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Study design:This is a review article.Objectives:This study discusses the following: (1) concepts and constraints for the determination of minimal clinically important difference (MCID), (2) the contrasts between MCID and minimal detectable difference (MDD), (3) MCID within the different domains of International Classification of Functioning, disability and health, (4) the roles of clinical investigators and clinical participants in defining MCID and (5) the implementation of MCID in acute versus chronic spinal cord injury (SCI) studies.Methods:The methods include narrative reviews of SCI outcomes, a 2-day meeting of the authors and statistical methods of analysis representing MDD.Results:The data from SCI study outcomes are dependent on many elements, including the following: the level and severity of SCI, the heterogeneity within each study cohort, the therapeutic target, the nature of the therapy, any confounding influences or comorbidities, the assessment times relative to the date of injury, the outcome measurement instrument and the clinical end-point threshold used to determine a treatment effect. Even if statistically significant differences can be established, this finding does not guarantee that the experimental therapeutic provides a person living with SCI an improved capacity for functional independence and/or an increased quality of life. The MDD statistical concept describes the smallest real change in the specified outcome, beyond measurement error, and it should not be confused with the minimum threshold for demonstrating a clinical benefit or MCID. Unfortunately, MCID and MDD are not uncomplicated estimations; nevertheless, any MCID should exceed the expected MDD plus any probable spontaneous recovery.Conclusion:Estimation of an MCID for SCI remains elusive. In the interim, if the target of a therapeutic is the injured spinal cord, it is most desirable that any improvement in neurological status be correlated with a functional (meaningful) benefit. [ABSTRACT FROM AUTHOR]

Study design:Two randomized, double-blind, placebo-controlled trials.Objective:To evaluate the efficacy and safety of fampridine sustained-release tablets (fampridine-SR) 25 mg twice daily for moderate-to-severe spasticity in patients with chronic spinal cord injury (SCI).Setting:United States and Canada.Methods:Patients with incomplete chronic SCI were randomized to twice daily fampridine-SR 25 mg or placebo, with a 2-week single-blind placebo run-in, a 2-week titration, 12 weeks of stable dosing, 2 weeks of downward titration and 2 weeks of untreated follow-up. Co-primary end points were the change from baseline, averaged over the double-blind treatment period, for Ashworth score (bilateral knee flexors and extensors) and a 7-point Subject Global Impression of treatment (SGI; 1, terrible; 7, delighted). Secondary end points were: Penn Spasm Frequency Scale; the motor/sensory score from the International Standards for Neurological Classification of SCI; Clinician's Global Impression of Change of neurological status; and the International Index of Erectile Function (men) or the Female Sexual Function Index (women).Results:The populations were 212 and 203 patients in the two studies, respectively. Changes from baseline in Ashworth score were −0.15 (placebo) and −0.19 (fampridine-SR) in the first study, and −0.16 (placebo) and −0.28 (fampridine-SR) in the second study. The between-treatment difference was not significant for either the Ashworth score or the SGI and, with few exceptions, neither were the secondary end points. Fampridine-SR was generally well tolerated; treatment-emergent adverse events (TEAEs) and serious TEAEs were reported with similar frequency between treatments.Conclusion:Fampridine-SR was well tolerated. No significant differences were observed between treatment groups for the primary end points of Ashworth score and SGI. [ABSTRACT FROM AUTHOR]

