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Study design:Prospective, observational cohort study.Objectives:This paper describes the rationale and methodology for the Study of Health and Activity in People with Spinal Cord Injury (SHAPE SCI). The study aims to (1) describe physical activity levels of people with different injury levels and completeness, (2) examine the relationship between physical activity, risk and/or presence of secondary health complications and risk of chronic disease, and (3) identify determinants of physical activity in the SCI population.Setting:Ontario, Canada.Methods:Seven hundred and twenty men and women who have incurred a traumatic SCI complete self-report measures of physical activity, physical activity determinants, secondary health problems and subjective well-being during a telephone interview. A representative subsample (n=81) participate in chronic disease risk factor testing for obesity, insulin resistance and coronary heart disease. Measures are taken at baseline, 6 and 18 months.Conclusion:SHAPE SCI will provide much-needed epidemiological information on physical activity patterns, determinants and health in people with SCI. This information will provide a foundation for the establishment of evidence-based physical activity guidelines and interventions tailored to the SCI community.Spinal Cord (2008) 46, 216-221; doi:10.1038/sj.sc.3102103; published online 24 July 2007. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this randomized pilot was to determine feasibility of testing Reiki, a complementary therapy intervention, for women undergoing breast biopsy (BB). Background: Increasingly women face the possibility of BB, the definitive test for breast cancer. Psychological distress associated with BB includes anxiety and depression. Reiki was proposed as an intervention to decrease anxiety and promote relaxation. Method: Thirty-two women scheduled for BB were randomized to Reiki intervention versus conventional care control. Anxiety and depression were evaluated using self-report questionnaires. Findings: Analysis found no significant mean differences between groups over time. Comparably low baseline anxiety levels (possible selection bias) decreased naturally with time allowing little room for observing treatment effect. Conclusions: Reiki, when administered in the naturalistic setting of a complementary therapy office, did not suggest evidence of efficacy. An intervention offered within the bounds of the conventional care setting may be more feasible for addressing BB distress. [ABSTRACT FROM AUTHOR]

Plasma concentration profiles of the K+ channel-blocking compound Fampridine were obtained from (1) control subjects (n = 6) following oral administration of doses of 10, 15, 20, and 25 mg and (2) patients with spinal cord injury (SCI) (n = 11) following a single oral dose of 10 mg of an immediate-release formulation. Plasma concentrations were determined using a reversed-phase ion-pair high-performance liquid chromatography (HPLC) assay with ultraviolet light detection employing liquid extraction. The drug was rapidly absorbed with a tmax approximately 1 hour for both groups; tmax was independent of dose. Cmax and AUC0-infinity were linearly related to dose, and t 1/2 was 3 to 4 hours for both groups. There were no obvious differences in the (10-mg) plasma concentration profiles between control subjects and SCI patients. The drug was well tolerated, with only mild and transient side effects of light-headedness, dysesthesias, and dizziness. [ABSTRACT FROM AUTHOR]

Eighty persons with first-time, nontraumatic amputation, mean age 66.7 yrs +/-12.6 (1 SD) were examined to determine the extent of peripheral neuropathy (PN) present in the intact limb. Thirty-eight (47.5%) of the subjects had confirmed diabetes mellitus (DM); in those subjects, vibration sense (73.3%), temperature sense (42.1%), and nociception (71.1%) were decreased or absent in the intact limb. The prevalence of sensory impairment was significantly less in nondiabetic subjects in whom vibration sense 46.5% (p<0.02), temperature sense 16.3% (p<0.01), and nociception 32.6% (p<0.02) were decreased or absent. Using a scale that stages the severity of PN, a significant difference (p<0.001) in the distribution was found between these two groups. Only one person with known DM had no evidence of PN. Twenty-eight out of 42 nondiabetic subjects had evidence of PN. Eighty percent of all subjects had PN. This study confirms the significant potential for PN in persons with DM and presents new evidence of a significant incidence of neuropathy in nondiabetic individuals with amputation. The finding of unexpected peripheral nerve compromise is an important consideration in the treatment of persons with peripheral vascular disease who are at risk for amputation and for persons with amputation who depend on the intact limb for stability and ambulation. [ABSTRACT FROM AUTHOR]

