collar group at post-
season. This is a literature driven sign of sub-threshold white matter injury due to repetitive head 
impacts during the competitive season. The smaller and statistically non-significant change in 
diffusivity in the collar group evidences a protective effect from the induced jugular outflow 
impedance. Restated, the approach to impede IVJ blood flow appears to have ameliorated the 
detrimental effects that resulted from a season of head impacts. The current study presents the first 
football related prospective longitudinal data and demonstrates a novel, in vivo, approach to 
protect the brain from football related head impacts. These results build on prior research and 
evidence the need for future work to determine if this novel method for brain injury prevention is 
both safe and effective.  Understanding the intracranial mechanism of these potential protective 
effects is critical to further development. 
 
 
G. An in vivo clinical trial was approved by CCHMC IRB and was completed in the 
Cincinnati Children’s Hospital Human Performance Laboratory and Radiology Department (Study 
ID: 2016-0988; PI: Gregory Myer). We aimed to investigate (1) whether repetitive head impact 
exposure during a soccer season induced significant functional changes in the brain network in 
female athletes; and (2) whether a neck collar that applies mild jugular vein compression to 
engorge the cranial reserve volume (to reduce brain slosh during head impact exposure) can 
ameliorate resultant change in brain functional network activation. Neuroimaging data was 
acquired prospectively prior to and immediately following a high school soccer season in female 
athletes. These athletes were assigned to the non-collar group (n=12, age = 15.61±1.00 years) and 
the collar group (n=8, age = 15.30±1.19 years, p = 0.53). Head impact exposures were recorded 
during all practices and games using X2’s X-patch wearable sensor. A standard N-Back task was 
used to engage working memory during functional MRI at both pre- and post-season. On average, 
the athletes in the two groups experienced a similar number of impacts (145±91 vs. 143±23, 
p=0.95). Increased brain activation of working memory was observed from pre-season to post-
season in the non-collar group (p<.05, corrected) but not in the collar group. Compared to the non-
collar group, significantly lower alteration in fMRI brain activation (p<.05, corrected) was found 
in the collar group in the cingulate gyrus and the angular gyrus, both of which are known to be 
associated with memory functions. The current data indicate that repetitive head impact exposure 

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associated with participation in high school soccer is related to the altered functional brain network 
in female athletes. The significantly increased brain activation from pre- to post-season in the non-
collar group suggested that greater effort was required for task completion. The absence of 
alteration of brain activation in the collar group suggests a potential protective effect, supporting 
the growing literature of mild jugular vein compression in brain injury protection in sports.  
 
H. An in vivo clinical trial was approved by CCHMC IRB and was completed in the Cincinnati 
Children’s Hospital Human Performance Laboratory and Radiology Department (Study ID: 2015-
2205; PI: Gregory Myer). We aimed to (1) quantify the longitudinal persistence of altered white 
matter (WM) integrity observed in one high school football season at 8 months post season; and 
(2) evaluate the long term effects of the jugular vein compression collar designed to ameliorate 
alterations in brain network. Prospective diffusion tensor imaging data from 23 male high school 
football athletes (10 non-collar; 13 collar) were acquired at three longitudinal time points: T1 (pre-
season),T2 (post-season) and T3 (following the off-season). The in-season time interval (T1→T2) 
was 4.24±0.52 months and the off-season interval (T2→T3) was 8.48±0.30 months. Tract Based 
Spatial Statistics approach was used to quantify change in the WM anisotropic diffusion properties 
between these time points. DTI remained unchanged across all time points in the collar group. 
Despite similar number/severity of head impact, the non-collar group showed significantly greater 
reduction than the collar group in mean, axial and radial diffusivity between T1→T2 in extensive 
WM regions (corrected p<0.05).  During the presumed recovery off-season period without head 
impact exposure (T2→T3), DTI diffusivity values in the non-collar group increased significantly 
toward baseline, but remained significantly lower (T1>T3; all p<0.05).The non-collar group 
demonstrated WM recovery towards baseline during the off-season relative to post-season DTI 
alterations found following the competitive football season. However the persistence of 
significantly lower diffusion properties may be indicative of incomplete WM recovery. The lack 
of significant DTI change over time in the collar group suggests a protective effect may be afforded 
from the applied jugular compression. 
 
