Effectiveness of a Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion Injuries in Student Athletes
Phase: NA
Conditions: Concussion, Brain
Sponsor: CentraCare

 
HSR# 17-4360 
Revised 12/14/16, Revised 6/9/17, 6/21/17, Revised 7/12/17  
 
FULL PROTOCOL 
EFFECTIVENESS OF A NECK STRENGTHENING PROGRAM FOR THE 
PREVENTION OR MITIGATION OF SPORTS CONCUSSION INJURIES IN STUDENT 
ATHLETES 
 
Investigator: 
Uzma Samadani, MD PhD 
Rockswold Kaplan Endowed Chair for Traumatic Brain Injury 
Hennepin County Medical Center 
Associate Professor Department of Neurosurgery 
University of Minnesota 
701 Park Ave. PL.610 
Minneapolis, MN 55415 
Email: uzma@samadani.com 
 
Co-Investigator: 
Thomas Bergman, MD 
Chief of Neurosurgery 
Hennepin County Medical Center 
Assistant Professor Department of Neurosurgery 
University of Minnesota 
701 Park Ave. P5 
Minneapolis, MN 55415 
Email: Thomas.bergman@hcmed.org 
 
 
 
 

 
HSR# 17-4360 
Revised 12/14/16, Revised 6/9/17, 6/21/17, Revised 7/12/17  
TABLE OF CONTENTS 
1 Summary ............................................................................................................................. 4 
2 Background ......................................................................................................................... 4 
3 Study Purpose ..................................................................................................................... 4 
4 Study Protocol ...................................................................................................................... 5 
4.1 
Overview .............................................................................................................. 5 
4.2 
Study Design and Methods-Brief ......................................................................... 5 
Table 1: Study Design Summary .................................................................................. 5 
4.3 
Study Objective .................................................................................................... 7 
4.4 
Study Hypotheses ................................................................................................. 7 
4.5 
Study Eligibility and Enrollment ......................................................................... 7 
4.5.1 
Study Population .............................................................................................. 7 
4.5.2 
Duration of Investigation ................................................................................. 7 
4.5.3 
Informed Consent ............................................................................................. 8 
4.5.4 
Subject Selection and Enrollment Procedures ............................................... 8 
4.5.5 
Inclusion Criteria/Exclusion Criteria .............................................................. 8 
4.6 
Study Treatment ................................................................................................... 9 
4.7 
Assessments (baseline through end of study) ...................................................... 9 
4.8 
Study Timeline ................................................................................................... 10 
4.8.1 
Screening/Baseline: ........................................................................................ 10 
4.8.2 
Regular Training Assessments (every 4 weeks): ......................................... 10 
4.8.3 
Following a Diagnosis of Concussion (within 1 day of event): .................. 10 
4.8.4 
Following a Diagnosis of Concussion (7 days after event): ........................ 10 
4.8.5 
Following a Diagnosis of Concussion (30, 60, 90 days after event): ......... 10 
4.9 
Concussion and Adverse Event Recording ........................................................ 11 
5 Investigator Training .......................................................................................................... 11 
5.1 
Subject Training ................................................................................................. 11 
6 Evaluation of Outcomes ..................................................................................................... 11 

 
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6.1 
Safety .................................................................................................................. 11 
6.2 
Outcome Assessment ......................................................................................... 12 
6.3 
Statistical Methods ............................................................................................. 12 
6.4 
Sample Size Determination ................................................................................ 12 
6.4.1 
Data Analysis and Complicating Considerations ......................................... 12 
7 Investigator Responsibilities and Obligations .................................................................... 13 
7.1 
Investigator Responsibilities .............................................................................. 13 
7.1.1 Investigator Accountability .................................................................................. 13 
7.1.2 
Patient Accountability .................................................................................... 13 
7.2 
Investigator Reports ........................................................................................... 13 
7.3 
Investigator Records........................................................................................... 14 
7.4 
Monitoring .......................................................................................................... 14 
7.5 
Screened Subjects Not Enrolled ......................................................................... 14 
8 Reimbursements ................................................................................................................. 15 
8.1 
Subject Compensation ........................................................................................ 15 
 