ABSTRACTA community-based program is increasingly recognized as promoting health and active social participation in one's life, yet information is lacking about the use and impact of such programs among immigrant visible minority seniors. This mixed-method research evaluated the impact of a cultural community program for Korean immigrant seniors by examining participants' health-related quality of life (HR-QOL) benefits and overall well-being. In this study, 79 participants completed the SF-36v2 questionnaire twice to assess the impact of Canada Enoch Senior's College (CESC) program on their HR-QOL and well-being. Statistically significant improvement in physical and mental health domains was observed: bodily pain and role limitations due to emotional problems. Qualitative data from participants' interviews supported the survey findings with positive contributions in health and social arenas of seniors' lives. These results suggest that the CESC program contributes to quality of life and well-being of Korean senior participants and supports similar community-based cultural programs.

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.

Advanced practitioners in oncology want patients to receive state-of-the-art care and support for their healing process. Evidence-informed practice (EIP), an approach to evaluating evidence for clinical practice, considers the varieties of evidence in the context of patient preference and condition as well as practitioner knowledge and experience. This article offers an EIP approach to energy therapies, namely, Therapeutic Touch (TT), Healing Touch (HT), and Reiki, as supportive interventions in cancer care; a description of the author's professional experience with TT, HT, and Reiki in practice and research; an overview of the three energy healing modalities; a review of nine clinical studies related to oncology; and recommendations for EIP. These studies demonstrate a response to previous research design critiques. Findings indicate a positive benefit for oncology patients in the realms of pain, quality of life, fatigue, health function, and mood. Directionality of healing in immune response and cell line studies affirms the usual explanation that these therapies bring harmony and balance to the system in the direction of health. Foremost, the research literature demonstrates the safety of these therapies. In order to consider the varieties of evidence for TT, HT, and Reiki, EIP requires a qualitative examination of patient experiences with these modalities, exploration of where these modalities have been integrated into cancer care and how the practice works in the oncology setting, and discovery of the impact of implementation on provider practice and self-care. Next steps toward EIP require fleshing out the experience of these modalities by patients and health-care providers in the oncology care setting.

This study examined whether levels of chronic disease risk factors change over time, and whether leisure-time physical activity (LTPA) can explain any of the variation in those risk factors that change, in a sample of community-dwelling people living with spinal cord injury (SCI) in or near Hamilton, Ontario, Canada. LTPA was measured using the Physical Activity Recall Assessment for People with SCI at baseline (n = 76 adults with chronic (≥1 year) paraplegia or tetraplegia), at 6 months (n = 71) and at 18 months (n = 63). Body mass index, waist circumference at the lowest rib (WC(lowest rib)) and iliac crest (WC(iliac crest)), fat mass, blood pressure, and biochemical data were collected at all 3 time points. Women's BMI was higher at baseline (least square means (LSM) = 26.2 ± SE = 1.56 kg·m(-2), p = 0.0004) and 6 months (25.9 ± 1.6, p = 0.0024) than at 18 months (22.1 ± 1.72). Men's WC(lowest rib) increased from baseline (92.1 ± 1.87 cm) to 18 months (93.6 ± 1.87, p = 0.0253). Women who were active vs. inactive at baseline had a lower BMI at 6 months (23.1 ± 2.91 vs. 29.7 ± 2.52, p = 0.0957) and WC(iliac crest) at 6 months (82.8 ± 6.59 vs. 97.7 ± 5.10, p = 0.0818). Women who were active vs. inactive at 6 months had a lower WC(iliac crest) at 18 months (73.4 ± 14.3 vs. 102.5 ± 6.41, p = 0.0723). There was little change in traditional risk factors over 18 months. Future studies should extend beyond 18 months in a larger sample, and explore traditional vs. novel risk factors and onset of cardiovascular disease and diabetes in the SCI population.

