Novel Protection Against Potential Brain Injury During Competitive Non-helmeted Sport in Females
Phase: NA
Conditions: Concussion, Mild, Concussion, Brain
Sponsor: Children's Hospital Medical Center, Cincinnati

STUDY TITLE: Novel protection against potential brain injury during competitive non-
helmeted sport in females. 
 
IRB#: 2016-0988 
NCT#: NCT03014492 
Approval Date: 03/01/2016 
 
 
 

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CINCINNATI CHILDREN’S HOSPITAL MEDICAL CENTER 
 
STUDY TITLE: Novel protection against potential brain injury during competitive non-
helmeted sport in females. 
 
INVESTIGATOR INFORMATION: 
Gregory D. Myer, PhD 
 
(513) 636-0249 
 
Principal Investigator Name  
Telephone Number 
 
 
 
 
(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 incurred 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.  
 
This study will investigate the effectiveness of this device in high school athletes playing a 
non-helmeted sport such as soccer. Athletes participating in this study will be randomly 
assigned to one of two groups: 1) Device wearing during the season or 2) Non-device 
wearing during the season. This study will focus on the use and effectiveness of the device 
solely in females, as male football and hockey players have previously been investigated. All 
participants will be outfitted with an adhesive patch-like accelerometer (which will be placed 
behind the ear (Xpatch–X2 Biosystems http://www.x2biosystems.com/x2_x_patch/) which 
will measure the magnitude of every impact to the head sustained by the athlete. 
Effectiveness of the device will be determined via differences in longitudinal brain imaging 
and functional testing following competitive soccer participation. A subset of athletes who 
report a diagnosed concussion will also receive additional brain neuroanatomical and 
neurophysiological testing within a week following the diagnosed concussive event. At each 
of these time points participants will also undergo various neurocognitive assessments 
outlined below. 
 
(2) PURPOSE OF STUDY: 
The purpose of the study is to monitor longitudinal changes in brain structure and function 
between the preseason and postseason, in a population of soccer playing athletes wearing the 
Device and compared to a similar population not wearing the device. Secondly, the purpose 

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is to determine the protection of the device relative to amount and magnitude of sustained 
head impacts.  
 
(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). 
 
Anatomically and physiologically, there remain many differences in the male/female 
genders.  Interestingly, there has also been disparate prognosis and incidence of TBI in 
female athletes exposed to concussive impacts.  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 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. 
Young female athletes appear to suffer many of the highest incidences of TBI in the sports 
arena.  Specifically in the sport of soccer, girls have a concussion incidence rate of 0.36 per 
1000 athlete exposures (AE), the highest for all girls’ sports.(Gessel, Fields et al. 2007)  
Others have contemplated a lack of neck muscle strength or endurance that seemingly just 
doesn’t justify the differentiation noted.  On the other hand, cranial vault differences are quite 
real and starkly different.  Specifically, females and especially younger females are known to 
have a greater compensatory reserve volume that trends towards males as they age.  This 
metric does seem to follow that of known TBI predisposition.  Further, daily or weekly 
changes in hormonal metrics could alter the day to day risk of suffering a TBI and could 
explain the erratic data accumulated to date if not controlled for in a scientific manner. 
 
In this light, we explore the effects of estrogen and progesterone on the risk for suffering TBI 
and the need to study these effects when performing prospective studies of young female 
athletes.  Fluctuations in endocrine status may have a global impact on cerebral circulation 
and can also cause regional alterations in the blood flow of specific brain regions(Szelke, 
Mersich et al. 2008).    
During the early follicular phase (day 1 to 5 of cycle), women exhibit greater basal CBF than 
men, but similar vasodilatory responses to hypoxia and hypercapnia (Peltonen, Harrell et al. 
2015). There remain differences in cerebral vascular reactivity between the sexes and these 
should be highlighted due to the obvious alterations in CO2 in sport (Kastrup, Thomas et al. 
1997, Kastrup, Dichgans et al. 1998)Aging is also known to contribute to CO2 reactivity (in 
women only) and thus one would expect greater changes in the younger athlete verse the 
aged (Kastrup, Dichgans et al. 1998).  Further, “results demonstrate that the CO2 sensitivity 
of the hemispheric vessels is sex hormone dependent. Estrogen and progestin treatment have 
opposite effects on this cerebral circulatory parameter(Szelke, Mersich et al. 2008).”   

