Novel Protection Against Potential Brain Injury During Competitive Football Head Impacts
Phase: NA
Conditions: Concussion
Sponsor: Children's Hospital Medical Center, Cincinnati

STUDY TITLE: Novel protection against potential brain injury during competitive football 
head impacts 
 
IRB#: 2015-2205 
NCT#: NCT02696200 
Approval Date: 05/05/2015 
 
 

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CINCINNATI CHILDREN’S HOSPITAL MEDICAL CENTER 
 
STUDY TITLE: Novel protection against potential brain injury during competitive football 
head impacts 
 
INVESTIGATOR INFORMATION: 
Gregory D. Myer, PhD 
 
(513) 636-0249 
 
Principal Investigator Name  
Telephone Number 
 
 
CO-INVESTIGATORS:  
Kim Barber Foss, MS ATC 
Adam Kiefer, PhD 
 
 
(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 that applies mild jugular compression according to the principle of the 
Queckenstedt Maneuver (the Device) 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 2011; Smith 2011; Smith 2012) has 
been approved for studies in humans and the results indicate safety for use during high 
demand and maximal exertion activities, Study ID: 2013-2240, Institutional Review Board - 
Federalwide Assurance #00002988). 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 
collision sport such as football. The use of helmets during such a high-risk sport will allow 
for collision measurement devices to be embedded in the helmet and will not affect play or fit 
of equipment. 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. By 
the nature of the sport selected, it is likely this pilot study will primarily include males, 
however if any female meets inclusion criteria on the team selected, she will be included in 
this investigation. The helmets of all participants will be outfitted with an accelerometer 
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 football 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. 
 

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(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 football playing athletes wearing 
the Device and compared to a similar population not wearing the device. Secondly, the 
purpose 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. The January, 2008 New England Journal of 
Medicine reports, “Head and neck injuries, including severe brain trauma, have been reported 
in one quarter of service members who have been evacuated from Iraq and Afghanistan”(Okie 
2005; Xydakis 2005; Hoge 2008). The vast majority of these injuries have resulted from 
exposure to improvised explosive device (IED) blast waves. Head injuries, concussions and 
the resulting trauma have been in public discussion recently as the National Football League 
(NFL) deals with a lawsuit regarding head injuries by about one-third of living former NFL 
players.  
 
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 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 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 2012; Turner 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 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), 

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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 
2012; Turner 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 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 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 

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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 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 2014) For athletes in the non-intervention 
group, radial diffusivity (RD, DTI parameter associated with white matter structural 
integrity(Song 2003; Song 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, for the first time, that it is possible to protect the brain from sports related head 
impacts.  
  
(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 65 minutes or less (see Table 1 for detailed specifications). 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
Time (min)
Mode
Analysis
3D T1
5
Anatomy
Visual / Volumetrics
DTI
11
WM microstructure
Visual/ROI/TBSS 
or 

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other
rs-fMRI
10
Connectivity/networks
Quantitative
SWI
6
Hemorrhagic Injury
Visual 
(Automated 
analysis) 
HARDI
10-12
WM microstructure
Quantitative
 
(5) DURATION: 
The study recruitment and intervention will occur during one season. Each participant will 
participate in 2 planned study visits that may take up to 2 hours. Data analysis will continue 
for a 2 year period following the final enrollment.  
 
(6) SELECTION & RECRUITMENT OF PARTICIPANTS: 
The purpose of the present study is to generate pilot data for effect size estimation and power 
analysis for future study. The group size proposed in the aims was determined empirically 
based on previous neuroimaging studies and study designs reported in the literature. The 
sample size proposed in this pilot study will not warrant extensive statistical analysis to test 
the listed hypothesis. This study is expected to lead to an accurate estimate of effect size and 
variability so that future studies can be designed more rigorously. 
 
We will recruit up to 60 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. The high- 
risk sports which utilize helmets during competition will allow for measurement devices to 
be embedded in the headgear and will not affect play or fit of equipment. By the nature of the 
sports selected, it is likely this study will primarily include males, however if any female 
meets inclusion criteria on the team selected, she will be included in the investigation. 
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: 
 Normal healthy volunteer  
 Able to provide written consent 

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 Must be 14 years or older and a participant on varsity level high school football 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. A copy of the informed consent will be provided to the participant at this time. 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 
 
MR imaging data Acquisition 

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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 will 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, leg length 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. 
Neck Measurement: We will measure the circumference of your neck with a measuring 
tape. 