Background: Most studies of physical activity predictors in people with disability have lacked a guiding theoretical framework. Identifying theory-based predictors is important for developing activity-enhancing strategies., Purpose: To use the World Health Organization's International Classification of Functioning, Disability and Health (ICF) framework to identify predictors of leisure time physical activity among people with spinal cord injury (SCI)., Methods: Six hundred ninety-five persons with SCI (M age=47; 76% male) completed measures of Body Functions and Structures, Activities and Participation, Personal Factors, and Environmental Factors at baseline and 6-months. Activity was measured at 6 and 18 months. Logistic and linear regression models were computed to prospectively examine predictors of activity status and activity minutes per day., Results: Models explained 19%-25% of variance in leisure time physical activity. Activities and Participation and Personal Factors were the strongest, most consistent predictors., Conclusions: The ICF framework shows promise for identifying and conceptualizing predictors of leisure time physical activity in persons with disability.

Objective: To describe the types, intensities, and average duration of leisure time physical activities (LTPAs) performed by people with chronic spinal cord injury (SCI)., Design: Cross-sectional telephone survey., Setting: General community., Participants: Men and women with SCI (N=347) who reported engaging in LTPA over the previous 3 days., Interventions: Not applicable., Main Outcome Measures: Mean minutes a day of LTPA performed at mild, moderate, and heavy intensities; proportion of respondents performing specific types of LTPA., Results: Participants reported a mean +/- SD of 55.15+/-59.05min/d of LTPA at a mild intensity or greater. Median LTPA was 33.33min/d. More activity was done at a moderate intensity (mean +/- SD, 25.49+/-42.11min/d) than mild (mean +/- SD, 19.14+/-37.77min/d) or heavy intensities (mean +/- SD, 10.52+/-22.17min/d). Most participants reported mild (54%) or moderate intensity LTPA (68%), while a minority reported heavy intensity LTPA (43%). The 3 most frequently reported types of LTPA were resistance training (33%), aerobic exercise (25%), and wheeling (24%). Craftsmanship (mean +/- SD, 83.79+/-96.00min/d) and sports activities (mean +/- SD, 60.86+/-59.76 min/d) were performed for the longest durations., Conclusions: There is considerable variability in daily LTPA among active people with SCI and variability across different types of LTPA in terms of typical durations and intensities. This information can be used to help people with chronic SCI become more active by highlighting activities that meet individual abilities, needs, and desires.

Objective: To investigate whether electric stimulation therapy (EST) administered as part of a community-based, interdisciplinary wound care program accelerates healing of pressure ulcers in people with spinal cord injury (SCI)., Design: Single-blind, parallel-group, randomized, controlled, clinical trial., Setting: Community-based home care setting, Ontario, Canada., Participants: Adults (N=34; mean age +/- SD, 51+/-14y) with SCI and stage II to IV pressure ulcers., Interventions: Subjects were stratified based on wound severity and duration and randomly assigned to receive either a customized, community-based standard wound care (SWC) program that included pressure management or the wound care program plus high-voltage pulsed current applied to the wound bed (EST+SWC)., Main Outcome Measures: Wound healing measured by reduction in wound size and improvement in wound appearance at 3 months of treatment with EST+SWC or SWC., Results: The percentage decrease in wound surface area (WSA) at the end of the intervention period was significantly greater in the EST+SWC group (mean +/- SD, 70+/-25%) than in the SWC group (36+/-61%; P=.048). The proportion of stage III, IV, or X pressure ulcers improving by at least 50% WSA was significantly greater in the EST+SWC group than in the SWC group (P=.02). Wound appearance assessed using the photographic wound assessment tool was improved in wounds treated with EST+SWC but not SWC alone., Conclusions: These results demonstrate that EST can stimulate healing of pressure ulcers of people with SCI. EST can be incorporated successfully into an interdisciplinary wound care program in the community.

Objectives: To estimate the number of minutes a day of leisure time physical activity (LTPA) performed by people with chronic spinal cord injury (SCI) and to identify the demographic and injury-related characteristics associated with LTPA in a population-based sample of people with chronic SCI., Design: Cross-sectional telephone survey., Setting: General community., Participants: Men and women with SCI (N=695)., Interventions: Not applicable., Main Outcome Measures: The number of minutes/day of LTPA performed at a mild intensity or greater., Results: Respondents reported mean minutes +/- SD of 27.14+/-49.36 of LTPA/d; however, 50% reported no LTPA whatsoever. In a multiple regression analysis, sex, age, years postinjury, injury severity, and primary mode of mobility each emerged as a unique predictor of LTPA. Multiple correspondence analysis indicated that being a man over the age of 34 years and greater than 11 years postinjury was associated with inactivity, while being a manual wheelchair user and having motor complete paraplegia were associated with the highest level of daily LTPA., Conclusions: Daily LTPA levels are generally low in people with SCI. Women, older adults, people with less recent injuries, people with more severe injuries, and users of power wheelchairs and gait aids are general subgroups that may require special attention and resources to overcome unique barriers to LTPA. Specific subgroups may also require targeted interventions.

