Notre Dame Footballers
Medical Research Project*

Boston University School of Medicine

Updated: February 1, 2019
Boston University (BU) Investigators
Principal Investigator:
Robert A. Stern, PhD, Professor of Neurology, Neurosurgery, and Anatomy &
Neurobiology; Clinical Core Director, BU Alzheimer’s Disease Center (ADC);
Director of Clinical Research, BU CTE Center; Boston University School of
Medicine (BUSM)
Co-Principal Investigator:
Michael L. Alosco, PhD, Assistant Professor of Neurology; Investigator, BU ADC and BU
CTE Center; BUSM;
Investigator and Study Neurologist:
Jesse Mez, MD, MS, Assistant Professor of Neurology; Clinical Core Associate Director,
BU ADC; Investigator, BU CTE Center; BUSM
Biostatistician and Co-investigator:
Yorghos Tripodis, PhD, Research Associate Professor of Biostatistics, BU School of
Public Health (SPH); Data Management and Biostatistics Core Director, BU
ADC; Investigator, BU CTE Center; BUSM
This Project Is Being Conducted In Partnership With The Independent
Notre Dame Footballers Medical Research Project
Players Steering Committee Co-Chairs:
Rocky Bleier, RB #28, ND ’68
David Casper, TE #86, ND ‘74
Vagas Ferguson, RB #32, ND ’80
Project Coordinators:
Edward Ziegler, RB #32, ND ’70
Bill Etter, QB #2, ND ’72
Drew Mahalic, LB #45, ND ’75
Pat Sarb, CB #29, ‘ND ’76
Terry Eurick, RB #40, ND ’78
David Condeni, SE #80, ND ’81
Media Liaison:
Tom Clements, QB #2, ND ’75
Bob Belden, QB #2, ND ‘
John McHale, LB #43, ND ‘71
Luther Bradley, DB #78, ND ‘77
Fund Raising:
Tom Sullivan, OT #55, ND ‘66
George Geoddeke, C #64, ND ’67
Steve Orsini, FB #14, ND’78
Gene Smith, LB #90, ND ’77
Players Physicians Committee:
John Cieszkowski MD, FB #35, ND ‘72
Jim Sheahan MD, DB #16, ND ’71
Max Walsh MD, OT #57, ND ’74
Jim Ryan MD, HB/K #11, ND 1967
Players Participation and Support Committee:
Ross Browner, DE #89, ND ’78
Walt Patulski, DE #82, ND ’72
Luther Bradley, CB #20, ND ’77
Mike Townsend, DHB #27, ND ’74
Mike McCoy, DT #77, ND ’70
George Kunz, OT #78, ND ’69
Scientific and Medical Advisors to Steering Committee:
Randall Benson, MD, Medical Director, Center For Neurological Studies
Charles Bernick, MD, MPH, Associate Medical Director, Cleveland Clinic Las Vegas Lou
Ruvo Center for Brain Health
Jessica Gill, PhD, RN, FAAN, Lasker Clinical Research Scholar, National Institute of
Nursing Research
Larry Latour, PhD, Senior Scientist, National Institute of Neurological Disorders and
Stroke
Robert Driscoll, ND ’77, MD, Chief of Trauma South Shore Health Systems,
Surgical Faculty Harvard Medical School
Background and Significance
Repetitive mild traumatic brain injury (TBI), including symptomatic concussions and
subconcussive trauma, may lead to the neurodegenerative disease, chronic traumatic
encephalopathy (CTE).1-9 Exposure to these repetitive head impacts (RHI) from contact and
collision sport involvement (e.g., tackle football, boxing) has been specifically associated with
post-mortem CTE neuropathology, as well as cognitive (e.g., short-term memory problems and
executive dysfunction, problems in daily living and dementia) and neuropsychiatric (e.g.,
aggression, impulsivity, depression, apathy) decline during life. Our team at the BU CTE Center
diagnosed CTE post-mortem in a convenience sample of 177 of 202 deceased tackle football
players.7 In addition, preliminary findings from our group, of studies examining living former high
school, college, and professional tackle football players, indicated that estimated cumulative
RHI exposure, as well as the age of first exposure (AFE) to tackle football, are associated with
later life cognitive and neuropsychiatric impairment, blood and cerebrospinal fluid biomarkers of
neurodegeneration, and structural brain changes on MRI scans.10-17 CTE and other later-life
neurologic disorders from participation in tackle football is potentially a major public health
issue, given the millions of Americans who have played tackle football and the millions who
currently play.
Despite the growing media attention and public awareness of brain trauma and
neurodegenerative disease associated with American football, the actual risk for long-term
cognitive and neuropsychiatric consequences from playing football is unknown,
particularly at the college level. The existing evidence is limited by small sample sizes,
possible biases from participant recruitment methods, and a focus on former professional tackle
football players. Many millions more play or have played tackle football at the college level and
thus it is this large cohort which could possibly pose the most significant public health concern.