I. An in vivo clinical trial was approved by CCHMC IRB and was completed in the Cincinnati 
Children’s Hospital Human Performance Laboratory and Radiology Department (Study ID: 2015-
2205; PI: Gregory Myer). We sought to (1) identify brain networks in performance of a cognitive 
task, (2) evaluate whether longitudinal changes in performance are associated with alterations in 
brain network connectivity after a season of head contact competitive play, and (3) determine the 
effect of a jugular vein compression device on these relationships. Male high school football 
athletes were assigned to a collar (N=12, age=16.4±1.2) or non-collar group (N=13, 
age=16.2±1.6).  Subject response times (RT) during a visual go/no-go test were recorded before 
and after the season. Neuroimaging data were acquired prospectively pre and post season. 
Functional networks were parcellated from preseason data via independent component analysis 
and intersected with the Harvard-Oxford brain atlas to form regions of interest. For all subjects at 
preseason, RT were positively correlated with connectivity within the salience network (r=0.47, 
p=0.003) but not any other network (p>0.05).  Consequently, we evaluated associations between 
longitudinal changes in RT and connectivity within this network for each group; changes in RT 
were positively correlated with changes in connectivity for the non-collar group (r=0.58, p=0.038) 
but not the collar group (r=0.38, p=0.221).The salience network was associated with RT in a visual 
go/no-go task, consistent with its central role in motivation and a readiness to act. Associations 
between altered RT and network connectivity for only the non-collar group suggests not only that 

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exposure to head impacts may affect critical processing within the salience network, but that the 
collar may afford a protective effect in stabilizing brain network connectivity. 
 
(4)  STUDY DESIGN: 
All testing will be performed in the SPORT Center, Division of Sports Medicine at Cincinnati 
Children’s Hospital.  Ultrasound testing will consist of measurement of dilation and compression 
of the jugular veins following the application of a generic jugular vein compression device.  The 
ultrasound testing will be completed in 20 minutes or less.  
 
(5)  DURATION: 
Each participant will participate in 1 planned study visit that may take up to 20 minutes. Data 
analysis will continue for a 6 month period following the final enrollment.  
 
(6) SELECTION & RECRUITMENT OF PARTICIPANTS 
We aim to recruit approximately 100 healthy volunteers divided equally between the sexes.  The 
normal, healthy participants (age 7-60 years old) will be recruited from local school districts local 
sports clubs and teams, local colleges, adult sport leagues, and professional sports teams, through 
our well established network with area coaches and athletic trainers. To obtain the various age 
groups we will also recruit from that we may recruit from colleagues and staff members. All 
recruited participants will be made aware that participation is voluntary and will not be held against 
them if they decide not to participate.  Questions regarding participation will be answered during 
the presentations or through e-mail or phone. Participants will be contacted via telephone to further 
explain the study, answer any additional questions and to enroll them in the study. The participants 
and parents/guardians (if subject under age of 18) who voluntarily agree to participate will be 
scheduled to complete the pre-participation testing. The participant and parent/guardian (if subject 
under the age of 18) will read and sign the “Consent to Participate in a Research Study” form, 
approved by the Institutional Review Board of Cincinnati Children’s Hospital. If the participant 
and parent/guardian does not read or sign the form, they will not participate in the study.  
Additional Adult volunteers will be recruited via word of mouth or through affiliations with the 
teams/clubs noted above, through personal contacts, or through emails sent via Clinical Studies. 
 
Inclusion criteria 
 Normal healthy volunteer aged 7-60 
 Able to provide written consent 
 Able to tolerate hypercapnia for 1-2 minutes 
 
Exclusion criteria 
 Unable to provide written consent 
 History of neurological deficits, previous cerebral infarction, or severe head 
trauma as indicated through pre-season screening: 
 Medical contraindications to restriction of venous outflow via the internal 
jugular veins (known increased intracerebral pressure, metabolic acidosis or 
alkalosis) 
 Glaucoma (Narrow Angle or Normal Tension) 
 Hydrocephalus 
 Recent penetrating brain trauma (within 6 months) 

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 Known carotid hypersensitivity 
 Known increased intracranial pressure 
 Central vein thrombosis 
 Any known airway obstruction 
 Any known seizure disorder 
 