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Evidence indicates that sex steroid hormones influence the functionally unique capillary bed 
of the brain and blood-brain barrier permeability(Krause, Duckles et al. 2006).  Estrogen 
treatment of young, ovariectomized rats significantly reduces dye extravasation into both the 
olfactory bulb and hippocampus, indicating a general tightening of the barrier (11). We have 
found in rat cerebral blood vessels that endotoxin-mediated induction of COX-2 and iNOS is 
increased when animals are treated chronically with progesterone or medroxyprogesterone. 
Induction of inflammatory mediators by endotoxin was dramatically enhanced in female 
cerebral vessels on the day of estrus when the plasma level of 17-estradiol is low and 
progesterone is high.  During pregnancy and the postpartum period in rats, aquaporin 4, a 
water channel associated with brain edema, is increased around intracerebral blood 
vessels(Krause, Duckles et al. 2006).  
There is a vast amount of evidence for hormone-dependent modification of function and 
behavior during the menstrual cycle, but little is known about associated structural alterations 
of the brain(Kastrup, Dichgans et al. 1998, Krause, Duckles et al. 2006, Szelke, Mersich et al. 2008, Hagemann, Ugur et al. 2011, 
Peltonen, Harrell et al. 2015)  During the menstrual cycle estradiol levels show a marked peak at 
ovulation and progesterone levels rise afterwards with a broader peak towards the next 
menses.  On the other hand the brain volume change, and even more so the associated loss in 
CSF-volume between t1 and t3 which by itself was not significant, correlates well with 
changes in progesterone levels.  We demonstrate for the first time that brain morphology 
varies during the menstrual cycle, with a (grey matter) volume peak at time of ovulation 
which can be estimated to be ,13,5 ml for a ‘‘standard’’ brain (Hagemann, Ugur et al. 2011).  
We would expect alterations in TBI susceptibility based on the altering levels of estrogen and 
progesterone in menstruating females (due to brain volume changes presumably affected by 
alterations in cerebral blood volume) whereas this is obviously not the case in males.  As a 
theory of TBI pathophysiology gaining ground is the alteration in Blood Brain Barrier and 
estrogen/progesterone does contribute to this physiology as well, we also anticipate 
variations in injury and prognosis of the female athletes based on the timing of their 
menstrual cycles.   
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-

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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. 
 
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.  
 
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 

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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. 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.  
 
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 

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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 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. 
 
(4) STUDY DESIGN: 
The current project will be designed following a prospective longitudinal study design. All 
MRI scanning will be performed on a 3 Tesla Philips Achieva MRI scanner located in 
Imaging Research Center (IRC) in the Cincinnati Children’s Hospital Research Foundation 
(CCHRF). Sedation will not be used for any of the test visits. The entire MRI series, 
including anatomical imaging, DTI, resting state fMRI, SWI, HARDI, ASL and BOLD will 
be completed in 60 minutes or less (see Table 1 for detailed specifications). Peripheral pulse 
oximetry and respiration waveforms will be collected for signal correction in functional MRI 
in order to improve data analysis for resting state fmri to minimize the potential confounding 

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effect from the physiological changes.  All functional and neurocognitive testing will be 
performed at the Cincinnati Children’s Hospital Human Performance Laboratory.  
 
Table 1. Image sequence, mode and analysis. Imaging will be completed in 60 minutes or 
less.  
 
Sequence
Resolution
Mode
Analysis
Time 
(min) 
3D T1
1x1x1 mm
Anatomy
Visual /Volumetrics/registration
5
DTI
2x2x2 mm
WM microstructure
Visual/ROI/TBSS/structural connectivity
12
rs-fMRI
3x3x4 mm
Network Connectivity
Functional connectivity
10
N-back 
fMRI 
3x3x4 mm
BOLD activation
Quantitative
6
HARDI
2x2x2 mm
WM microstructure
Tractography, structural connectivity
12
SWI
SWI
Hemorrhagic Injury
Visual examination for incidental finding
6
Total Time
~57 min
 
(5) DURATION: 
The study recruitment and intervention will occur during one season. Each participant will 
participate in at least 2 planned study visits that may take up to 3 hours. Data analysis will 
continue for a 2 year period following the final enrollment.  
 
