1. Demystifying Spinal Cord Injury Suzanne L. Groah, MD, MSPH Director of Spinal Cord Injury Research Director of the National Capital Spinal Cord Injury Model System National Rehabilitation Hospital, Washington, DC

2. NEW LOGO Funded by: the National Institute on Disability and Rehabilitation Research (NIDRR), Office of Special Education Services, U.S. Department of Education Washington, D.C. Grant # H133N060028

3. NEW LOGO Definition of Spinal Cord Injury  Any injury to the spinal cord via blunt or penetrating trauma  Contrast with spinal cord disease  Manifests as variable loss of neurological function below the injury site: Motor and sensory impairment Autonomic, bowel, bladder and sexual dysfunction  Catastrophic injury with long-term medical and psychosocial consequences

4. NEW LOGO Spinal Cord Injury Model Systems  The Spinal Cord Injury Model Systems (SCIMS) program was established by the Rehabilitation Services Administration in the early 1970s  The SCIMS are specialized programs of care in SCI which gather information and conduct research with the goal of improving long-term functional, vocational, cognitive, and quality-of-life outcomes for individuals with SCI Lammertse, Jackson and Sipski, 2004; NIDRR

5. NEW LOGO Spinal Cord Injury Model Systems  Model System grantees contribute data to a national statistical center that tracks the long-term consequences of SCI and conduct research in the areas of medical rehabilitation, health and wellness, service delivery, short- and long-term interventions, and systems research.  Each Model System also is charged with disseminating information and research findings to patients, family members, health-care providers, educators, policymakers and the general public.

6. NEW LOGO Current SCI Model Systems

7. NEW LOGO National SCIMS Database  Captures approximately 13% of all new SCI occurring in the U.S.  Established at the University of Alabama at Birmingham in 1983  Coordinates data collected by all SCI Model Systems Centers Registry – 10,357 participants Form I – 25,415 participants Form II – 115,448 participants, up to 30 years post injury

8. NEW LOGO SCI DESCRIPTIVE DATA SUMMARY, 1973 - 2007 Source: Annual Report (2007) for the Spinal Cord Injury Model Systems National Spinal Cord Injury Statistical Center Birmingham, AL

9. NEW LOGO SCI Epidemiology  Incidence* 40/million 12,000 new cases per year Does not include those who die at scene  4/million or 1,000 per year  Prevalence* 255,702 (range 227,080 – 300,938) *Data estimated from several studies

10. NEW LOGO SCI Epidemiology  Age at injury Mean 39.5 years (since 2005) More people 60 years+ at time of injury  77% male  Etiology 42% MVC, 27% falls, 15% violence, 7% sports MVC #1 cause if <45 years Falls #1 cause if >45 years

11. NEW LOGO Age at Injury

12. NEW LOGO Education

13. NEW LOGO Marital Status

14. NEW LOGO Occupational Status

15. NEW LOGO Race

16. NEW LOGO SCI Epidemiology  Severity of injury Complete49% Sensory incomplete10.3% Motor incomplete (weak)11.2% Motor incomplete29.1% “Normal” function0.8%

17. NEW LOGO SCI Epidemiology  Neurologic level of injury (LOI) Incomplete tetraplegia34.1% Complete paraplegia23.0% Complete tetraplegia18.3% Incomplete paraplegia18.5% Full neurologic recovery<1%

18. NEW LOGO Spinal Cord Injury Mortality  6.3% die in first year  Mortality associated with Older age Male Violence C4 or higher injury level Vent dependent status Neurologically complete injury Medicare/Medicaid

19. NEW LOGO Life Expectancy Individuals Surviving 1 Year Post-SCI Age at SCI No SCIMotor Fxl Any Level ParaLow TetraHigh Tetra Vent 2058.453.045.841.037.423.8 4039.534.528.224.221.211.4 6022.218.013.210.48.63.2

