Presentation for The American Academy of Physical Medicine and Rehabilitation Annual Congress

Pseudobulbar Affect Symptoms, Prevalence and Impact in Former Professional Football Players: Results of an Online Survey

Co-Authors:

Jay H. Rosenberg, MD, The Neurology Center

Amy Kincaid, Avanir Pharmaceuticals, Inc.

Charles Yonan, PharmD, Avanir Pharmaceuticals, Inc.

Shereen McIntyre, MBA, Avanir Pharmaceuticals, Inc.

Andrea Formella, PharmD, BCPP, Avanir Pharmaceuticals, Inc.

Gregory O’Shanick, MDCenter for Neurorehabilitation Services, Richmond, VA Medical Director Emeritus, BIAA

DISCLOSURE

I have relevant financial relationships with the products or services described, reviewed, evaluated, or compared in the presentation

Avanir Pharmaceuticals, Inc. – Consultant

► This survey was conducted through The Gridiron Greats Assistance Fund in conjunction with Avanir Pharmaceuticals, Inc., who provided funding for this survey, and GfK Custom Research, LLC who hosted the online survey and collated the survey data

2

Objective:

Investigate the prevalence and impact of pseudobulbar affect (PBA) symptoms as a potential consequence of sports-related head injuries among former professional football players

Pseudobulbar Affect (PBA):

Occurs secondary to certain neurologic diseases or brain injuries

Characterized by sudden, uncontrollable, laughing and/or crying episodes that are exaggerated to situation/social context and excessive or unrelated to mood

3

OBJECTIVE & BACKGROUND

Design:

Survey conducted through the Gridiron Greats Assistance Fund

~ 15-minute online survey sent to Gridiron Greats email list Nov-Dec 2014

Eligible participants were ≥18 years of age, and:

• A former professional football player; or

• A family member, person living with or caring for a former player

Survey questions included:

• Basic Demographics

• History of head injury or concussion

• Center for Neurologic Study–Lability Scale (CNS-LS), a 7-item PBA self-assessment measure previously validated in ALS and MS populations 1-2

• PBA symptom (excessive, uncontrollable laughing or crying) frequency and impact on activities and relationships

• Interactions with Medical Professionals regarding PBA symptoms 41. Moore SR, et al. J Neurol Neurosurg Psychiatry. 1997;63(1):89-93; 2. Smith RA, et al. Mult Scler 2004;10:1-7.

STUDY METHODOLOGY

Gridiron Greats was founded by Jerry Kramer in 2007

The mission is to provide support to retired football players and their families with hardships they face after their football careers such as:

Medical and dental services

Medication

Transportation costs for medical evaluations and surgeries

Housing and costs of utilities

Coordination of services for food and other daily necessities

5http://gridirongreats.org/mission/

GRIDIRON GREATS ASSISTANCE FUND

1There are times when I feel fine 1 minute, and then I’ll become tearful the next over something small or for no reason at all

2Others have told me that I seem to become amused very easily or that I seem to become amused about things that really aren’t funny

3 I find myself crying very easily

4 I find that even when I try to control my laughter, I am often unable to do so

5There are times when I won’t be thinking of anything happy for funny at all, but then I’ll suddenly be overcome by funny or happy thoughts

6 I find that even when I try to control my crying, I am often unable to do so

7 I find that I am easily overcome by laughter

For purposes of the survey, the presence of PBA symptoms was defined as either: a CNS-LS ≥ 13, or if <13 answering “yes” to the following question:

“Have you (has the player) experienced sudden, involuntary episodes of crying and/or laughing that were exaggerated or even contrary to how you (he) felt at the time”

1. Moore, SR, et al. J Neurol Neurosurg Psychiatry. 1997;63(1):89-93; 2. Smith RA, et al. Mult Scler 2004;10:1-7.

Center for Neurologic Study - Lability Scale (CNS-LS)