(6) SELECTION & RECRUITMENT OF PARTICIPANTS: 
We will recruit up to 150 study participants. The participants (age 14-19 years old) will be 
recruited from a local school district and local sports clubs and teams. Participants will be 
recruited using a top-down approach. We have gained the consent and the cooperation of the 
school district administrations. Presentations and letters from the research team will be given 
to each participating school to detail the participation requirements and study risks.. 
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 who voluntarily agree to participate will be scheduled to complete the pre-
participation testing. The participant and parent/guardian 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. Once the potential study participants/school 
teams are identified, they will be allocated to one of two groups: 1) Device wearing during 
the season or 2) Non-device wearing during the season. This research does not mandate that 
the participant maintains participation in their sport. The desire to participate in the sporting 
event is an independent, personal decision separate from the decision to enter into this study. 
If any athlete choses to stop participation in the sporting activity then they will also be 
withdrawn from the study, due to no longer meeting inclusion criteria.  
 
Inclusionary criteria include: 
 Female 

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 Normal healthy volunteer  
 Able to provide written consent 
 Must be 14 years or older and a participant on a high school soccer team 
 
Exclusionary criteria include:  
 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) 
 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. 
 
Because we will be testing teens, we will be using the Parent Consent Form to obtain both 
the participant assent and the parent consent. The participants and their parents 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 forms. It will be made clear to the 
patient and their parents that participation in the study is voluntary.  
 
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: 
 
Location I – Brain Imaging-Performed at CCHMC Imagining Research Center 
 

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MR imaging data Acquisition 
Magnetic Resonance Imaging (MRI), including sequences outlined in Table 1 are all based 
on the concept of using magnetic fields and radio waves to make chemical, anatomical and 
physiological assessments with in the living tissue. This technology has been utilized for 
diagnostic and research purposes since the early 1980s.  
 
This testing will consist of a minimum of 2 MRI sessions (preseason, and post season) and 
additional scans following any clinically diagnosed concussions, all inside a 3T scanner at 
the CCHMC Imaging Research Center. During the acquisition of MR images, the study 
participants will lie on the scanner table. For most portions of MR acquisition, the study 
participants will only be instructed to lie still. For other parts of the acquisition, study 
participants will be asked to answer questions that will assess their cognitive ability and 
working memory. Participants will be allowed to communicate with the MR operator via an 
always-on, two-way intercom at any time. In addition, the participants have a hand-held air 
ball to squeeze in the event that they elect to be removed from the magnet immediately. The 
study participants have control over their presence in the magnet, which in turn tends to 
minimize feelings of claustrophobia. As magnetic resonance imaging employs the use of 
strong magnets, patients will receive a standard preoperative screening questionnaire 
regarding the potential for ferromagnetic objects within their bodies to ensure their safety 
during the study. Participants will be screened for MRI specific contraindications such as: 
• 
Braces or permanent metal dental work 
• 
Insulin pump 
• 
Cardiac pacemaker 
• 
Cochlear implants 
• 
Hearing aids 
• 
Aneurysm clips 
• 
Orthopedic pins, wires, screws, or plates 
• 
Any other exclusionary criteria as documented on the MRI safety screening poster 
included with recruitment materials 
 
Those participants with any aforementioned contraindication may be excluded from the 
imaging portion of the study but will still be eligible to participate in the rest of the study 
procedures. 
 
Location 2 -Physical and Cognitive Testing Performed at CCHMC Human Performance 
Laboratory 
 
Station I: Anthropometric Measurements.  
Anthropometric measures will be recorded at Station IV. Height, weight, and body 
composition (bioelectrical impedance) will be recorded and body mass index (BMI) 
calculated. 
Height: A measure of height will be recorded with a digital stadiometer (accurate to 0.25 
cm).  
Weight: A measure to the nearest 0.5 kg will be taken on a calibrated physician scale with 
the participants’ shoes off. 

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Neck Measurement: We will measure the circumference of participant’s neck with a 
measuring tape. 
 
  
Station II – Occulomotor Assessment 
 
 
All participants will sit in front of a desktop monitor. During this process, the participant 
will look at several points in order to calibrate the desk-top eye tracker (Tobii X2 60). All 
participants will participate in three oculomotor performance tests: (1) a reflexive saccade 
test, (2) a self-paced saccade test, and (3) a smooth-pursuit tracking test. All tests will be 
presented on a PC monitor approximately 1.5 m away from participant, and stimuli will be 
automated using customized MATLAB (Mathworks, Natick, MA) routines.  
 