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Station II – Neurocognitive Assessment 
Neurocognitive testing will take place as participants will take the web version of ImPACT 
(Immediate Post-Concussion Assessment and Cognitive Testing). Neurocognitive testing is 
utilized in concussion management and ImPACT provides measures of verbal and visual 
memory, processing speed and reaction time. All participants will complete web-based 
ImPACT prior to participation in each experimental session and following any diagnosed 
concussion injury. 
 
Station III - Reaction Time Testing on Smart Phone 
 
 
The participants will be asked to perform simple visual and auditory reaction time testing 
using a customized smart phone application in which a tone plays/the screen changes color 
and the participant has to remove his finger as quickly as possible over 30 response trials.  
 
Station IV – 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 
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. An auditory 
tone will also sound concurrently with each target jump. The test sequence will include 49 
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).  
 
 
Smooth pursuit tracking. Smooth pursuit tracking will be tested as the participant 
attempts to fixate and track the center of a horizontally moving stimulus on the computer 
screen. The stimulus will include a target moving in a predictable sinusoidal pattern with a 
peak velocity of 20, 40, and 60˚/s and a target moving in a random pattern with a mean peak 
velocity of 80˚/s. The duration of each test will be 40 s and this assessment will consist of six 
trials (2 per condition). Dependent measures for smooth pursuit tracking will include: (1) 

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average eye peak velocity (˚/s) after removal of all saccades from the tracking performance, 
and (2) 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. 
 
 
Smooth pursuit tracking and occlusion. Smooth pursuit tracking will also be tested as the 
participant attempts to track the center of a horizontally moving stimulus prior to and after it 
becomes occluded as it moves on the computer screen. The stimulus will be the same as the 
smooth pursuit tracking mentioned above, however for 1000 ms, the target will become 
occluded and the participants will have to resume tracking the target object once it comes 
back out from behind the occluder. 
 
Station V – Electroencephalogram (EEG) 
The following cognitive tests will be performed while EEG/ERP data is collected: 
Auditory oddball task. The oddball task is a classic EEG paradigm that has been 
extensively used for many years, in numerous studies and in many neurological patient 
populations. It is considered to involve executive functions, attention and memory 
processes. The main ERP components are N100 (low level stimulus processing) and 
P300 (attention allocation and stimulus evaluation), which is maximal at fronto-central 
areas for novel stimuli and centro-parietal for Target stimuli. In this task sounds are 
presented, at an average rate of 1 every 1.5sec. A total of 80% of the sounds ("standard') 
are tones of repeating frequency and intensity. A total of 10% of the sounds ("target") are 
tones of another frequency to which participants respond by pressing a button. The 
remaining 10% of sounds ("novel") are multi-frequency sounds, different for each trial. 
The test takes approximately 11 min to complete. 
 
Go-No Go test. The Go-No Go paradigm is among the most well-established tests of 
response inhibition to perceptual stimuli. Go-No Go tasks involve the presentation of a 
continuous series of “Go” or target cues to which participants are asked to respond as 
quickly as possible, and “No Go” or distracter cues that require participants to inhibit 
motor responses. Studies involving ERP have identified a negative-going component 
occurring at 200 – 400 ms following the No Go stimulus known as the “No Go N2”, 
which occurs maximally at frontal-central scalp locations. On No Go trials, the N2 is 
followed by a positive-going shift. This positive complex, termed the “No Go P3”, also 
occurs maximally at frontal-central scalp sites and is typically seen 300 – 700 ms 
following the No Go stimulus. The Go-No Go task takes approximately 9 min to 
complete. 
 
Resting EEG. 4 min resting EEG will be recorded at the end of the tasks, with 
participant fixating at the center of the screen, 2 min with eyes open and 2 min with eyes 
closed. 
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 random 

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Figure 3. illustrates the steps that will be initiated when 
a concussive event is observed.
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.  
  