After three decades of clinical research on interventions to improve neurological outcomes in persons with spinal cord injury (SCI), the promise of preclinical discovery has yet to be translated into a consensus standard of care treatment. Nonetheless, SCI researchers remain hopeful that advances in preclinical discovery coupled with improved clinical trial performance will yield effective restorative treatment. This historical review of key studies in SCI over the past 30 years illustrates the progress that has been achieved in establishing a high standard in the conduct of clinical research while providing important lessons for improving trial design, conduct and reporting. Through application of these lessons, the performance of SCI trials can be improved, thereby shortening the pathway to successful translation and the development of effective therapies. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective, longitudinal analysis of sensory, motor and functional outcomes from individuals with thoracic (T2-T12) sensorimotor complete spinal cord injury (SCI)., Objectives: To characterize neurological changes over the first year after traumatic thoracic sensorimotor complete SCI., Methods: A dataset of 399 thoracic complete SCI subjects from the European Multi-center study about SCI (EMSCI) was examined for neurological level, sensory levels and sensory scores (pin-prick and light touch), lower extremity motor score (LEMS), ASIA Impairment Scale (AIS) grade, and Spinal Cord Independence Measure (SCIM) over the first year after SCI., Results: AIS grade conversions were limited. Sensory scores exhibited minimal mean change, but high variability in both rostral and caudal directions. Pin-prick and light touch sensory levels, as well as neurological level, exhibited minor changes (improvement or deterioration), but most subjects remained within one segment of their initial injury level after 1 year. Recovery of LEMS occurred predominantly in subjects with low thoracic SCI. The sensory zone of partial preservation (ZPP) had no prognostic value for subsequent recovery of sensory levels or LEMS. However, after mid or low thoracic SCI, ≥3 segments of sensory ZPP correlated with an increased likelihood for AIS grade conversion., Conclusion: The data suggest that a sustained deterioration of three or more thoracic sensory levels or loss of upper extremity motor function are rare events and may be useful for tracking the safety of a therapeutic intervention in early phase acute SCI clinical trials, if a significant proportion of study subjects exhibit such an ascent.

Study Design: Retrospective, longitudinal analysis of motor recovery data from individuals with cervical (C4-C7) sensorimotor complete spinal cord injury (SCI) according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)., Objectives: To analyze the extent and patterns of spontaneous motor recovery over the first year after traumatic cervical sensorimotor complete SCI., Methods: Datasets from the European multicenter study about SCI (EMSCI) and the Sygen randomized clinical trial were examined for conversion of American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade, change in upper extremity motor score (UEMS) or motor level, as well as relationships between these measures., Results: There were no overall differences between the EMSCI and Sygen datasets in motor recovery patterns. After 1 year, up to 70% of subjects spontaneously recovered at least one motor level, but only 30% recovered two or more motor levels, with lesser values at intermediate time points. AIS grade conversion did not significantly influence motor level changes. At 1 year, the average spontaneous improvement in bilateral UEMS was 10-11 motor points. There was only moderate relationship between a change in UEMS and a change in cervical motor level (r(2)=0.30, P<0.05). Regardless of initial cervical motor level, most individuals recover a similar number of motor points or motor levels., Conclusion: Careful tracking of cervical motor recovery outcomes may provide the necessary sensitivity and accuracy to reliably detect a subtle, but meaningful treatment effect after sensorimotor complete cervical SCI. The distribution of the UEMS change may be more important functionally than the total UEMS recovered.

Objective: To identify and quantify trends in mortality and causes of death among persons with spinal cord injury., Design: Cohort study., Setting: Model spinal cord injury care systems and Shriner's Hospitals spinal cord injury units throughout the United States., Patients: A total of 28,239 consecutive persons admitted to the model system or to a Shriner's Hospital within 1 year of injury., Main Outcome Measure: Length of survival and cause of death., Results: Among persons who were admitted to the model system within 1 day of injury, the odds of dying during the first postinjury year were reduced by 67% for persons injured between 1993 and 1998 relative to persons injured between 1973 and 1977 after adjusting for trends in age, gender, race, neurologic level of injury, Frankel grade, ventilator status, etiology of injury, sponsor of care, and model system where treatment occurred. However, mortality rates after the first anniversary of injury, which had also been declining from 1973 to 1992, increased 33% for persons injured between 1993 and 1998 relative to persons injured between 1988 and 1992. Respiratory disease was the only cause of death after the first anniversary of injury for which the relative odds increased meaningfully during the latest time period (76% increase over 1988-1992 compared to all other causes)., Conclusion: While great improvements in life expectancy have been achieved since the Model SCI Systems program began, current data support the need for renewed efforts to improve the prevention and treatment of the complications of spinal cord injury.

Posttraumatic syringomyelia as a cause of progressive neurologic deterioration has been well described. More recently, the noncystic posttraumatic tethered cord has been associated with identical progressive neurologic deterioration. A retrospective analysis of patients treated surgically with spinal cord untethering and/or cyst shunting to arrest a progressive myelopathy from a posttraumatic tethered and/or cystic cord was performed. Emphasis was on outcome using the American Spinal Injury Association (ASIA) sensory and motor scoring systems. During an 18-month period from May 1993 to December 1994, 70 patients with spinal cord injury were operated upon for tethered and/or cystic spinal cords because of a progressive myelopathy and deteriorating ASIA sensory/motor scores. Fifty-nine patients had follow-up data 1 year postoperatively. At the 1 year follow-up, there was small improvement in light touch sensory scores (0.67 points), pinprick scores (1.3 points), and motor scores (0.41 points) demonstrating that the progression of the myelopathic process was arrested. Thirty-four of these 59 patients had no previous surgery to their spinal cords. At 1 year follow-up, light touch scores improved on average 2.38 points, pinprick scores 3.88 points (p < 0.05), and motor scores 1.47 points, suggesting better outcome with first-time surgery. Of this latter group, 64.3% regained a lost function, 62.5% saw improvement in spasticity, 55.6% had substantial improvement in neurogenic pain, and 95.8% felt that surgery prevented further neurologic deterioration.