The objective of this study was to examine the relationship between leisure time physical activity (LTPA) and common risk factors for cardiovascular disease (CVD) and type 2 diabetes in community-dwelling adults with chronic spinal cord injury (SCI). LTPA was measured using the Physical Activity Recall Assessment for People with SCI in 76 men and women with chronic (> or =1 year) paraplegia or tetraplegia, living in or near Hamilton, Ontario. Body mass index (BMI), waist circumference, body composition (fat mass (FM) and fat-free mass (FFM)), blood pressure, and biochemical data were collected. Thirty-seven percent (n = 28 participants) were inactive, reporting no LTPA whatsoever, and were compared with an equal-sized group consisting of the most active study participants (> or =25 min of LTPA per day). After adjusting for significant covariates, BMI (18.7%), %FM (19.4%), and C-reactive protein (143%) were all lower, and %FFM was higher (7.2%), in active participants (all p < or = 0.05). Ten percent of active participants vs. 33% of inactive participants were insulin resistant (p = 0.03). Waist circumference (17.6%) and systolic blood pressure (15.3%) were lower in active vs. inactive participants with paraplegia (both p < or = 0.05), but not tetraplegia. In conclusion, greater daily LTPA is associated with lower levels of selected CVD and type 2 diabetes risk factors in individuals living with SCI. Whether this relationship translates into a lower incidence of these chronic diseases has yet to be determined.

Holistic assessment and care are inseparable from the nursing process. Holistic nursing practice informed by a philosophy of holism balancing art and science recognizes the interconnectedness of body, mind, and spirit. Holistic practice draws on knowledge, theories, expertise, intuition, and creativity. The purpose of this article is to place nursing in the context of holistic practice; to explicate the role of presence as an essential condition for holistic care; and to provide an example of the holistic caring process that incorporates theory, presence, and practice documented in the standard formats. A holistic approach to nursing integrates process and presence in the provision of care. Process alone is empty without presence. Presence alone is insufficient without the process.

Aims and Objectives: Access to health information is important for the well-being of people living in the community after spinal cord injury (SCI). In order to design appropriate information interventions, it is critical first to understand the information sources typically used. The goal of this study therefore is to identify the information-seeking practices of this group., Sample and Methods: A sample of 207 individuals living in the community following traumatic spinal cord injury were surveyed regarding their ongoing information needs and practices for seeking information., Results: The results reveal that respondents have unmet information needs, despite the fact that they typically access information through a variety of channels. SCI specialists are the most commonly used source, although they are viewed as relatively inaccessible. By contrast, the Internet (used by a relatively high proportion of respondents) is viewed as comparatively accessible, although there are some concerns about the quality of information found there., Conclusions: These survey results point to the need for an information source that is accessible and delivers high quality information. Although respondents use a variety of information sources, none meets this ideal profile. Information professionals should consider this gap in the design of information interventions.

Spinal cord injury has a profound impact on the storage and voiding functions of the urinary bladder. Loss of autonomic and somatic control mechanisms leads to hypo- or hyperactivity of the bladder wall and sphincters causing problems that range from incontinence to complete loss of the capacity to empty the bladder. This chapter outlines the types of bladder dysfunction that occur after spinal cord injury, their relative prevalence and current practices used to manage the problems. With all the interventions that are available, management of bladder function often still remains a compromise, as the medications and physical interventions available may stimulate or block components of the voiding reflex, but are often not fully restorative in this effort.