 
Reflexive Saccades. Reflexive saccades will be tested as participants track discrete target 
motion that will jump randomly by 14, 16, 18, 20, 22, or 24˚ on the screen in a horizontal and 
vertical direction, at intervals varying pseudo randomly between 1.0 and 2.0 s. The current 
fixation target will be extinguished at the same time as the next peripheral target appears. The 
test sequence will take 30 s/trial (2 trials) and all participants will be instructed to follow the 
targets as quickly and accurately as possible. Dependent measures for reflexive saccades will 
include: (1) saccade latency (ms), (2) saccade velocity (˚/s), (3) mean absolute position error 
of the final eye position, (4) gain of the primary saccade, and (4) gain of the final eye 
position.  
 
 
Self-paced saccades. Self-paced saccades will be assessed as the participant glances back 
and forth as quickly and accurately as possible between two constantly visual targets at ± 15˚ 
horizontally from one another. This test will take 30 s per trial and the participant will 
perform 4 trials. The dependent measures will be: (1) the number of refixations within 30 s, 
and (2) the mean intersaccadic interval (ms).  
Self-paced saccades combined with smooth pursuit tracking. A series of self-paced saccade 
tasks will be presented in which either, (1) a stationary and moving target (horizontal or 
vertical) is presented, (2) two horizontally moving target are presented, or (3) two vertically 
moving targets are presented. The participant will be instructed to glance back and forth 
between the targets as quickly and accurately as possible. Each test will take 30 s per trial 
and the participant will perform a total of 22 trials over ~ 11 min. The dependent measures 
will be: (1) the number of refixations within 30 s, and (2) the mean intersaccadic interval 
(ms), (3) average eye peak velocity (˚/s) after removal of all saccades from the tracking 
performance, and (4) the tracking lag (ms). Total oculomotor testing time will take 
approximately 10 minutes, and all eye data will be recorded using Tobii Studio software and 
will be sampled at 60 Hz. 
 
 
ADHD rating scale:  The ADHD rating scale queries parents how often their child 
exhibits each of the DSM-V ADHD symptoms on a 4-point Likert scale. 
 

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Menstruation Questionnaire – In order to determine the status of menstrual cycle, each 
participant will complete a questionnaire monthly, while participating in the study.  Answers 
from this questionnaire will allow study staff to determine the approximate status of their 
cycle. This questionnaire will be administered using the electronic data capture REDCap.  
REDCap is a secure, web-based application for building and managing online surveys and 
databases.  It is a resource of the Center for Clinical and Translational Science and Training 
(CCTST) provided to researchers.  Subjects will be emailed the link to complete the 
questionnaire each month during participation in the study.  All data will be de-identified via 
a study ID, assigned to each participant when enrolled in the study.  Participants will also 
complete a Pre-Season Menstruation Questionnaire at the first study visit. 
 
Injury Surveillance 
Device and Compliance Acceptance: The study coordinator will be responsible for providing 
the appropriate intervention (device or no-device) to each team based on their assignment 
prior to the season onset. 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. 
Following the initial fitting, each athlete will receive adequate instruction on how to properly 
use the device on a daily basis. Throughout the season, the coordinator will make routine 
visits to each team to monitor the proper usage and fitting of the device, tracking the use of 
the device by each athlete individually.  At the end of practice/game the device will be 
collected by the athletic trainer and/or stored in the athlete’s locked locker.  The device is 
NOT to go home with the athlete. 
  
New Concussion Surveillance and Follow-up: Each participant will be provided with an X 
Patch accelerometer (X2 Biosystems; Seattle, Washington) The X patch adheres to the head, 
just behind the ear using an adhesive patch, as seen in the image below.  .  
 
X2 is a small and durable device that is attached to the back of the neck behind the ear to 
track impacts, and it stores data for uploading to a PC. This X2 accelerometer accurately 
measures the severity of impacts by converting data such as high impact collision into usable 
data outputs. X2 data will be used in final analysis to normalize the exposures to potential 
concussive events. All impacts of greater than 10 g-force will be recorded and utilized in the 
post-season analyses. No one besides those approved by this IRB protocol will have access to 
any data. If available, video of games and practices will be used to validate and confirm head 
impacts recorded by accelerometers.  

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Figure 3. illustrates the steps that will be initiated when 
a concussive event is observed.
  