There is, therefore, a need for a large-scale investigation of the cognitive and neuropsychiatric
function of former college tackle football players.
In contrast to the focus these past several years on CTE and related later-life cognitive,
mood, and behavior changes in former football players, there has been very little research on
possible increased risk for other medical conditions in former football players. The limited
research that has been conducted has been on former professional (NFL) players, with very
mixed results.18-24 There is a need to study the prevalence of other medical conditions and
disorders, across all body systems. In particular, because of frequent orthopedic injuries
incurred during football, it is possible that former collegiate players may have an increased
frequency of opioid dependence initiated from later life orthopedic surgery pain management.
The ability to obtain health information and assess the cognitive and neuropsychiatric
functioning of hundreds of former college football players from a single major NCAA college
program, all between the ages of 58 and 75, provides a unique and important opportunity. Prior
to the implementation of this project, the Notre Dame Former Players Medical Research
Association had already undertaken the critically vital tasks of: (1) compiling the contact
information for, or knowledge of death of, 97% of all of the senior varsity football players from
the 17-year period of 1964-1980; (2) developing the trust and interest of their former teammates
to participate in this research; and (3) obtaining the informal support of key members of the
University of Notre Dame leadership. The establishment of a partnership with experienced
researchers from the BU CTE Center now makes possible the design and execution of a
scientifically sound and cost- and time-efficient research project, one that will likely result in
valuable findings pertinent to all of the participating former Notre Dame players, other former
college players from the same era, and all past, current, and future college football players.
Specific Aims
Aim 1. Determine the current overall health status of former Notre Dame football
players.
Aim 2. Characterize the current cognitive and neuropsychiatric functioning of former
Notre Dame football players.
Aim 3: Conduct annual follow-up evaluations of former players to assess future decline
in functioning and/or new disorders/diagnoses.
Methods
Sample
The subjects in this study comprise all of the Notre Dame senior varsity players who
were on the football teams coached by Ara Parseghian during the 11 seasons from 1964-1974
and coached by Dan Devine during the 6 seasons 1975-1980. The total number of players on
those teams is 509. In order to reduce potential ascertainment bias and other potential biases in
the sample, the goal is to gather basic health information on the entire group of 509 former
players, whether currently living or deceased. Former players from those teams have recently
created the Notre Dame Former Players Medical Research Association (a not-for-profit
organization that is independent of the University of Notre Dame). Through formal and informal
approaches, including word of mouth, the members of the Association have developed an up-todate
contact list. Prior to the initiation of this study, the Association had obtained active email
contacts for 407 (79%) of the total 509. They have determined that 89 former players (17%)
have died. There remains 72 former players (14%) for whom there is no currently known contact
information. Staff at the BU CTE Center, working under Drs. Stern and Alosco’s direction will do
extensive online and other research in an attempt to locate contact information for the missing
subjects. In addition, working with the Association, contact information will be sought for the
next-of-kin of the deceased former players in order to contact them to provide medical,
neurologic, psychiatric, substance abuse, cognitive history, and cause of death of their loved
ones.
Confidentiality
Participants (including next-of-kin) will be informed of the extensive steps taken to
assure strict confidentiality of their responses to all questions and surveys, and to cognitive test
results. These include: (1) the responses to all questions and results will be stored in a secure,
password-protected, and encrypted database at the BU School of Public Health; (2) all
responses to questions entered into the database will be de-identified (i.e., name, date of birth,
address, and other personally-identifiable information will be stored separately from the
responses to questions); (3) all study staff undergo confidentiality training and have been
trained and nationally and locally certified in the Protection of Human Subjects; (4) no
personally-identifiable information/responses will be shared with members of the Notre Dame
Former Players Medical Research Association or the University of Notre Dame; and (5) prior to
initiation of the study, the protocol (including methods of obtaining telephone- and/or onlinebased
consent) will be reviewed and approved by the BU Medical Campus Institutional Review
Board (IRB).
Study Design and Data Collection Steps
The data collection methods for this study are designed to maximize enrollment and
participation by obtaining data in a stepwise fashion as seen in the Figure 1. It is anticipated
that all or nearly all former players or next-of-kin will be willing to complete a brief (20-minute)
online questionnaire (or, if telephone interview is requested/required, the same questions asked
by trained research assistants by phone) to ascertain basic medical, neurologic, and psychiatric
history and diagnoses. Participants (or next-of kin) will then be asked to enroll into the existing
BU Longitudinal Examination to Gather Evidence of Neurodegenerative Disease (LEGEND)
Study (PI: Stern), which is one of the few prospective, longitudinal studies of contact sport
athletes. The LEGEND Study began in 2011 and involves telephone-based sport and repetitive
head impact exposure history and cognitive assessments, as well as web-based evaluations of
mood, behavior, and cognition of contact- and non-contact sport athletes across the US (further
methodological details provided below). ~1,000 former and active athletes, including ~500 male
tackle football players, are enrolled in LEGEND, leading to several important published papers
listed below. In the following section, the methods involved for each of the Specific Aims will be
described.