Objective: To examine the pharmacokinetics and safety of sustained-release 4-aminopyridine (Fampridine-SR), a potassium channel blocker, in subjects with chronic, incomplete spinal cord injury (SCI)., Design: Open-label., Setting: Clinical research unit in Ontario., Participants: Sixteen neurologically stable subjects with chronic, incomplete SCI (American Spinal Injury Association Impairment Scale grade B, C, or D)., Intervention: Oral administration of Fampridine-SR (25, 30, 35, 40, 50, 60 mg twice daily, each for 1 wk)., Main Outcome Measures: Steady-state pharmacokinetic parameters: maximum observed plasma concentration (Cmax), minimum observed plasma concentration (Cmin), average observed plasma concentration (Cav), area under the plasma concentration-time curve from 0 to 12 hours (AUC(0-12)), time to Cmax (tmax), plasma half-life (t(1/2)), apparent volume of distribution (Vd/F), and apparent total clearance (Cl/F). Safety assessments: physical examinations, vital sign measurements, clinical laboratory tests, electrocardiogram recordings, and adverse events., Results: Mean steady-state Cmax, Cmin, Cav, and AUC(0-12) increased over the entire Fampridine-SR dosage range and were dosage dependent up to 50 mg twice daily. Fampridine-SR had a mean tmax of 2.2 to 3.0 hours and a mean t(1/2) of 5.7 to 6.9 hours. Mean Vd/F (415.4-528.0 L) and Cl/F (51.4-57.7 L/h) were independent of dosage, as were mean tmax and t(1/2) across dosages. Adverse events were mild or moderate and were not dosage related. During the entire study period (17 wk), dizziness was the most frequently reported adverse event, followed by urinary tract infection, paresthesia, ataxia, and insomnia., Conclusion: In subjects with chronic, incomplete SCI, Fampridine-SR was slowly absorbed and eliminated, which will allow Fampridine-SR to be administered in a convenient twice-daily manner. Fampridine-SR was well tolerated at dosages from 25 to 60 mg twice daily.

Fampridine (4-aminopyridine) is a potassium channel blocking agent that restores conduction in demyelinated axons and improves neurologic function in patients with chronic spinal cord injury (SCI). Based on the pharmacokinetic profile of orally administered fampridine, multiple daily doses (4 or more) would need to be taken to sustain its therapeutic effects. Two studies were conducted to determine the pharmacokinetics and safety profile of an oral, sustained-release (SR) formulation of fampridine (fampridine-SR, 10-25 mg) administered as a single dose (n = 14) and twice daily for 1 week (n = 16) in patients with chronic, incomplete SCI. Mean plasma concentrations and area under the plasma concentration-time curve were proportional to the dose administered, whereas other pharmacokinetic parameters were independent of dose. Fampridine-SR was absorbed slowly (peak plasma concentration shortly after dosing, 2.6-3.7 hours) and eliminated (plasma half-life, 5.6-7.6 hours), and reached steady state after 4 days of twice-daily administration. Fampridine-SR was well tolerated, with only mild to moderate adverse events reported, and no serious adverse events. The extended plasma half-life of fampridine-SR allows convenient twice-daily dosing. Clinical trials designed to assess neurologic and functional improvement using fampridine-SR in patients with chronic SCI are currently underway.

Objective: To determine the degree of association among indices of preserved sensation derived from quantitative sensory testing (QST), somatosensory evoked potentials (SEPs), and the clinical characteristics of patients with spinal cord injury (SCI)., Design: A controlled correlational study of diverse measures of preserved sensory function., Setting: Regional SCI rehabilitation center in Ontario, Canada., Participants: Thirty-three patients with incomplete SCI and 14 able-bodied controls., Interventions: Not applicable., Main Outcome Measures: QST measures of perceptual threshold for temperature and vibration, American Spinal Injury Association sensory scores (light touch, pinprick), and tibial nerve SEPs., Results: There was a low degree of association (kappa) between QST results and sensory scores (|kappa|=.05-.44). QST measures yielded greater numbers of patients with SCI being classified as impaired, suggesting a greater sensitivity of QST to detect more subtle sensory deficits. QST measures of vibration threshold generally corresponded to the patients' SEP recordings. QST measures of modalities conveyed within the same tract were significantly (P<.05) correlated (|r|=.46-.84) in patients with SCI, but not in controls, whereas those modalities mediated by different pathways had lower and generally nonsignificant correlations (|r|=.05-.44) in both patients and controls., Conclusions: The low degree of association between QST measures and sensory scores is likely attributable to measurement limitations of both assessments, as well as various neuroanatomic and neuropathologic factors. QST provides more sensitive detection of preserved sensory function than does standard clinical examination in patients with incomplete SCI., (Copyright 2002 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation)

