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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.
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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
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
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
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
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.
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
Source: Annual Report (2007) for the Spinal Cord Injury Model SystemsNational Spinal Cord Injury Statistical CenterBirmingham, AL SCI Descriptive Data Summary, 1973 - 2007
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
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
SCI Epidemiology • Severity of injury • Complete 49% • Sensory incomplete 10.3% • Motor incomplete (weak) 11.2% • Motor incomplete 29.1% • “Normal” function 0.8%
SCI Epidemiology • Neurologic level of injury (LOI) • Incomplete tetraplegia 34.1% • Complete paraplegia 23.0% • Complete tetraplegia 18.3% • Incomplete paraplegia 18.5% • Full neurologic recovery <1%
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
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
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
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
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
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
Central Cord Syndrome • Seen in older persons, hyperextension injury secondary to a fall • Greater motor and sensory impairmentof the hands and arms than the legs • Variable bowel and bladder impairment
Brown-Sequard Syndrome • Hemisection of cord • Usually due to penetrating injury • Ipsilateral loss of motor function, proprioception, and vibration • Contralateral loss pain and temperature
Cauda Equina Syndrome • Peripheral nerve injury • Variable loss in motor and sensory function of lower extremities
Contemporary issues in sci care: The Health care system, rehabilitation & aging issues
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
Secondary Conditions • Neurologic system • Late neurologic deterioration • Musculoskeletal system • Overuse syndromes • Genitourinary system • Bladder – infections, stones, cancer • Kidney – infections, stones, other • Gastrointestinal system
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
Secondary Conditions • Metabolic • Altered body composition • Carbohydrate and lipid disorders • Bone • Universal osteoporosis • Psychosocial • Adjustment to disability, depression, fatigue • Participation • Substance abuse
Rehabilitation research for improved health and recovery after spinal cord injury
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
Challenges of Translational Research • Lack of refined outcome measures • ASIA motor and sensory exam • Ashworth • Functional Independence Measure (FIM)
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
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
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
Emerging Outcome Measures • ASIA sub-scores • Electrophysiologic testing • QST • SCIM III
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
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
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
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
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&B 18% Trunk stability 16.5% Walking 15.9% Chronic pain 12% Sensation 7.5% Arm/hand 3.3% Consumers Preferences Anderson, 2004
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)
References • Online Syllabus and Data Collection Forms • (http://www.spinalcord.uab.edu/show.asp?durki=24480) • Facts & Figures at a Glance • http://www.spinalcord.uab.edu/show.asp?durki=116979 • Mid-year and Annual Statistical Reports • http://www.spinalcord.uab.edu/show.asp?durki=116891