1 
SUMMARY 
This project will assess the relationships between neck strength and the incidence, 
severity, and duration of concussions in student athletes in order to evaluate the effectiveness 
of a neck strengthening training regime as a primary intervention for reducing the risk of 
sport-related concussion. 
2 
BACKGROUND 
Sport-related concussion is a common injury that results in more than 200,000 
emergency department visits annually, 65% of which are children aged 5 to 18.1 Recognized 
as a major public health concern,2 sport-related concussion diagnoses in the United States 
have increased by 43% overall over the last 5 years.3 Rates of increase over the same time 
span were also found to be higher for pediatric (71%) and female (up to 118%) populations, 
consistent with research indicating that the incidence and clinical outcomes of concussion 
vary with sex and age4; specifically, significantly higher risks and poorer outcomes have been 
reported for younger and female populations.1,5-8 Because the developing brains of children 
and adolescents are uniquely vulnerable to diffuse brain injury,9 single or repeated 
concussions have potential for severe acute and long-term complications in these young 
athletes.10,11  
Low neck strength is a risk factor thought to contribute to an elevated concussion risk.2,12 
Previous studies have shown that athletes with smaller and weaker necks experience greater 
resultant linear and angular head displacements, velocities, and accelerations after 
impact.2,6,13,14 Because these parameters represent the primary mechanisms contributing to a 
concussive event, further studies clarifying the relationships between neck strength and the 
risk and clinical outcomes of concussion are warranted. To date, only 1 study has examined 
the relationship between neck strength and concussion incidence; in a prospective study of 
high school athletes, Collins et al12 measured isometric neck strength parameters using a 
hand-held tension scale and monitored the concussion rate over several sports sessions. Neck 
strength was found to be a significant predictor of concussion incidence among high school 
students, with concussed athletes demonstrating 11% to 22% reduction in neck strength 
compared with nonconcussed athletes.  
Given the increases in the reported incidence of head injuries sustained by young student 
athletes in the United States, it is essential that high school and university athletics programs 
have access to inexpensive, effective, and easy-to-implement strategies for the prevention of 
concussions. Collectively, the results of previous studies suggest that interventions aimed at 
increasing athletes’ neck strength may be effective for decreasing the risk and symptoms of 
concussion. Imperative to the development of such interventions are additional studies that 
quantify the extent to which the severity and duration of concussion symptoms are a function 
of neck strength. 
3 
STUDY PURPOSE 
The purpose of the project is to evaluate the effectiveness of neck strengthening as a 
primary prevention mechanism against concussion. 

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4 
STUDY PROTOCOL  
4.1 
 OVERVIEW 
This project has the following goals: 
1. Determine whether baseline measurements of neck strength correlate with the 
incidence, severity, and duration of concussion symptoms;  
2. Determine whether a standardized neck strengthening training regime reduces the 
risk of concussion and the severity and duration of symptoms; and  
3. Determine whether the relationships between neck strength and the clinical 
symptoms of concussion are independent of gender.  
Subjects aged 5 to 22 who are involved in organized, academic or community-based 
contact/collision sports activities at Gustavus Adolphus College, member schools of the 
Independent Metro Athletic Conference (IMAC) conference, and The Sanneh Foundation 
participate in an instructor-led neck-strength training program. Subjects enrolled in the study 
will be followed for up to 3 years to assess whether the incidence, severity, and duration of 
concussion symptoms varies as a function of neck strength in young athletes. Anthropometric 
measurements, neck strength parameters, cognitive assessments, and an eye-tracking 
assessment will be performed for each subject at baseline, and at yearly intervals thereafter in 
the absence of a reported head injury. In addition, anthropometric and neck-strength 
measurements will be recorded at regular intervals during the study to quantify the 
effectiveness of the strength training regime. Subjects diagnosed with concussion during the 
study will be assessed for the severity and duration of postconcussion symptoms using eye-
tracking methodology and traditional cognitive assessments. Clinical outcomes will be 
assessed immediately following a concussive event and monitored by research staff until 
symptoms resolve. Data will be collected by onsite study volunteers trained by Dr. Uzma 
Samadani or another member of the Brain Injury Research Lab staff at HCMC. All aspects of 
the study design will be overseen and approved by Dr. Thomas Bergman. 
4.2 STUDY DESIGN AND METHODS-BRIEF 
Table 1: Study Design Summary 
STUDY TYPE 
Multicenter, observational, open analytical study 
SAMPLE SIZE 
1500 
SITES 
Sports facilities onsite at Gustavus Adolphus, member schools of the 
IMAC conference, and The Sanneh Foundation. 
 