This study characterized the proinflammatory cytokines, interleukin-2 (IL-2) and tumor necrosis factor alpha (TNFalpha), the antiinflammatory cytokines, IL-4 and IL-10, autoantibodies specific for GM1 ganglioside (anti-GM1), IgG and IgM, and myelin-associated glycoprotein (anti-MAG), in the sera of infection-free, chronic (>12 months), traumatically injured SCI patients (n = 24). Healthy able-bodied subjects (n = 26) served as controls. The proinflammatory cytokines and anti-GM1 antibodies were of particular interest as they have been implicated in an autoimmune "channelopathy" component to central and peripheral conduction deficits in various chronic neuroinflammatory diseases. Antibody and cytokine titers were established using enzyme-linked immunosorbent assays (ELISA). The mean anti-GM(1) (IgM) titer value for the SCI group was significantly higher (p < 0.05) than controls. The SCI group also demonstrated significantly higher titers (p < 0.05) of IL-2 and TNF alpha than controls. No differences were found between the SCI group and control group mean levels of IL-4 or IL-10. Overall, the serum of 57% of SCI patients contained increased levels of autoantibodies or proinflammatory cytokines relative to control values. These results provide preliminary support for the hypothesis that chronic immunological activation in the periphery occurs in a subpopulation of chronic SCI patients. It remains to be established whether elevated serum titers of proinflammatory cytokines and autoantibodies against GM1 are beneficial to the patients or whether they are surrogate markers of a channelopathy that compounds the neurological impairment associated with traumatic axonopathy or myelinopathy.

4-Aminopyridine (4-AP) is a potassium (K+) channel blocking agent that has been shown to reduce the latency and increase the amplitude of motor evoked potentials (MEPs) elicited with transcranial magnetic stimulation (TMS) in patients with chronic spinal cord injury (SCI). These effects on MEPs are thought to reflect enhanced conduction in long tract axons brought about by overcoming conduction deficits due to focal demyelination and/or by enhancing neuroneuronal transmission at one or more sites of the neuraxis. The present study was designed to obtain further evidence of reduced central motor conduction time (CMCT) and to determine whether MEPs could be recorded from paretic muscles in which they were not normally elicited. MEPs were elicited with TMS being delivered to subjects (n = 25) pre- and post-administration of 4-AP (10 mg capsule) or placebo. The principal finding was that 4-AP lowered the stimulation threshold, increased the amplitude and reduced the latency of MEPs in all muscles tested, including those that were unimpaired, but did not alter measures of the peripheral nervous system (i.e., M-wave, H-reflex, F-wave). These 4-AP-induced changes in MEPs were significantly greater than those seen with placebo (p < 0.05). The primary implication of these results is that a low dose of 4-AP (immediate-release formulation) appears to improve the impaired central motor conduction of some patients with incomplete SCI. This is most likely attributable to overcoming conduction deficits at the site of injury but may also involve an increase in cortical excitability.

Objective: To develop an objective and uniform means for classifying patients with incomplete spinal cord injury (SCI) according to SCI syndromes., Design: Criteria for assigning the syndromes (defined by the International Standards for Neurological and Functional Classification of SCI Patients) were operationalized by means of sensory and motor scores and were incorporated into a set of six independent algorithms and two composite algorithms., Setting: A regional SCI rehabilitation center in Canada., Patients: SCI patients (n = 56) with incomplete injuries (American Spinal Injury Association classes B, C, D) and stable neurologic deficits., Results: Individual algorithms allowed the highest classification rate but with some patients meeting the criteria for more than one syndrome. A composite, differential allocation algorithm, with selected thresholds at decision nodes, yielded a classification rate approximating that of the individual algorithms but without double classifications., Conclusions: The composite algorithm provided an objective and standardized means of assigning patients to syndromes based on clinically measurable sensory and motor scores. The thresholds used to implement criteria and the order of decision nodes greatly influenced the outcomes and may be adjusted to suit the needs of the classification, that is, embracing liberal or stringent criteria. Controversy remains about the interpretation of some syndromes, and many patients remain unclassifiable because of mixed clinical presentation.