Figure 1 Steps of Data Collection

Aim 1. Determine the current overall health status of former Notre Dame football
players.
Health Survey – Part 1: The former Notre Dame football players (or next-of-kin for
deceased individuals) will be directly contacted through a personalized email (created and sent
through the BU BEDAC) with the sender’s name listed as the names of the three Steering
Committee co-chairs. If a former player is unable to comprehend or adequately respond to the
survey or if he has cognitive impairment resulting in a lack of decisional capacity to provide
consent, a spouse or legally authorized representative for the former player may complete the
initial survey. The email will describe the purpose of the proposed study and the associated
procedures involved, including statements that the study is being conducted through a
partnership with researchers from Boston University School of Medicine and that all responses
will be confidential. Within the email, there will be a link that interested participants can click on
and be directed to a secure, confidential, study-specific website that will provide additional
information, request informed consent, and ask the individual to respond to questions pertaining
to the following: general health status, major medical conditions and neurologic disorders;
diagnoses of mild cognitive impairment (MCI) or dementia (including Alzheimer’s disease
dementia and others); psychiatric and behavioral disorders (including substance abuse); age of
onset of each disorder; and, for deceased individuals, cause of death (completed by next-ofkin).
At the end of this initial survey, all respondents will be given information about Part 2 of the
study involving online cognitive testing, neuropsychiatric questionnaires, and a telephone
interview and asked to participate or find out more information.
Aim 2: Characterize the current cognitive and neuropsychiatric functioning of
former Notre Dame tackle football players, ages 58-74, as well as their estimated
repetitive head impact exposure.
Online Cognitive and Neuropsychiatric Testing – Part 2a: Individuals who respond to the
query at the end of the Part 1 Health Survey that they would like to participate in, or find out
more about Part 2 will be taken to a website landing page specifically designed for the Notre
Dame project. At this landing page, they will find additional information on Part 2 and, if
interested, they will be asked to provide consent to continue.
Four to six months after consenting, participants will receive another email containing a
link to the online cognitive testing portal. The cognitive testing will take approximately 45
minutes and will include the CogState Brief Battery (CBB), Lumos Labs NeuroCognitive
Performance Test (NCPT), and MemTrax Memory Test to highlight aspects of cognition we
believe are affected by repetitive head impacts including episodic memory, executing
functioning, attention, and psychomotor speed among others.
Twenty-four hours after completing the online cognitive testing, participants will receive
an email containing a link and will then be asked to completed online validated self-report
neuropsychiatric questionnaires of executive function (Behavior Rating Inventory of Executive
Function-Adult Version [BRIEF-A]), depression (Center for Epidemiologic Studies-Depression
Scale [CES-D]), daily living activities (Functional Activities Questionnaire [FAQ]), mood and
behavior related to football, (Cognitive Behavioral Mood History [CBMH]), pseudobulbar affect
(Center for Neurologic Study – Lability Scale [CNS-LS]), and apathy (Apathy Evaluation Scale
[AES]). These questionnaires will take approximately 15 minutes to complete. All of these
measures have normative data from which standardized scores will be derived, as well as cutscores
to determine the presence of clinically-meaningful levels of impairment. At the end of
these questionnaires, the participant will be notified that they will be contacted by a member of
the study staff to set up a 20-30 minute telephone-based interview.
Telephone Interview to Determine Estimated Repetitive Head Impact Exposure – Part
2b: After an interview time has been arranged, the study staff will contact the participant and will
interview the participant about their football and other contact sport history (e.g., seasons
played, position played, levels [youth, high school, college, semi-pro, pro) played, as well as
military history and detailed traumatic brain injury history.
Comparison to Normative Data and Known Health Statistics
This study does not involve the concurrent enrollment and participation of a “control
group.” Although the use of control group is often the optimal design for studies aimed at
examining risk of a health/medical issue in a specific population, in some types of research, it is
not possible to define the appropriate control (or comparison) group characteristics. For this and
other reasons (e.g., logistical complexity, lack of funding), some studies, including this proposed
study, are able to examine questions of risk and describe the current level of participants’
functioning by comparing the participants’ data (e.g., diagnoses, performance/responses on
standardized tests, death rate), to available health and mortality statistics for the larger
population (by age, sex, geographic location, etc.) and to published normative data available for
standardized tests (by age, sex, educational attainment).
Select Publications based on the LEGEND Study
- Seichepine DR, Stamm JM, Daneshvar DH, Riley DO, Baugh CM, Gavett BE, Tripodis
Y, Martin B, Chaisson C, McKee AC, Cantu RC, Nowinski CJ, Stern, R.A. Profile of selfreported
problems with executive functioning in college and professional football players.