The study participants will also 
be monitored on a weekly basis 
for athletic exposures, and new 
injuries for a single season. 
Injury 
surveillance 
and 
concussion incidence will be 
monitored by the AT (K. 
Barber Foss) who will work 
directly with team athletes to 
visit each school and each team 
weekly following the initial 
screening. 
We 
will 
be 
monitoring injuries throughout 
the competitive sports season 
and 
collecting 
information 
about injuries from the school 
athletic trainer. Concussion will 
be 
reported 
according 
to 
criteria outlined in recent multi-
investigator 
consensus 
documents (McCrory, 2013). The incidence of concussion will be calculated in this study 
using cases identified through two primary mechanisms: 1) Monitoring of concussion 
injuries and time missed from planned physical activity by the AT for each team, and 2) 
weekly inquiries to each coach by the Study Coordinator as to whether any participants are 
missing time from activity due to concussion. This dual query approach enables the Study 
Coordinator to cross check the injury and exposure data collected to improve the accuracy of 
the data. The data secured from the coach regarding each athlete’s participation in individual 
practices and games combined with accelerometer exposure to impacts allows the research 
team to capture robust individual athlete exposures rather than just combined team 
exposures. 
 
The athletic trainer will evaluate any athlete for whom a concussive event has been observed 
(within 24 hours). If criteria for concussive sequelae are not met, the athlete is cleared for 
return to play. In the event of a positive concussion evaluation by the AT, an MD will 
perform a second evaluation. Should the MD concur with the AT on a positive evaluation, a 
diagnosis of isolated concussion is made and the athlete is removed from play and participant 
is referred for to a post-concussion evaluation. The diagnosing physician will be blinded to 
the experimental treatment of the study participants. 
 
Post-concussion and post season testing consists of the same battery of tests as performed for 
pre-season testing, which allows for direct comparison between typical and concussed data. 
In addition, concussed athletes will complete the Post-Concussion Symptom Inventory 
(PCSI) questionnaire at the beginning of the testing session.  Diagnosis and treatment of a 
concussion is not effected in anyway by participation in the study.  In addition, no post-

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concussion testing completed as part of the study, will be used in making any clinical 
decisions for return to play. 
 
(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. 
 
 
Data Analysis.  
Data processing and analysis will be performed using a series of existing software including 
FSL (FMRIB’s Diffusion Toolbox in FSL Software, Oxford, UK), AFNI (Cox, 1996) , SPM 
(Statistical Parametric Mapping analysis package, Wellcome Department of Cognitive 
Neurology, London, UK), DTIStudio (John Hopkins University, Baltimore, MD; Jiang et al., 
2006), as well as additional customized software written in Matlab or IDL.  
 
DTI data will first be subjected to preprocessing to correct for Eddy current and head motion 
artifact, followed by calculation of the three diffusion eigenvectors and eigenvalues. DTI 
measures, including fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity 
(AD), and radial diffusivity (RD) will be calculated. The regions of interest will be manually 
determined in major white matter areas such as corpus callosum, internal capsule, and 
external capsule. After being normalized to a common template, voxel based group analysis 
can be performed to explore brain regions that present significant group difference or 
longitudinal changes. Fiber tracking can be performed to generate white matter tracts in 
different areas in the brain, e.g., cortico-spinal tract, different segments in corpus callosum, 
optic radiation, cingulum superior longitudinal fasciculus, and others.  
 
Functional fMRI (resting state fMRI) will also be subjected to routine image pre-processing 
pipeline. Functional connectivity analysis will be performed, using the CONN toolbox, 
http://www.nitrc.org/projects/conn/) between all brain regions that are involved in the proper 
functioning of default mode network, sensory motor network, visual network, and a series of 
other networks that are known to be strongly functionally connected during resting state. 
SWI, HARDI and ASL BOLD will undergo standard image post-processing. 
 
Statistical considerations. The data analysis will begin with a review of descriptive statistics 
for all major variables and all major subgroupings of variables in the data set. For the 
inferential methods, we will use a number of different generalized linear modeling 
techniques, including linear regression models. All analyses will be conducted using SAS® 
version 9.3 (SAS Inst, Cary, NC), or Mplus (Muthén, 2007). Initial analyses will be 
undertaken to inspect data for errors, inconsistencies, and incomplete information. This will 
include examining the data with simple frequency tables and dot plots for univariate data and 
scatter plots and multi-way dot plots for bivariate and multivariate data. Data anomalies that 
cannot be resolved by the Biostatistical/data management team will be sent as queries via 