Fampridine SR (4-aminopyridine) is a potassium channel-blocking drug currently being investigated for its therapeutic efficacy in ameliorating central conduction deficits due to demyelination in patients with spinal cord injury (SCI). The present open-label pharmacokinetic trial examined the absorption characteristics of a sustained-release form of the drug in 25 SCI subjects with chronic incomplete injuries. The overall group mean Cmax of 27.7 +/- 6.2 ng/mL occurred at a tmax of 3.4 +/- 1.4 hours. AUC0-12 was 210.5 +/- 49.5 ng/mL.h. For paraplegics, AUCtmax was 76.02 +/- 33.28 and for tetraplegics was significantly less at 51.25 +/- 20.36 (p = 0.037). A statistically significant difference in the initial rate and extent of absorption, but not in total 4-AP bioavailability over the 12-hour study period, was evident between tetraplegic patients, 0.60 +/- 0.23, and paraplegic patients, 0.39 +/- 0.14 (p = 0.02). There was a linear correlation (p < 0.05) between the neurological level of injury and Cmax/AUCtmax. These results confirm and extend previous observations of different rates of drug absorption among SCI patients with lesions above and below the sympathetic outflow (T6) and provide evidence of the absorption characteristics of this sustained-release form of 4-aminopyridine, which is helpful for optimal dosing.

A randomized double-blind dose-titration crossover trial of the safety and efficacy of oral fampridine-SR (sustained release 4-aminopyridine) was conducted on spinal cord injured (SCI) patients at two centers. Twenty-six patients (n = 26) with incomplete lesions completed the trial. These patients all had chronic (>2 years) and stable neurological deficits. They received fampridine-SR 12.5 and 17.5 mg b.i.d. over a 2-week treatment period, followed by a 1-week washout and 2 weeks of placebo, or vice versa. Patients reported significant benefit of fampridine-SR over placebo on patient satisfaction (McNemar's test, p2 < 0.05) and quality of life scores (p2 < 0.01). Sensory scores (p1 < 0.01), including both pin prick (p1 = 0.059) and light touch (p1 = 0.058), and motor scores (adjusted to reflect only paretic segments) (p1 < 0.01) all yielded evidence of benefit of fampridine-SR over placebo. The Ashworth scale of spasticity was significantly (p2 < 0.05) reduced when patients received fampridine-SR. There were no statistically significant benefits of the drug on measures of pain or bowel, bladder and sexual function, or functional independence. Side effects of lightheadedness and nausea were transient and trivial relative to efficacy, and approximately 30% of patients reported a wish to continue to use fampridine-SR. The clinical benefits most likely derive from the K+ channel blocking action of the drug. Potassium channel blockade enhances axonal conduction across demyelinated internodes and enhances neuroneuronal and neuromuscular transmission in preserved axons. These results provide the first evidence of therapeutic benefit of fampridine-SR in SCI patients.

Preclinical trials of intravenously administered 4-Aminopyridine (4-AP) have demonstrated transient improvements in neurological function in patients with longstanding spinal cord injury (SCI). The present report describes three patients with SCI who responded favourably in preclinical trials and who were subsequently administered oral (capsule) 4-AP (10 mg b.i.d. or t.i.d.) over a 4 month interval. The three patients (two male: 1 female) all had incomplete tetraplegia (ASIA levels C and D) with the neurological level of the lesion between C5-C7. Following the administration of 4-AP the patients demonstrated marked and sustained reductions in upper (n = 1) or lower extremity (n = 2) spasticity. Other clinical benefits of 4-AP were reduced pain (n = 1), restored muscle strength (n = 3), improved sensation (n = 2), voluntary control of bowel function (n = 1), and sustained penile tumescence (n = 2). The patients exhibited improved hand function (n = 1), enhanced mobility in transfers and gait (n = 2), with improved energy and endurance. Only trivial side effects (transient light-headedness) were observed. In one case, the enhanced neurological function allowed the patient to stand with support for the first time post injury (16 years). The time course of therapeutic response to the initial dose matched the pharmacokinetic elimination profile derived from serum and urine analysis. There was no evidence of renal or hepatic toxicity with prolonged use. These results indicate a therapeutic benefit of oral 4-Aminopyridine in the management of various neurological deficits in a select group of SCI patients.