STUDY DURATION Approximately 3 years 
 
STUDY ARM(S) 
Single-arm design 

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All subjects will undergo an instructor-led, standardized neck-
strengthening training regime  
 
STUDY DESIGN 
Subject recruitment and enrollment 
Subjects (aged 5-22) involved in contact/collision sports programs 
will be recruited from and enrolled at schools and community-based 
sports facilities.  
 
Intervention 
Subjects will be invited to participate in a twice-weekly, instructor-
led, neck-strengthening training program. In each training session, 
subjects will perform a variety of lightly-weighted and nonweighted 
resistance exercises. 
 
Assessments and timeline 
Demographic and sport history information will be collected at 
screening, and morphometric, cognitive, neck-strength, and eye-
tracking assessments will be made at baseline, and annually thereafter 
in the absence of a reported head injury. In addition, anthropometric 
and neck-strength measurements will be recorded immediately before 
and after training sessions at 6-month intervals to track improvements 
in neck strength. Subjects who experience concussion during the 
study will undergo assessments for eye-tracking and cognition at the 
time of the event; a subset of cognitive assessments will also be made 
on a daily basis following the event, until full recovery is achieved. If 
recovery is not achieved within a week, eye-tracking will be repeated. 
If symptoms continue to persist, additional cognitive assessments will 
be administered and repeated monthly until the subject fully recovers.  
 
Data analysis 
Repeated-measures analysis of variance (ANOVA) will be used 
to evaluate the effectiveness of the training program for 
increasing neck strength. Relationships among neck-strength 
parameters and concussion risk and functional outcome measures 
will be evaluated via logistic and linear regression models. Analyses 
will be adjusted for sex to evaluate whether the results are 
independent of gender. 
   
SCHEDULE  
Week 1: Initial visit or call prior to enrollment to obtain  
informed consent; Baseline assessments made within 72 hours of 
enrollment 
Weeks 4 to 52: Assessments of neck strength made at 6-month 
intervals (+/- 3 days)a 
Weeks 4 to 52: Assessments of concussion symptoms (if applicable) 
until symptoms resolve. 

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 Time-of-event (within 1 day of event): Cognitive and eye-
tracking assessments 
 Days 1-7 after event: Daily subset of cognitive assessments 
 Day 7: Eye-tracking assessment, neck-strength measurement 
 Weeks 4, 8, and 12 after event (+/- 3 days): Cognitive 
assessments 
 
aThe neck-strengthening training regime will be administered for the 
length of the subject’s sport program and during the period(s) of time 
corresponding to the subject’s regular athletic training schedule. 
   
BLINDING 
This study is nonblinded.  
 
4.3 STUDY OBJECTIVE 
The primary objective of the study is to evaluate the impact of neck strength on the 
incidence and clinical outcomes of concussion among young athletes.  
  