20. NEW LOGO CLASSIFICATION OF INJURY AND PROGNOSIS FOR RECOVERY

21. NEW LOGO Classification of Spinal Cord Injury  Level of injury (LOI) Motor, sensory, and sacral examinations  Severity of injury Complete (ASIA A) Incomplete (ASIA B, C, D, E)  Incomplete syndromes Anterior Cord Syndrome Central Cord Syndrome Brown-Sequard Syndrome Cauda Equina Syndrome

22. NEW LOGO ASIA Impairment Scale

23. NEW LOGO Prognosis for Recovery  Neurologic assessment at 72h – 1 week superior to earlier testing  Repeat testing within 72 h – 1 week window  Sensory exam better for predicting motor recovery in LE than UE

24. NEW LOGO Prognosis for Recovery  50-67% of total 1-year recovery occurs in first 2 months  Slower recovery during 3-6 mos  Motor recovery documented up to 2 yrs

25. NEW LOGO Recovery by ASIA Impairment Grade  Proportion of subjects exhibiting spontaneous AIS grade conversion 75-80% AIS A remain A 35-40% AIS B convert to C or D 60-80% AIS C convert to D Nearly all AIS D remain D

26. NEW LOGO Anterior Cord Syndrome  Compression of the anterior spinal artery, bony fragments or herniated disc  Loss/decreased strength bilaterally  Incomplete sensory loss  Loss/decreased pain and temperature  Preserved vibration sense

27. NEW LOGO Central Cord Syndrome  Seen in older persons, hyperextension injury secondary to a fall  Greater motor and sensory impairment of the hands and arms than the legs  Variable bowel and bladder impairment

28. NEW LOGO Brown-Sequard Syndrome  Hemisection of cord  Usually due to penetrating injury  Ipsilateral loss of motor function, proprioception, and vibration  Contralateral loss pain and temperature

29. NEW LOGO Cauda Equina Syndrome  Peripheral nerve injury  Variable loss in motor and sensory function of lower extremities

30. NEW LOGO CONTEMPORARY ISSUES IN SCI CARE: THE HEALTH CARE SYSTEM, REHABILITATION & AGING ISSUES

31. NEW LOGO Changes to the System of Care  Financial resources declining for trauma and emergency care  More patients are arriving at acute rehabilitation with significant secondary conditions  Fewer ventilator-capable rehabilitation centers  Acute rehabilitation length of stay declining Rehospitalizations increasing People leaving rehabilitation less prepared to care for themselves and often without proper equipment

32. NEW LOGO Secondary Conditions  Neurologic system Late neurologic deterioration  Musculoskeletal system Overuse syndromes  Genitourinary system Bladder – infections, stones, cancer Kidney – infections, stones, other  Gastrointestinal system

33. NEW LOGO Secondary Conditions  Integument Skin breakdown  Pulmonary system Pneumonia, impaired cough, other  Cardiovascular system Autonomic imbalance, low/high blood pressure Risk for early cardiovascular disease  Sexuality/Fertility

34. NEW LOGO Secondary Conditions  Metabolic Altered body composition Carbohydrate and lipid disorders  Bone Universal osteoporosis  Psychosocial Adjustment to disability, depression, fatigue Participation Substance abuse

35. NEW LOGO REHABILITATION RESEARCH FOR IMPROVED HEALTH AND RECOVERY AFTER SPINAL CORD INJURY

36. NEW LOGO Emerging Rehabilitative Research  Once solely focused on prevention of secondary conditions  Now, with increasing numbers of clinical trials Body-weight supported ambulation Neuromuscular electrical stimulation Functional electrical stimulation Activity-based rehabilitation Therapies for neurorecovery and restoration

37. NEW LOGO Challenges of Translational Research  Lack of refined outcome measures ASIA motor and sensory exam Ashworth Functional Independence Measure (FIM)

38. NEW LOGO Problems With Outcome Measures  Using AIS  Ex: 2 grade changes in AIS (A to C) as in Sygen trial  Baseline: C5 AIS A with UEMS=15  Recovery: After treatment UEMS=42 Functional paraplegic  Outcome: Subject still AIS A and according to trial did not respond to treatment