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email to the project investigator for clarification and/or correction. During the verification 
process, outlying values will be corrected if necessary. Incomplete information will be 
corrected and the project investigator will receive updates. To summarize bivariate 
relationships among predictors and between predictors and outcomes, Chi-square of Fisher’s 
exact test or Spearman’s rank correlation coefficient, will be used, as appropriate. For 
reporting inferential statistics, such as differences in rates or means, 95 percent confidence 
intervals will be used extensively to quantify degree of clinical efficacy. Unless otherwise 
stated, statistical tests are considered two-sided and a .05 significance level is used. All 
models will be adjusted for potential independent predictor variables but will be limited to 
the number of predictors we can fit in a regression model while maintaining a valid and 
reliable model. Candidate predictors include amount of playing time, amount of practice 
time, previous mTBI, weight, age and height. Collinearity will be examined. Linearity 
assumptions will be checked and transformations examined. In those cases, a log 
transformation, polynomial terms, or restricted cubic splines will likely be used to relax the 
assumption of linearity in the regression models. We will remove the nonlinear terms or 
transformation only if the nonlinear test is non-significant with a p≥.10. Additionally, overly-
influential observations and distributional assumptions will be checked. Models will be 
interpreted graphically, predicted values will be examined, and appropriate significance tests 
will be utilized. 
 
Statistical analyses. - Statistical analysis of outcomes measures will be done using SAS®, version 
9.3 (SAS Institute, Cary, NC) and SPSS statistical software (SPSS Inc, Chicago IL). 
Comparisons between the testing conditions (collar vs. no collar) will be made using Analysis of 
Covariance, in order to control for time (pre vs post season) and condition (collar versus no collar).  
We will also conduct correlation analysis to test the association between imaging biomarkers (as 
described above) with the results obtained from the impact surveillance. The collision indices, 
including total number of collisions, number of collisions from front, back, left, right, top, bottom, G 
force, and timing of each collision will all be recorded and tested in the analysis. Secondary analysis 
to compare the intervention with no intervention and calculate the rates would involve a 
Poisson model, using an offset to account for the playing time and exposure to concussive 
impact for each of the study participants. We will calculate the rate and the associated 95% 
confidence interval. SAS®, PROC GENMOD will be used for analysis, which allows us to 
account for the fixed and random effects, use the appropriate link function, and the offset for 
amount of playing time exposure. 
 
Simple Reaction Time 
A repeated measures mixed-model design will be employed. A total of up to three groups 
(Device vs. no device vs concussion) will be examined using a 3 x 2 (group by time point; 
pre-season vs. post-season) ANOVA. 
 
Oculomotor Measures 
Oculomotor control performance will also be compared using a 3 × 2 mixed-model ANOVA for each 
of the dependent variables. For smooth pursuit tracking performance, mean eye peak velocity and 
tracking lag will be submitted to separate 3 (group) × 2 (session) × 2 (random vs. sinusoidal task 
condition) mixed-model ANOVA. 
 
(10) FACILITIES AND PERFORMANCE SITES: 

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All MRI scanning will be performed on a 3 Tesla Philips Achieva MRI scanner located in 
Imaging Research Center (IRC) in the Cincinnati Children’s Hospital Research Foundation 
(CCHRF). Sedation will not be used for any of the test visits. The entire MRI series, 
including anatomical imaging, 3d T1, DTI, rs-fMRI, SWI, and HARDI will be completed in 
60 minutes or less (see Table 1. below for detailed specifications).  
 
(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 
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 

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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). 
 
MR Imaging of the Brain: The risk the magnetic fields and the strengths, and radio waves is 
vanishingly small. Some patients can experience anxiety from the confined space of the 
magnet’s bore. Therefore people with known claustrophobic tendencies may be excluded 
from the study. Another minor concern when using magnetic resonance technology is the 
noise the magnet makes when collecting data. Noise abatement measures are used; 
headphones and music with a selection of music options. Ferrous implants and or piercings 
can be affected in the magnetic field. Therefore participants will be advised to remove these 
and or scanned with a metal detector to screen for such objects.  
 