The study also generally aims to determine if implementation of a neck-strengthening 
program can significantly reduce the duration and severity of concussion symptoms in young 
athletes.  
4.4 STUDY HYPOTHESES 
The primary study hypothesis is that increased neck strength reduces in the incidence, 
severity, and duration of concussion symptoms.  
4.5 STUDY ELIGIBILITY AND ENROLLMENT 
4.5.1 Study Population 
Subjects will be youths aged 5 to 22 who are involved in one or more academic or 
community-based organized contact/collision athletic sports program(s). Approximately 1500 
students will be recruited from Gustavus Adolphus College, member schools of the 
Independent Metro Athletic Conference (IMAC) conference, and The Sanneh Foundation, 
and enrolled in the study. The study population will be composed of players from multiple 
sports, and at a broad range of competitive levels. Study-site coordinators and/or trainers will 
be advised of the purpose and procedures of the study and will refer subjects to the 
Investigator for consideration. Subjects who meet all inclusion/exclusion criteria and have 
appropriate consent to participate in the study may be enrolled. The study is open to all races 
and both genders.  
4.5.2 Duration of Investigation 
Enrolled subjects may be followed for up to 3 years. The duration of training and 
assessment for subjects is anticipated to vary by sport and program. However, all subjects will 

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complete the neck-strengthening training program twice weekly for the duration of time that 
they are enrolled in the study.  
4.5.3 Informed Consent 
Subjects enrolling in the study may not be capable of providing consent in which case 
consent will be obtained from the subject’s parent/guardian/legal representative. Legal 
guardians will be provided with written consent forms detailing all risks, benefits and 
alternatives to subject participation.  
For subjects aged 8 and above, written informed assent will be obtained from the 
subject. Informed consent will include a detailed description of the study, including its 
purpose, procedures, and risks.  
The consent form will include information about the assessments conducted at 
baseline and at follow-up, and a description of the training regime. Research personnel from 
the Brain Injury Research Lab will prepare an informative video to be placed online, as well 
as verbally explain the information provided in the consent form and subjects and their 
representatives will be granted the opportunity to ask unlimited questions in English or any 
chosen language through the availability of a trained medical translation service.  
The subject will be provided with a copy of the IRB-approved/stamped informed 
consent form. The Investigator or designee will ensure that all of the potential subject’s 
questions and those of the subject’s caregiver regarding study participation have been answered, 
and that the potential subject agrees to study participation. Written informed consent will then 
be obtained from the subject or the subject’s legally authorized representative. A copy of the 
signed informed consent form shall be given to the subject/proxy, and the original stored on site 
at the Brain Injury Research Lab. The informed consent process shall be documented in the 
subject’s records. No study-specific procedures will be conducted prior to obtaining consent. 
4.5.4 Subject Selection and Enrollment Procedures 
Study site coordinators at each school or organization who are advised of the purpose 
and procedures of the study and will refer subjects to the Investigator for consideration. Once 
a subject has been identified, he/she will be approached by research personnel from the Brain 
Injury Research Lab or the study site coordinator and informed consent will be obtained prior 
to the screening process. Subjects will be considered enrolled in the study at the time the 
informed consent is obtained and when the subject ID has been assigned. 
4.5.5 Inclusion Criteria/Exclusion Criteria 
Youth athletes screened as potential study subjects must meet all of the following 
inclusion criteria and none of the following exclusion criteria. 
INCLUSION CRITERIA: 
1. Involved in programmatic athletic activities with an ongoing duration of at least  
4 weeks. 
2. Written informed consent obtained by the subject or subject’s legal guardian. 
3. Written assent from subjects ages 8 years old and above 
4. Subject is between the ages of 5 and 22 years, male or female.  

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5. Subjects from all racial and ethnic origins will have an opportunity to participate. 
EXCLUSION CRITERIA: 
1. Corrected vision less than 20/500.  
4.6 
STUDY TREATMENT 
Subjects will engage in an instructor-led, supervised, manual-resistance training 
program twice weekly. At each session, subjects will perform a variety of nonweighted 
resistance exercises, previously shown in a clinical trial to be safe and effective for use in 
pediatric populations (ClinicalTrials.gov identifier, NCT02455037)15 and lightly weighted 
exercises using barbells, and commercial neck strengthening equipment (eg, NekkDekk 
and/or IronNeck).  
The effectiveness of the strength training regime over time will be assessed by 
measuring neck girth and neck strength at the beginning and end of training sessions at 6-
month intervals, for as long as the subject continues the sport program or until he/she leaves 
the study.  
4.7 ASSESSMENTS (BASELINE THROUGH END OF STUDY)  
 