1: Never 2: Rarely 3: Occasionally 4: Frequently 5: Most of the time

Describe the degree to which each item applies to you DURING THE PAST WEEK

ASSESSMENT OF PBA SYMPTOMS

Sample demographics: 516 total respondents

474 former professional football players + 42 family caregivers

All former players were male

Median player age was 56 - 65 years

Most players were married (76%)

Race: 65% White, 31% Black/African American

Education: 85% had a bachelor’s degree or higher; all but 1 player had attended at least some college

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23 (3%)did not qualify

231 (30%)terminated

early

Approximately 7000 surveys

sent

770 clicked on the survey

516 (67%) completed the survey

DEMOGRAPHICS

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99% of former players had experienced some form of head injury during their football career:

73% (N=378) had “suffered from a head injury, concussion, or TBI”

Among those who did not report head injury on initial question (n=138); all but 3 reported experiencing some form of blow to the head

Most reported multiple head injuries; 60% reporting more than 5; 16% reporting more than 21

'Had [your/their] bell rung'

Taken a hit to the head and felt dizzy or wobbly after

Taken a hit to the head, but experienced no side effects

Taken a hit to the head and had a headache immediately after, or within the next few days

Taken a hit to the head and experienced temporary memory loss (either immediately or within a few days)

None of these

0% 50% 100%

75%

70%

44%

35%

28%

2%

Former players who did not identify as having a head injury (n=138) were asked: “During your/their football career, have you/have they

ever..?”

Head In-jury, Con-cussion or

TBI73%

No27%

Head injury was defined as, “skull fracture, being knocked unconscious, having a head injury requiring hospitalization, feeling wobbly or disoriented after taking a hit to the head, or experiencing temporary memory loss after being hit.”

Have you personally suffered/has the person you live with who played professional football suffered from a head injury, concussion or TBI?

PREVALENCE OF HEAD INJURY

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Q: Due to your (the football players’) head injury(s), have you (they) ever personally experienced the following?

0

10

20

30

40

50

60

70

80

62

5552

37 35

12

4

25

1719

Resp

on

den

ts,

%

41% reported emotional lability (n=209)

13% reported laughing and/or crying (n=66)

EXPERIENCE OF SYMPTOMS ATTRIBUTABLE TO HEAD INJURY (N=513)

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48% of former football players with a head injury (N=513) self-classified these injuries collectively as moderate or severe

Concern for future head injury-related complications increased with reported severity

Mild52%

Moderate 42%

Severe6%

Severe: Was hospitalized and/or diagnosed with a severe brain injury and/or experienced many long lasting effects.

Moderate: Lost consciousness and/or diagnosed with a concussion/fracture and/or experienced some long lasting effects.

Mild: Experienced temporary dizziness and/or other short term symptoms, but no real long lasting effects.

Reported Severity of Head Injury:

Thinking of all the head injuries you have/the football player has suffered collectively, how would you classify the severity?

HEAD INJURY SEVERITY

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► Overall, 33% (168/516) of respondents had PBA symptoms; including:

31% (n=158) with a CNS-LS score ≥13; and 2% (n=10) with CNS-LS <13 who answered “yes” to the follow-on question about involuntary/excessive laughing or crying

8% (41/516) had CNS-LS ≥21, suggesting moderate to severe PBA symptoms

► The 168 with PBA symptoms were asked about episode frequency:

Few Times a Year Few Times a Month At Least Once a Week

At Least Once a Day0%

50%

42%

27%

20%

10%

Pe

rce

nta

ge

of

Re

spo

nd

en

ts

How frequently do you (the player) experience these episodes of sudden, uncontrollable crying or laughing?

30% experienced crying or laughing episodes at least weekly

Laughing/crying episode frequency correlated with increased CNS-LS score (Pearson correlation, 0.424; P<.0001)

PBA SYMPTOM PREVALENCE & FREQUENCY

“How often do these sudden, uncontrollable crying or laughing episodes interfere with ability to do any of the following?”