Lightning and electrical (L/E) injuries can be among the most dramatic of all events that damage the nervous system. The three major classes of neurologic sequelae that require the expertise of the neurorehabilitationist are: (1) cerebral disorders, either global or focal; (2) neuropsychologic sequelae; and (3) spinal cord injury. Neurorehabilitation management necessary for each of these three areas will be discussed. From the viewpoint of the neurorehabilitationist, therapy principles are the same for L/E trauma as for other more common forms of injury. The goal is to maximize the functional return given the specific impairment.

The announcement and publication of the second National Acute Spinal Cord Injury Study (NASCIS II) project's findings regarding the role of high dose methylprednisolone in improving neurological outcomes following acute traumatic spinal cord injury generated widespread excitement and interest. To determine the association between this interest and actual use and implementation of the protocol, Colorado's comprehensive population-based spinal cord injury surveillance data were examined. The medical records of 218 SCI survivors injured between May 1, 1990 and December 31, 1991, and of 145 persons spinal cord injured 2 years later, during 1993, were reviewed to determine the rapidity and extent of NASCIS II implementation by Colorado's hospitals, factors associated with use and non-use of the protocol, changing usage trends over time, and the short term neurological outcomes of patients who received the protocol. Clear documentation of the protocol's usage was present for only 46% of the reported patients' medical records in 1990-91, and 61% in 1993. Small, emergency triage facilities were significantly more likely to use the protocol than larger acute care hospitals, and patients with initially incomplete injuries were less likely to receive the drug. There were no significant differences in neurological outcomes, using the Frankel classification system, between those who received the protocol and those who did not. The limitations and implications of these findings are discussed.

This self-directed learning module highlights advances in this topic area. It is part of the chapter on rehabilitation in spinal cord disorders in the Self-Directed Medical Knowledge Program Study Guide for practitioners and trainees in physical medicine and rehabilitation. This article contains learning objectives on the anatomy of the spine and spinal cord, pathogenesis of spinal cord trauma, mechanisms of spinal fractures and dislocations, causes of nontraumatic spinal cord disorders, and research on neurologic recovery. Advances that are covered in this section include various experimental animal models for producing spinal cord injury and new approaches to limit damage in acute injury and to promote recovery in chronic injury.

This self-directed learning module highlights current concepts in outcomes and issues of aging in spinal cord injury. It is part of the chapter on rehabilitation in spinal cord disorders for the Self-Directed Medical Knowledge Program Study Guide for practitioners and trainees in physical medicine and rehabilitation. This article includes discussion of the measurement of impairment, disability, and handicap, and outcomes with respect to employment, long-term adjustment, aging, life expectancy, and causes of death in spinal cord injury.

This self-directed learning module highlights current concepts of the epidemiology, prevention, and systematic treatment of spinal cord disorders. It is part of the chapter on rehabilitation of spinal cord disorders for the Self-Directed Medical Knowledge Program Study Guide for practitioners and trainees in physical medicine and rehabilitation. This article contains information regarding the incidence, prevalence, and causes of spinal cord injury, methods of prevention, and the components of a comprehensive system of care for spinal cord injury.

This self-directed learning module highlights advances in the management of the person with a spinal cord deficit. Traumatic spinal cord injury is being used as the model, but the principles apply to all patients with spinal cord deficits. This article is part of the chapter on rehabilitation of spinal cord disorders for the Self-Directed Medical Knowledge Program Study Guide for practitioners and trainees in physical medicine and rehabilitation. Specifically, this section contains information regarding prehospital care, acute assessment and management, primary rehabilitation by systems, sexuality and psychosocial issues, management of pain and spasticity, functional goals, the role of functional electrical stimulation, and long-term follow-up.