Eye Tracking  
Subjects’ eye movements will be tracked and recorded with an SR Research Eyelink 
1000 eye tracker while a 220-second video was played continuously within a square 
aperture moving around the perimeter of a 17” viewing monitor (aspect ratio 4:3) fixed 
55cm away from the patient. The video aperture size is approximately 1/9th the area of the 
display monitor. The position of the eyes will be obtained at 500Hz with a stabilized chin 
rest to minimize head movement during the eye tracking session. All subjects will be asked 
to take off their glasses while being tracked. The visual stimuli are G-rated music videos, 
children’s movie clips, and other documentary film selections. Subjects will not be spatially 
calibrated to the tracker to enable independent analysis of each pupil position over time. 
The eye tracking data will be processed to yield 89 eye tracking metrics.  
Cognitive Assessments 
Subjects will undergo cognitive assessments which have been previously validated 
in clinical research.   
Morphometric Measurements 
Height and weight will be measured using a standing scale. Head circumference will 
be measured at the top of pinna and neck circumference (girth) will be measured at the level 
of the thyroid cartilage using a flexible metric tape.  
Neck Strength Parameters 

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Neck strength (extension, flexion, left and right lateral measurements) will be 
assessed using a hand-held commercial dynamometer that is effective for measuring neck 
strength.16 Subjects will be permitted to rest between measurements to minimize risk of 
injury. 
4.8 
STUDY TIMELINE 
4.8.1 Screening/Baseline: 
Once a potential study subject is identified, informed consent will be obtained.  After 
this, patients will be asked or undergo 
 General medical questions to affirm inclusion/exclusion criteria 
If they are eligible for enrollment, they will then undergo: 
 Training on all aspects and requirements of the study, including the neck-strengthening 
training program, concussion and adverse event reporting, and frequency and 
expectations for follow-up measurements of neck strength 
 Morphometric assessments 
 Cognitive evaluations  
 Eye-tracking algorithm 
 Neck-strength assessment 
4.8.2 Regular Training Assessments (every 6 months):  
 Review subject’s impressions of the training program 
 Morphometric and neck-strength measurements immediately before and after the 
training session 
4.8.3 Following a Diagnosis of Concussion (within 1 day of event):  
 Review subject’s general well-being 
 Cognitive evaluations  
 Eye-tracking algorithm 
 Neck-strength assessment 
 Date of last menstrual period (females only) 
If concussion symptoms persist: 
4.8.4 Following a Diagnosis of Concussion (7 days after event):  
 Review subject’s general well-being 
 Cognitive evaluations  
 Eye tracking algorithm 
 Neck-strength measurements 
4.8.5 Following a Diagnosis of Concussion (30, 60, 90 days after event):  
 Review subject’s general well-being 
 Cognitive evaluations  

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4.9 CONCUSSION AND ADVERSE EVENT REPORTING 
Athletic trainers will inform study site coordinators if a concussive event is suspected. 
The subject will be removed from activity and ultimately returned to activity as per their 
school or program protocol. The study site coordinator will immediately inform the 
Investigator of the event.  
Monitoring of potential adverse events will be performed on a continuous and ongoing 
manner by the Investigator, research staff, and/or experienced athletic trainers at each study 
site. The nature of each adverse event, date and time of onset (when appropriate), outcome, 
frequency, maximum intensity, action taken, and attribution of each event will be recorded 
to identify those that are potentially related to the intervention (ie, the training regime). If an 
adverse experience increases in frequency or severity during the study period, a new 
record of the experience will be started. 
 