39. NEW LOGO Problems With Outcome Measures  Using AIS  Ex: Using 10 point improvement of motor  Baseline: C4 AIS A  Recovery: After treatment subject acquires sensation/motor at S4-S5 and some muscles have non-functional improvement (UEMS=14, LEMS=10); No functional change  Outcome: Subject had 20 point motor improvement and is considered a success but little functional change

40. NEW LOGO Functional Independence Measure  A measure of disability (functional limitation), burden of care, performance  18 items in 6 categories (self care, sphincter control, mobility, locomotion, communication, social cognition)  SCI – inter-rater.83 for total score, individual items.42  Recommended by ASIA in 1992, dropped in 2000  Significant floor and ceiling effects for patients with SCI This is our second most common tool, Not all aspects relevant to SCI

41. NEW LOGO FIM by ASIA Change – A to C

42. NEW LOGO Emerging Outcome Measures  ASIA sub-scores  Electrophysiologic testing  QST  SCIM III

43. NEW LOGO Power Issues  Number of enrolled subjects necessary to show a statistical difference between experimental and control groups using modest change in AIS motor score Approx 60 AIS A tetra subjects to show 10 point difference Approx 200 AIS A tetra subjects to show 5 point difference Number of participants may increase 4X when incomplete subjects enrolled

44. NEW LOGO Timing of Intervention  Most functional change occurs within 3 months of injury and plateaus after 1 year  Thus, number of subjects needed decreases with delayed treatment  Highest probability for detecting clinical benefit is during chronic SCI  However, this is potentially most difficult time biologically to influence the cord

45. NEW LOGO Clinical Targets  Many pharmacologic and cell-based therapeutics are applied near the site of injury Consider how to track segmental improvement  Spontaneous functional improvement of one spinal level is common  Spontaneous improvement of 2 spinal levels less common (5-20%) in AIS A tetraplegics

46. NEW LOGO Translational Research  Public pressure Lack of knowledge about scientific evidence development Impatience with slow methodical pace of science  Impact of quasi-scientific case series masquerading as research

47. NEW LOGO Anderson, 2004 Consumers Preferences Tetraplegia:  Arm/hand 48.7%  Sexual 13%  Trunk stability 11.5%  B&B 8.9%  Walking 7.8%  Sensation 6.1%  Chronic pain 4% Paraplegia:  Sexual 26.7%  B&B18%  Trunk stability16.5%  Walking 15.9%  Chronic pain12%  Sensation7.5%  Arm/hand 3.3%

48. NEW LOGO References  Lammertse DP, Jackson AB, Sipski ML. Research from the model spinal cord injury systems: Findings from the current 5-year grant cycle. Arch Phys Med Rehabil. 2004;85(11):1737-1739.  National Institute on Disability and Rehabilitation Research - Disability and Rehabilitation Research Projects and Centers Program - Spinal Cord Injury Model Systems Centers and Disability Rehabilitation Projects. Federal Register. Vol 70.238; December 13, 2005:73738-73741.  Compilation of database research contributed by SCIMS investigators Books (1986, 1990, 1995) and special issues of Archives of Physical Medicine and Rehabilitation (1999, 2004)

49. NEW LOGO References  Online Syllabus and Data Collection Forms (http://www.spinalcord.uab.edu/show.asp?durki=24480)http://www.spinalcord.uab.edu/show.asp?durki=24480  Facts & Figures at a Glance  http://www.spinalcord.uab.edu/show.asp?durki=116979 http://www.spinalcord.uab.edu/show.asp?durki=116979  Mid-year and Annual Statistical Reports  http://www.spinalcord.uab.edu/show.asp?durki=116891 http://www.spinalcord.uab.edu/show.asp?durki=116891

50. NEW LOGO ASIA

51. NEW LOGO Paralyzed Veterans of America

52. NEW LOGO Spinal Cord Injury Rehabilitation Evidence

53. NEW LOGO THANK YOU For more information, email Suzanne.L.Groah@Medstar.Net