(7)  PROCESS OF OBTAINING CONSENT 
 
Once a participant is identified as a potential participant, is contacted by a CCHMC/Sports 
Medicine representative and verbally agrees to participate, the process to obtain consent will begin. 
The study coordinator will review the informed consent and the participant will have an 
opportunity to ask any questions regarding the study and/or the study protocol. At that time, the 
participant will be given time to decide whether or not they wish to participate and if so, asked to 
sign the informed consent. Once the signature is obtained, the participant will be given a copy of 
the consent and testing will commence. At no time will the participant be coerced into 
participation. Receiving the informed consent prior to enrollment will allow the participants to 
review the study information prior to participation in the study. This will aid the participant to 
make an informed, unforced decision regarding election to participate in the study. 
 
The participants will be given adequate time to review the study materials and ask questions. If 
they choose to participate, the patient and parent will sign the IRB approved consent/assent forms. 
It will be made clear to the patient and their parents that participation in the study is voluntary.  
Subjects over the age of 18 will complete the Adult Subject Consent Form. 
 
In the event that a parent or guardian will not be present at the scheduled testing appointment, 
consent/assent forms will be provided ahead of time for review. The coordinator will ensure that 
all necessary forms have been signed prior to any data collection. 
 
(8) STUDY PROCEDURES 
 
Ultrasound Testing 
The study coordinator will be responsible for providing the appropriate sized collar based on 
measured neck circumference. At first fitting of the collar a registered vascular technologist will 
utilize ultrasound to ensure that the collar fits correctly and is activated as prescribed. Baseline 
measures with standard collar will be measured and recorded via ultrasound video following the 
methods described below. 
 
Baseline ultra-sound imaging-Standard collar 
Sitting upright, and facing forward, ultra-sound coupling gel is applied to the lateral neck, and the 
right side common carotid artery, and IJV in the transverse plane, are identified to verify normal 
anatomy. Collar positions will be marked on the neck using stickers or other temporary marking 
methods. The collar is then placed into proper position on the study volunteer’s neck.  To further 
evaluate responsiveness to the collar, a 15 s video clip is obtained, recording the collar in its proper 
position, the collar opened away from the neck, and the collar returned to its proper position.  The 
largest transverse dimension at initial collar placement, and the smallest transverse dimension at 
opened collar view and again at proper collar replacement, will be used for IJV metrics.   

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IJV Compression ultra-sound imaging 
With proper placement of IJV compression collar confirmed, pressure is increased in small 
intervals of pressure unilaterally until IJV compression is visually observed. The collar will then 
be rotated radially anterior and posterior to its initial position around the IJV. This process will be 
repeated at .2 increments of pressure until the 1.5 lbs pressure of the standard collar is achieved. 
The ultrasound technologist will record the jugular vein measurements relative to each indicated 
pressure level. 
 
(9)  DATA ANALYSIS/METHODS: 
 
Data Storage.  
The personal demographic data for each participant will be blinded from the researchers, and 
a coded identification number will be used to track all collected data. Data will be stored on 
password-protected computers and only pertinent research personnel will have access. Data 
forms will be stored by coded identification number in a locked cabinet to which only pertinent 
research personnel have access. All data will be collected for research purposes only.  
 
Statistical analyses will performed with SPSS statistical software (SPSS Inc, Chicago IL). Data 
regarding the descriptive information (such as mean and standard deviation) will be calculated 
for demographic, anthropometric and ultrasound variables of interest. Sex and age specific 
analysis will be compared between the test conditions (baseline vs. X pressure) using a paired 
student T-test.   
 
(10) FACILITIES AND PERFORMANCE SITES: 
All ultrasound testing will be performed in the SPORT Center in the Division of Sports 
Medicine.  
 
(11) POTENTIAL BENEFITS: 
Participants of this study will not receive any direct or immediate benefits by completing this 
study. However, they will be contributing to research involving the potential for major 
contributions to future TBI/concussion prevention strategies. 
 