J Neurotrauma. 2013;30:1299-1304. PMCID: PMC3713446
- Robbins CA, Daneshvar DH, Picano JD, Gavett BE, Baugh CM, Riley DO, Nowinski CJ,
McKee AC, Cantu RC, Stern RA. Self-reported concussion history: Impact of providing a
definition of concussion. Open Access J Sports Med. 2014;5:99-103. PMCID:
PMC4019619
- Alosco ML, Kasimis AB, Stamm JM, Chua AS, Baugh CM, Daneshvar DH, Robbins CA,
Mariani M, Hayden J, Conneely S, Au R, Torres A, McClean MD, McKee AC, Cantu RC,
Mez J, Nowinski CJ, Martin BM, Chaisson CE, Tripodis Y*, Stern RA*. Age of first
exposure to American football and long-term neuropsychiatric and cognitive outcomes.
Translational Psychiatry. 2017:7, e1236. http://rdcu.be/wqd7
- Montenigro PH, Alosco ML, Martin BM, Daneshvar DH, Mez J, Chaisson CE, Nowinski
CJ, Au R, McKee AC, Cantu RC, McClean MD, Stern RA,* Tripodis Y* Cumulative head
impact exposure predicts later-life depression, apathy, executive dysfunction, and
cognitive impairment in former high school and college football players. J Neurotrama.
2017;34(2):328-340. PMCID: PMC5220530
Aim 3: Conduct longitudinal, annual follow-up evaluations of former players to
assess future decline in functioning and/or new disorders/diagnoses.
Each participant will be requested to be contacted annually by study staff to undergo a
follow-up evaluation. These evaluations will be similar to those described above. These will
either be conducted through the LEGEND Study or through a new project (the “Head Impact
and Trauma Surveillance Study, HITSS) that, if funded by a grant (to be submitted in June 2019
to the National Institutes of Health), would replace the current LEGEND Study, using mostly
identical measures as LEGEND, the Brain Health Registry, and the Notre Dame Former Players
Medical Research Project.
Summary
Millions of individuals play or have played tackle football and may be at increased risk for
later-life dementia and related disorders. However, the direct relationship between
exposure to repetitive head impacts from tackle football and long-term cognitive and
neuropsychiatric consequences is not well characterized. Results from this project will
expand the currently limited knowledge on the long-term cognitive and neuropsychiatric
consequences of tackle football, particularly at the college level. In so doing, this study
will advance research on the diagnosis, treatment, and prevention of the long-term
neurological consequences associated with exposure to repetitive head impacts,
including CTE. In addition, this study will be one of the first to address overall later-life
health status, including diagnosed medical conditions and substance use disorders, of
former college football players.
Project Timeline
Task |
Dates |
Finalize design with input from Association Steering Committee |
By August 29, 2018 |
Write, compile, and submit Institutional Review Board (IRB) proposal (including online consent forms); Reply to queries until approved |
June 18 – November 8, 2018 |
BU School of Public Health (SPH) Biostatistics and Epidemiology Data Analytics Center (BEDAC) modifies existing online- and interviewer-entered forms and create new forms specific for this study; Develop initial email distribution; Modify online data capture methods; Harmonize data capture and management systems with LEGEND Study; Create Study-Specific Landing Page (home page) |
June 18 – December 11, 2018 |
BU Study Staff conducts online and other searches to obtain contact information for all missing subjects (including next-of-kin for deceased) |
June 18 – December 11, 2018 |
Finalize email distribution methods and send first batch of emails to former players |
July 23 – July 28, 2018 |
Initiation of Health Survey – Part 1 |
December 12, 2018 |
Initiation of Part 2: Online Cognitive and Neuropsychiatric Testing and Interview Regarding Repetitive Head Impact Exposure History |
April 12, 2019 |
Anticipated completion of Part 1 data collection |
April 30, 2019 |
Analyze Part 1 data and prepare initial manuscript |
May 1, 2019 – June 30, 2019 |
Share Part 1 findings and draft manuscript with Association Steering Committee |
July 1, 2019 |
Revise Part 1 manuscript and submit to scientific journal (TBD) |
September 1, 2019 |
Anticipated completion of Part 2 data collection |
August 31, 2019 |
Analyze Part 2 data and prepare initial manuscript |
September 1, 2019 – October 30, 2019 |
Share Part 2 findings and draft manuscript with Association Steering Committee |
November 1, 2019 |
Revise Part 2 manuscript and submit to scientific journal (TBD) |
December 15, 2019 |
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Notre Dame Former Players Medical Research Project
Protocol Summary
February 1, 2019
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Notre Dame Former Players Medical Research Project
Protocol Summary
February 1, 2019
Page 11
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