Our colleague’s previous experience with MRI experiments (who will be present and has a 
decade of experience with this technology) has provided confidence that there should be no 
psychological, physical, legal, or social risks involved with MRI experiments in general, 
though participants may be anxious about the scan, possibly causing them slight stress. The 
MRI scanning will be performed using the 3 T Siemens Trio MRI scanner. MRI does not 
involve ionizing radiation and scans up to 8 T are considered as non-significant risk. The 
risks common to all MRI scans can be described as: (1) ferromagnetic objects introduced into 
the magnetic field, (2) confinement in the scanner bore, (3) radio-frequency (RF) heat 
deposition in tissue which is monitored by the system to conform with FDA guidelines, and 
(4) acoustic noise. These risks are addressed below: Participants are allowed to communicate 
with the MR operator via an always-on, two-way intercom at any time. In addition, the 

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participants have a hand-held air ball to squeeze in the event that they elect to be removed 
from the magnet immediately. Thus, the participants have control over their presence in the 
magnet, which in turn tends to minimize feelings of claustrophobia.  
 
The MR imaging will be initially reviewed by a licensed radiologist just as it would be if it 
were being used as part of routine medical care. There is a possibility that while reviewing 
MR images we may see an abnormality that we did not expect to see in this study. In this 
event, we will notify the participant’s legal representative (or participant is 18 years or older) 
if we see such an incidental finding. Depending on the type of incidental finding, we may 
contact the participant by mail or by phone. A member of the research team will discuss the 
incidental finding with the legal representative (or participant if over the age of 18 years). If 
the participant chooses, we will give information about this incidental finding to their 
primary doctor or we will refer them to an appropriate doctor for further evaluation. The 
costs for any care that will be needed to diagnose or treat an incidental finding would not be 
paid for by this research study. 
 
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. During the course of the investigation, injuries consistent with the sports 
being monitored are expected to occur (E.g. concussion, musculoskeletal injury, bone 
fractures). Care of all injuries will follow standard of care as directed by the team’s athletic 
trainer and/or the participants treating physician. CCHMC will not be responsible for the 
medical treatment of any injuries that are not directly related to wear of the Q-collar device. 
In the case of an adverse event that is determined to be directly related to the wear of the Q-
collar during competitive play, the principal investigator will report such event to Cincinnati 
Children’s Hospital Medical Center IRB as any future funding organizations in a manner 
consistent with the requirements of each organization. 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. 

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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: 
The Safety Officer (Dr. Paul Gubanich, MD) who has extensive experience in the 
management of concussion at the professional, collegiate, high school and middle school 
level will act in an advisory capacity to the Principal Investigator (PI) to monitor patient 
safety and progress for the clinical trial, “Concussion Prevention Device”. Dr. Gubanich will 
be the contact person for severe adverse event reporting. 
 
The Safety Officer’s responsibilities are to: 
• 
review the research protocol, informed consent documents and plans for data safety 
and monitoring; 
• 
evaluate the progress of the trial, including periodic assessments of data quality and 
timeliness, participant recruitment, accrual and retention, participant risk versus 
benefit, performance of the trial site, and other factors that can affect study outcome; 
• 
consider factors external to the study when relevant information becomes available, 
such as scientific or therapeutic developments that may have an impact on the safety 
of the participants or the ethics of the trial; 
• 
review study performance, make recommendations and assist in the resolution of 
problems reported by the PI; 
• 
protect the safety of the study participants; 
• 
report to the PI on the safety and progress of the trial;  
• 
make recommendations to the PI concerning continuation, termination or other 
modifications of the trial based on the observed beneficial or adverse effects of the 
treatment under study; 
• 
ensure the confidentiality of the trial data and the results of monitoring; and, assist the 
PI by commenting on any problems with study conduct, enrollment, sample size 
and/or data collection. 
 
The Safety Officer and PI will hold meetings to review the data safety, the first of which will 
be held prior to initiation of the trial to discuss the protocol, approve the commencement of 
the trial, and approve the plans for monitoring the study. Meetings with the safety officer will 
be determined by the PI and will be closed to the public because of confidentiality 
considerations. An emergency meeting may be called at any time by the Safety Officer, or by 
the PI, should questions of participant safety arise. 
 

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20 
 
Dr. Paul Gubanich, Division of Sports Medicine, will serve as a study monitor for this 
project, 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. 
 
(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 participants 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 first testing session and 
a $100 Clincard Mastercard® gift card for completing the final testing session. Participants 
who sustain a clinically diagnosed concussion will also receive $50 for each completed 
session following new concussion diagnosis.  Registration in the Clincard payment system 

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requires a social security number, which will be acquired via a complete W-9 form for each 
participant. 
 

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