(12) POTENTIAL RISKS, DISCOMFORTS, INCONVENIENCES AND PRECAUTIONS: 
The Device partially circumnavigates and compresses the neck in the same way that a 
compression garment (non-medical apparel) behaves, and very similar to the compression 
exerted by a necktie (although this device is open over the trachea and can be pulled off if 
inadvertently gripped). These garments have been shown to gently facilitate natural response 
mechanisms in several small neck muscles and tendons (the Omohyoids), which are 
universally present in mammals and birds. 
 
The physiologies imparted by these Omohyoids (and further facilitated by these garments) 
merely approximate natural physiologies, which occur when individuals lie in the prone, or 
supine position, and are also comparable to the simple act of yawning (which has been shown 
to collapse the jugulars). The Device will intentionally deliver an exacting, but gentle 
compression to the Omohyoid muscles in the neck allowing these muscles to optimize blood 
outflow of the neck vasculature. In the upright position (without the collar), the resultant 

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vascular blood column siphons volume out of the neck, rapidly, creating a negative pressure 
on the cranium and resulting in a slight “under filling” and “sloshability” inside the skull. 
The Omohyoid muscle raises the volume of the intracranial space by design. The Device does 
not contain any inherently rigid structures in its design. Similarly, neckties circumnavigate the 
neck, and safely raise intracranial pressure and volume comparable to the Device. The Device 
is manufactured of a soft rubber similar material and should be barely noticeable to the wearer. 
Careful MRI studies have confirmed an increase in blood volume in the brain but have also 
shown that there is no significant change in brain blood flow pattern with wearing a “tight 
necktie” (Rafferty, Quinn et al. 2010).  
 
Although the venous jugular flow beneath the pressure cuff may be temporarily halted or 
slowed, the venous outflow from the cranium is never completely stopped, particularly from 
the anastomosis between the spinal vein and the basilar plexus and occipital sinuses which are 
incompressible.”(Gregg and Shipley 1944) Jugular compression has few known physiological 
effects besides the intended increase in cerebral blood volume and pressure. Only one 
innocuous physiology has ever been shown to alter with jugular compression. “Previous 
studies have shown that the decline in urinary sodium excretion which occurs normally in the 
sitting position, as compared with recumbency, can be partially but not completely prevented 
by compression of the neck (Lewis, Buie et al. 1950, Torres and Ellington 1970). This decline 
is urinary sodium excretion is minimal. There was no correlation between EEG changes and 
changes in systolic blood pressure occurring during jugular or carotid compression(Torres and 
Ellington 1970). Further, studies on complete resection of the IJV note that, “the clinical 
observation that bilateral resection of the IJV is usually well tolerated suggests the presence of 
alternative, non-jugular pathways.”(Gius and Grier 1950)  
 
Effect of Body Position and Exercise on ICP: “At rest, compared with the reference 30-degree 
head-up position, the supine position increased intracranial pressure (ICP) by 6.21 mm Hg 
(35% with P<.01).”(Brimioulle, Moraine et al. 1997) Restated, just lying down increases ICP 
more than the Device (6.21mm Hg = 35% rise versus this device at only 25%). Valsalva and 
raising ICP: We define Valsalva, where a person tries to exhale forcibly with a closed glottis 
(windpipe), so that no air goes out through the mouth or nose. “When the Valsalva maneuver 
was performed during resistance exercise, the ICP rose to 31 mmHg (a rise of 138%). No 
complications were associated with participating in this investigation.”(Haykowsky, Eves et 
al. 2003) In other words, the Device facilitates the intended actions of the omohyoid with less 
pressure than the act of lying down or performing the Valsalva (holding one’s breath and 
bearing down, which would be expected to occur regularly on a playing field). 
 
Instead of letting three to five milliliters of blood rapidly flow out of one’s brain upon standing, 
the Device will serve to retain that fluid inside the skull where it is believed to cushion the 
brain from external energy impacts and concussions. In rats, this simple action prevented 83% 
of TBI indicators during two 900 G impact studies at the West Virginia University.(Smith, 
Bailes et al. 2012, Turner, Naser et al. 2012)Considering the above mentioned findings on 
jugular compression, this device can be considered not to meet the definition of a “significant 
risk device,” as that term is defined in 21 C.F.R. § 812.3(m). As noted above the collar has 
been tested extensively in laboratory and field settings without reported adverse events. 
 