PBA SYMPTOMS INTERFERED WITH ACTIVITIES AND RELATIONSHIPS (N=168)

Spend time with friends and familyMaintain a marriage or significant

relationshipWork

Participate in social activities

Talk on the telephone

Make and keep friends

Go to the moviesAttending or participating in a sporting

eventParticipate in group community activities

Shop

Drive a car

Dine out

Interact with healthcare professionals

Participate in rehabilitation therapy

VolunteerAttend church/synagogue/house of

worshipLive independently

13%

13%

9%

8%

11%

11%

9%

7%

8%

3%

7%

5%

4%

5%

8%

9%

7%

30%

25%

24%

26%

21%

19%

20%

23%

20%

10%

20%

19%

20%

12%

19%

18%

12%

43%

38%

33%

34%

32%

30%

29%

30%

28%

13%

27%

24%

24%

17%

27%

27%

19%

► Increasing PBA symptoms (CNS-LS) were correlated with greater interference

Very Often Sometimes

► Sudden uncontrollable crying/laughing episodes were associated with feelings of depression, isolation, loneliness, and embarrassment; the frequency of experiencing each of these negative emotions showed significant correlation with CNS-LS score

Psychological Impact of Uncontrollable Crying or Laughing Episodes in Respondents with PBA Symptoms (N=168)

Possible responses were “most of the time”, “frequently”, “occasionally” or “rarely”. Responses of “rarely” or “occasionally” are not shown.

Depressed

Isolated

Alone

Embarrassed

A little bit crazy

Like a burden to others

Scared

Out of control

29%

20%

20%

20%

19%

19%

16%

13%

21%

19%

18%

16%

13%

11%

12%

11%

50%

39%

38%

36%

32%

30%

28%

24%

Frequently Most of the Time Series3

*Pearson correlation of CNS-LS score and frequency response for each item; P < .0001

Possible responses were “most of the time”, “frequently”, “occasionally” or “rarely”. Responses of “rarely” or “occasionally” are not shown.

0.36*

0.34*

0.40*

0.34*

0.40*

0.50*

0.42*

0.46*

Pearson correlation coefficients

PSYCHOLOGICAL IMPACT OF PBA SYMPTOMS

Don’t feel the symptoms are serious

enough

Thought it was just depression

Too embarrassed to mention

Believed it was just a symptom or part of

the head injury

Don’t feel the doctor can offer any answers

Other

43%

29%

25%

25%

24%

14%

Reasons for Not Discussing (N=123)

Have you discussed uncontrollable laughing/crying episodes with a healthcare

professional?(N=168)

► 73% (123/168) of those with PBA symptoms had not discussed laughing or crying episodes with a healthcare provider (HCP)

► Of the 16% (n=27) who discussed PBA symptoms with a HCP

14 received any diagnosis for the symptoms; most commonly depression, bipolar disorder or other mood disorder (n=6)

None were diagnosed with PBA (or related term) as a result of these discussions

PBA SYMPTOMS WERE OFTEN NOT REPORTED TO HEALTHCARE PROVIDERS

0%

10%

20%

30%

40%

50%

60%

70%

80%73%

16%11%

NO YES I DON’T KNOW

CONCLUSION

Most (99%) former professional football players responding to this Gridiron Greats Assistance Fund survey (N=516) reported some form of head injury during their playing career

33% (n=168) reported symptoms suggestive of PBA (either CNS-LS ≥13 or CNS-LS <13 with presence of sudden, uncontrolled, excessive or inappropriate crying or laughing)

Higher CNS-LS scores were associated with greater laughing crying episode frequency, greater psychological impact of episodes and greater interference with activities and relationships

Few players discussed laughing/crying episodes with a medical professional; when they did it did not result in a PBA diagnosis

Survey results demonstrate the need for greater awareness, screening and detection of PBA among former professional athletes; proper diagnosis may impact treatment decisions

THANK YOU

I would like to acknowledge and thank the Gridiron Greats Assistance Fund and the athletes and caregivers who participated in this survey.