New Concussion Surveillance and Follow-up: Each helmet of the study participant will be 
instrumented with a GForce Tracker™ (GFT; gForceTracker, Markham, Ontario)) 
accelerometer device. The GFT will be affixed to the inside of each participant's helmet. The 
GFT is equipped with electronics that allow for the measurement of linear accelerations and 
rotational velocities of the head. The GFT measures 6 degrees of freedom by directly 
measuring three axes relative to linear acceleration and three axes relative to angular 
velocity. The GFT stores all impacts locally. These devices need to be connected physically 
to a computer, and data can only be accessed with a unique username and password only 
known to the research team. Accelerometer tracking and management will occur at every 
game and practice by the team Athletic Trainer (AT). 
 
GFT is a small and durable device that is attached to or embedded in any helmet to track 
impacts, and it stores data for uploading to a PC. The GFT software converts tracker data in 
real-time for player and team analysis. This software accurately measures the severity of 
impacts by converting data such as high impact collision into usable reports. De-identified 
impact data are then transmitted to a cloud-based server, accessible only to researchers on 
this protocol via a unique username and password. GFT data will be used in final analysis to 
normalize the exposures to potential concussive events. All impact 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.  
  
The study participants will also 
be monitored on a weekly basis 
for athletic exposures, and new 
concussion injury 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 

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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 and repeated at the conclusion of 
this session. Additional neurologic testing is done on athletes with confirmed or suspected 
concussion to narrow down neuro-systems involved. Concussion evaluations will be repeated 
as needed until the MD is satisfied that the athlete has fully recovered from the concussion. 
This includes a return to baseline at rest, no exam abnormalities, and baseline symptoms with 
sports-specific exertion; whereupon the athlete will be cleared for return to activity. The 
amount of time the athlete was considered unfit to play will also be considered as one of the 
endpoints of this study. If any athlete choses to stop participation in the sporting activity 
following a concussion then they will also be withdrawn from the study, due to no longer 
meeting inclusion criteria. 
 
(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 

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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. 
 
BNA Analysis EEG signals recorded will be cleaned by standard procedures, band pass 
filtered into overlapping physiological frequency bands, cut into epochs around sufficient pre 
and post stimulus onset times, and averaged to result with event related potentials (ERPs). 
For each band, the data is reduced into a set of discrete points that denote local extrema, the 
latencies and amplitudes of which are inputted to the algorithm. The algorithm then seeks a 
state-unique multi-sited spatiotemporal pattern. This is the BNA group network. Following 
that, a BNA score is computed for each participant individually. It is comprised of a set of 
similarity measures to a BNA group network or a group of BNA networks. Once normative 
data is established, patients who require assessment of their brain electrophysiological 
activity will undergo BNA analysis, and their scores will be compared to the BNA pattern of 
the normative data. 
For the group analysis, the raw EEG of each participant undergoes three separate processing 
stages: (1) preprocessing (artifact removal, band-passing); (2) salient event extraction 
(discretization, normalization) and (3) network analysis (unitary events extraction, pair-
pattern extraction) on all salient events gathered from all of the participants. The single 
participant level process involves three stages – the first two are identical to the first two 
stages of the group level process. In the third stage, the single participant activity is 
algorithmically compared to the set of patterns collected during the group analysis stage (see 
below). 
The SIn (network) of a pair-pattern is 1 if it applies at all to a tested participant (i.e., the 
participant’s electrode activity fulfilled the constraints set by the pair-pattern) and 0 if it does 
not. To assess the SIs (synchronicity) of all pair-patterns with an SIn of 1, the times of the 
discrete activity points of the individual participant are compared to the mean and SD of the 
activity times of the respective group pair-patterns. The SIa (amplitude) of the pair is 

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evaluated in a similar manner, by comparing the amplitudes of the activity points. The 
overall BNA score of the individual participant to each of the groups is computed by 
averaging the products WI (weight index) x SI (synchronicity index) of all pairs in all 
patterns of the group. For each participant, the classification score is computed separately for 
each similarity index such that three classification scores were computed: a network score, a 
synchronization score and an amplitude score:  
 
 
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 
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, 

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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: 
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). All functional and 
neurocognitive testing will be performed at the Cincinnati Children’s Hospital Human 
Performance Laboratory. 
 
(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 

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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 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 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 1950; Torres 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 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 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 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 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 2012; Turner 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). 
 

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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 will 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 
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 

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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. 
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.  
 
A study participant may be withdrawn from the investigation if they demonstrate repeated 
alteration in their proper football tackling technique, such as adoption of spearing tackling 
tendencies. Subject participation will also 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; 

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• 
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. 
 
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 

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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. 
 
 

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