The potassium (K+) channel-blocking agent 4-aminopyridine (4-AP) is currently being investigated for its potential therapeutic value in patients with spinal cord injury (SCI). The present study was designed to test the hypothesis that 4-AP ameliorates central motor conduction deficits in individuals with SCI. Oral 4-AP (10 mg) was administered to 19 (n = 19) SCI subjects with stable neurological deficits. Their response to the drug was monitored using motor evoked potentials (MEPs) following transcranial magnetic stimulation of motor cortex and various measures of segmental or peripheral reflex activity (F-waves, H-reflex, and M-response) recorded from lower limb muscles. The mean MEP amplitude in the extensor digitorum brevis muscle (left) was significantly (p < .05) increased from x = .25 +/- .42 mV to x = .59 +/- 1.04 mV at 2 h after drug administration, and the cortical stimulation threshold was reduced (p < .05) by 5.8%. Similar results were obtained in all subjects exhibiting MEPs (n = 13) and in all muscles (n = 6) studied. These changes were maintained at 4 h postdrug. MEP latencies were reduced in all subjects who initially exhibited abnormally prolonged MEP latencies relative to control group (n = 13) values. F-wave, H-reflex, and M-response values (latency and amplitude) were not systematically altered by 4-AP, leading to the conclusion that it was central motor conduction that was enhanced. This interpretation was supported by observed reductions in central motor conduction time (CMCT) in the majority of SCI subjects from whom CMCT measurements were obtained, two of whom anecdotally reported improved motor control after 4-AP, and by increased MEP:M-wave amplitude ratios. The MEP:M-wave ratios indicated that the magnitude of the effect of 4-AP on motoneuron recruitment was not large, in absolute terms (<4% motoneuron pool), but was appreciable relative to the initial level of motoneuron recruitment. These results provide the first statistically significant, objective evidence of improved functioning of the neuromuscular system in chronically injured SCI subjects receiving 4-AP and suggest that the improvements are mediated through enhanced central conduction. The results further support the emerging view that pharmaceutical management of central conduction deficits may prove to be a useful therapeutic strategy for some patients with long-standing SCI.

Conditioning of lower limb H-reflexes by transcranial magnetic stimulation of motor cortex was used to detect preserved innervation in patients with long-standing spinal cord injury (SCI). Cortical stimulation was delivered at intensities suprathreshold or subthreshold for evoking motor evoked potentials (MEPs). The conditioning (C) cortical stimulation preceded the test (T) H-reflex stimulus at intervals between C-T: 10-300 msec. Conditioned H-reflex profiles in control subjects (n = 10), following both suprathreshold and subthreshold cortical conditioning, yielded evidence of early (C-T: 10-30 msec) and late arriving (C-T: 60-130 msec) excitatory inputs to the lateral gastrocnemius (LG) motoneuron pool. Demonstration of late inputs following subthreshold cortical conditioning suggested the inputs are mediated by slow conducting or oligosynaptic descending motor tracts, as distinct from afferent consequences of short latency MEPs. In SCI patients (n = 11) the conditioned H-reflex profile varied according to the patients' ASIA impairment rating. Higher functioning SCI patients (ASIA level C and D) revealed evidence of both early and late arriving inputs to the lumbosacral motoneuron pool whereas patients with more severe impairments (ASIA levels A and B) most often failed to exhibit early or late periods of H-reflex facilitation in LG. In three patients (i.e., 1 ASIA B; 2 ASIA C) the cortical modulation of H-reflex amplitudes yielded evidence of preserved corticospinal innervation that was not detectable by other MEP reinforcement procedures. These results introduce the cortical conditioning procedure as a sensitive means of detecting latent corticospinal and/or bulbospinal innervation in SCI patients consistent with the emerging neuropathological picture of preserved axonal integrity in descending motor tracts in the face of extensive functional loss.

The physical demands of performing on musical instruments can cause pain, sensory loss, and lack of coordination. Five cases illustrate common problems. Knowledge of the interaction between the technique of playing the instrument and the particular musician can help physicians diagnose and resolve problems.