5 
INVESTIGATOR TRAINING 
Study-site coordinators, athletic trainers at each site, and site volunteers will 
receive practical training in the execution of the neck-strengthening program, recognition 
of the symptoms of concussion, and data collection methods prior to the start of the 
study. 
5.1 SUBJECT TRAINING 
The Investigator or his/her designee will train the subjects on the correct execution 
of the resistance training movements, and will document this training in the subject 
records. Training will include the following steps and tools: 
 Review all precautions and potential risks associated with participation in 
the training program 
 Review the execution of each exercise move and the use of any 
applicable associated equipment 
 Invite the subject to ask questions about the exercises or program 
Subjects may also contact the Investigator or study-site coordinator at any time 
during the study to ask questions or request additional training/retraining. 
6 
EVALUATION OF OUTCOMES  
6.1 SAFETY 
The safety of the neck-strength training program will be measured and evaluated 
by the incidence of injuries or other adverse events related to the study treatment.  
Improper execution of the exercises will be considered in the review of potential 
causes for any intervention-related or possibly intervention-related adverse events during 
the study. Any injury or other adverse event that is determined by the Investigator or the 

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Investigator’s designee to be related or possibly related to the training program will be 
followed-up with the study subject, athletic trainer or study-site coordinator, and/or the 
subject’s parent/guardian/legal representative to obtain wider perspective on the factors that 
led to the event.   
6.2 
OUTCOME ASSESSMENT 
Outcomes will be assessed by an experienced researcher with neurologic and 
cognitive evaluations that are commercially available and validated in traumatic brain injury 
or cognitive dysfunction. Subjects will be followed for a minimum of 4 weeks after 
enrollment and a minimum of 1 week following a concussive event unless they or their legal 
guardians choose to leave the study. 
6.3 
STATISTICAL METHODS 
Data accrued through this study will be reviewed with statisticians from The 
Minnesota Medical Research Foundation Chronic Disease Research Group. Repeated-
measures analysis of variance (ANOVA) will be used to evaluate the effectiveness of 
the training program for increased neck strength. Relationships among neck-strength 
parameters and concussion risk and functional outcome measures will be evaluated via 
logistic and linear regression models. Analyses will be adjusted for sex to evaluate whether 
the results are independent of gender. 
6.4 SAMPLE SIZE DETERMINATION 
Sample size estimates were calculated based on unpublished data indicating an incidence 
of concussion of 11%, and published data on the reduction in concussion risk associated with 
increased neck strength.12 Based on this information, a sample of size of 1198 subjects would 
be needed to detect a correlation of R=0.25 between neck strength and a reduction in the 
severity of concussion symptoms (based on cognitive assessment scores) with a power of 0.8 
at alpha=0.05. Assuming attrition of 15-20%, we therefore believe that approximately 1500 
subjects will be needed.  
 
6.4.1 Data Analysis and Complicating Considerations 
A potential limitation on data interpretation is that substantial asymmetry in the 
number of enrolled males vs females could reduce the potential to detect an effect of neck 
strength on concussion risk. This is more likely to occur if the enrolled population is heavily 
skewed towards males because of the lower incidence rate of concussion in this 
demographic. All efforts will be made to enroll a study population with a 50% male-to-
female ratio. We will consult with a biostatistician if this target is not reached to reevaluate 
the adjusted minimum sample size required to detect an effect.    

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7 
INVESTIGATOR RESPONSIBILITIES AND OBLIGATIONS 
7.1 
 INVESTIGATOR RESPONSIBILITIES 
7.1.1 Investigator Accountability 
The Investigator is ultimately responsible for equipment accountability including 
but not limited to hand-held tension devices and eye trackers. The study-site coordinators, 
or designees, are responsible for maintaining site logs of equipment accountability and 
use, which will include tracking the receipt and return/disposition of all equipment 
used in the study (if applicable). 
7.1.2 Patient Accountability 
A subject /subject caregiver may withdraw their consent to participate in the study at 
any time and can do so by notifying the Investigator and/or Investigator staff. 
7.2 
INVESTIGATOR REPORTS 
The Investigator will be responsible for the following 
reports:  
Adverse Events: 
Adverse events will be reported to the reviewing IRB in compliance with its reporting 
requirements. For serious adverse events (whether or not related to the intervention) or 
unanticipated adverse effects of the intervention, this will occur no later than 5 business 
days of the Investigator becoming aware of the event. 
Deviations from the Investigational Plan: 
The Investigator is responsible for reporting all protocol deviations. Examples of protocol 
deviations include, but are not limited to: 
 
Failure to obtain written informed consent prior to conducting  
study procedures 
 
Failure to comply with any requirements of the reviewing IRB  
Progress Reports: The Investigator is required to submit annual progress reports to the 
reviewing IRB. Reports must include the number of study subjects, a summary of all 
follow up evaluations, a summary of all adverse events and a general description of the 
study's progress. 
Final Report: The Investigator will submit a final report to the IRB within 3 
months of termination of the study or termination of that Investigator's 
participation in the study. 