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Data Storage. There is also a minimal risk that the data collected for each participant may be 
viewed by individuals outside the research team. The risk that confidential data may be viewed 
is relevant for both the written forms and electronic databases. Precautions, such as password-
protected computers, locked cabinets and coded identification numbers, are in place to 
minimize this risk. 
 
Adverse Events. As described in the consent, if a participant believes they have sustained an 
injury as a result of the study then they are instructed to contact the principal investigator or 
director of social services who in turn will then contact CCHMC IRB and necessary funding 
institutions, as aforementioned. If a participant sustains an injury during testing they will be 
referred to the most appropriate medical facility or seek medical attention by the 
physician/medical specialist of their choice. 
 
(13) RISK/BENEFIT ANALYSIS: 
Participants will be approached for participation via the appropriate method. The purpose and 
the study protocol will be fully explained in conversation and with the informed consent 
process.  
 
On the day of the study, the investigators will confirm that the volunteer participant has no 
health impairment as outlined in the exclusion criteria. Time will be taken to repeat the aims 
of the study, test protocol, and to answer any remaining questions posed by the participant. 
The methods described in this protocol have been used extensively in previous testing in the 
laboratory. During previous testing, there have been no reported injuries, adverse events or 
complications. Additionally, the investigators have considered potential risk for injury and 
have taken additional steps, described in the protocol, to minimize these risks.  
 
Subject participation will be halted should an adverse event while wearing the collar, such as 
syncope, occur. Any adverse events will be immediately reported. The safety officer will 
evaluate all adverse events and will determine if early stopping of the study due to safety 
concerns is warranted. Given the study design and sample, we do not deem futility or efficacy 
stopping rules are warranted. 
 
(14) DATA SAFETY & MONITORING: 
 
Dr. Kate Berz will serve as a study monitor for this project for any incidental findings, while 
the PI and study coordinators will be responsible for monitoring data quality and adverse 
events. The monitor will review adverse events and unanticipated events at the time they occur 
and will report his assessment of the event(s) to the PI. 
 
This research study involves only minimal risk for participants (see Risk/Benefit Analysis 
section (15)). Further assurances regarding participant safety and protection of private and 
confidential participant information have been outlined in the Potential Risks, Discomforts, 
Inconveniences and Precautions section (14), the Privacy section (18) and the Confidentiality 
section (19). If during the, preliminary analyses the research team identifies strong evidence 
of harm from the Q-collar device the study will be stopped immediately. 
 

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(15) PRIVACY AND CONFIDENTIALITY: 
The participant has the right to privacy. The investigators will protect participant privacy to 
the extent allowed by law. All facts about this study that can describe a participant’s name will 
be kept private. Results of the study will be summarized regarding age, etc. but the 
investigators will take every precaution necessary to keep names private.  
 
To maintain the privacy information of study participants, only pertinent research personnel 
will have access to participant information. Research personnel are employees of CCHMC and 
have been trained in human participant’s research and HIPAA compliance. To further insure 
privacy, all data will be analyzed and tracked using a coded identification number that does 
not use identifiable personal information. Personal information and identifiers will be securely 
recorded and filed by the administrative assistant. The data will be encrypted with a password 
and stored on a personal computer and backed up on a network drive. The participant 
identification code will be used on all data questionnaires. 
 
The results of this study will be kept confidential. No participant identification will be made 
public record in any form unless the participant gives his or her expressed written permission 
of release of participant’s name, photograph or likeness captured on video. The investigators 
will be available for any questions that may arise. 
 
To further insure confidentiality, only pertinent research personnel will have access to 
participant information. Research personnel are employees of CCHMC and have been trained 
in human subjects research and HIPAA compliance.  
 
(16) COST OF PARTICIPATION: 
Participants will endure no costs other than time and effort in participating in this study. 
Insurance will not be billed for any of the tests associated with this study. 
 
(17) PAYMENT FOR PARTICIPATION: 
Participants will be compensated for their time and effort in participating in this study. They will 
receive a $50 Clincard Mastercard® gift card for completing the testing.  Registration in the 
Clincard payment system requires a social security number, which will be acquired via a complete 
W-9 form for each participant. Participants will be compensated even if they are not able to 
complete the entire MRI session. 

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