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7.3 INVESTIGATOR RECORDS 
The Investigator will maintain complete, accurate and current study records, including 
the following materials: 
 Study subject records, including signed informed consent forms and copies of all data 
collection forms 
 
Documentation of any participation in the study without informed consent and a 
brief description of the circumstances justifying the failure to obtain informed 
consent  
 
All relevant observations, including records concerning adverse effects of the 
training regime (whether anticipated or unanticipated) 
 
Current study protocol and documentation of protocol deviations, including details 
of any reason for deviations from the protocol that could affect the scientific 
quality of the study or the rights, safety, or welfare of the subjects, 
 
The IRB-approved blank informed consent form and blank data collection forms  
 
Certification that the investigational plan has been approved by all of the 
necessary approving authorities 
 
Signed and dated letters of agreement among the Investigator and all participating 
study site organizations. 
These records shall be maintained for a period of 2 years after the date on which the 
investigation is terminated or completed. 
7.4 MONITORING 
After commencement of the study, regular monitoring will be conducted  
to ensure: 
 Ongoing compliance with the study protocol 
 Ongoing compliance with any conditions of approval of the reviewing IRB 
7.5 SCREENED SUBJECTS NOT ENROLLED 
Only data for enrolled subjects will be monitored and entered into the database. 
Of those subjects who have consent and are screened for the study but are not enrolled for 
any reason will not be followed and their data will not evaluated, except as may be necessary 
to assess the reason for the screening failure. The sites may retain the informed consent 
form and screening documentation for these subjects at their discretion. 

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8 
REIMBURSEMENTS  
8.1 SUBJECT COMPENSATION 
There will be no costs to the subject or payment for participation in the study to 
subjects or their legal proxies.  
 
REFERENCES 
1. 
Centers for Disease Control. Nonfatal traumatic brain injuries from sports and 
recreation activities--United States, 2001–2005. Morb Mortal Wkly Rep. 
2007;56(29):733–737. 
2. 
Eckner JT, Oh YK, Joshi MS, Richardson JK, Ashton-Miller JA. Effect of neck 
muscle strength and anticipatory cervical muscle activation on the kinematic response 
of the head to impulsive loads. Amer J Sports Med. 2014;42(3):566-576. 
3. 
Blue Cross Blue Shield. The steep rise in concussion diagnoses in the United States. 
https://www.bcbs.com/about-us/capabilities-initiatives/health-america/health-of-
america-report/steep-rise-concussion. 2016. 
4. 
Hildenbrand KJ, Vasavada AN. Collegiate and high school athlete neck strength in 
neurtral and rotated postures. J Strength Cond Res. 2013;27(11):3173-3182. 
5. 
Field M CM, Lovell MR, Maroon J. Does age play a role in recovery from sports-
related concussion? A comparison of high school and collegiate athletes. J Pediatr. 
2003;142(5):546-553. 
6. 
Tierney RT, Higgins M, Caswell SV, et al. Sex differences in head acceleration 
during heading while wearing soccer headgear. J Athlet Train. 2008;43(6):578-584. 
7. 
Dick RW. Is there a gender difference in concussion incidence and outcomes? Brit J 
Sports Med. 2009;43:I46-I50. 
8. 
Covassin T, Swanik CB, Sachs ML. Sex differences and the incidence of concussions 
among collegiate athletes. J Athlet Train. 2003;38(3):238-244. 
9. 
Daneshvar DH, Riley DO, Nowinski CJ, McKee AC, Stern RA, Cantu RC. Long-term 
consequences: effects on normal development profile after concussion. Phys Med 
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