A Randomized, Controlled Trial of Methylprednisolone or Naloxone in the Treatment of Acute Spinal-Cord Injury

Bracken, Michael B.; Shepard, Mary Jo; Collins, William F.; Holford, Theodore R.; Young, William A.; Baskin, David S.; Eisenberg, Howard M.; Flamm, Eugene S.; Maroon, J. C.; Marshall, Lawrence F.; Perot, Phanor L.; Piepmeier, Joseph M.; Sonntag, Volker K. H.; Wagner, Franklin C.; Wilberger, James E.; Winn, H. Richard

doi:10.1097/00132586-199102000-00048

Cited by 273 publications

(383 citation statements)

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“…Three large, double-blind, placebocontrolled pharmaceutical trials focussed on acute neuroprotection and rehabilitation in SCI are reported in the literature; the National Acute Spinal Cord Injury Study (NASCIS), Sygen and GK-11 trials. [2][3][4][5][6][7][8] The data from the placebo-control groups in these studies allow the natural history of recovery from injury to be examined within the context of a randomized controlled trial (RCT). In addition, there have been a number of studies of long-term outcomes after SCI that provide valuable information on expected recovery rates, [10][11][12] as well as some recently unpublished data from the European Multicenter study in Spinal Cord Injury (EMSCI).…”

Section: Sources Of Datamentioning

confidence: 99%

Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: spontaneous recovery after spinal cord injury and statistical power needed for therapeutic clinical trials

et al. 2006

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The International Campaign for Cures of Spinal Cord Injury Paralysis (ICCP) supported an international panel tasked with reviewing the methodology for clinical trials in spinal cord injury (SCI), and making recommendations on the conduct of future trials. This is the first of four papers. Here, we examine the spontaneous rate of recovery after SCI and resulting consequences for achieving statistically significant results in clinical trials. We have reanalysed data from the Sygen trial to provide some of this information. Almost all people living with SCI show some recovery of motor function below the initial spinal injury level. While the spontaneous recovery of motor function in patients with motor-complete SCI is fairly limited and predictable, recovery in incomplete SCI patients (American spinal injury Association impairment scale (AIS) C and AIS D) is both more substantial and highly variable. With motor complete lesions (AIS A/AIS B) the majority of functional return is within the zone of partial preservation, and may be sufficient to reclassify the injury level to a lower spinal level. The vast majority of recovery occurs in the first 3 months, but a small amount can persist for up to18 months or longer. Some sensory recovery occurs after SCI, on roughly the same time course as motor recovery. Based on previous data of the magnitude of spontaneous recovery after SCI, as measured by changes in ASIA motor scores, power calculations suggest that the number of subjects required to achieve a significant result from a trial declines considerably as the start of the study is delayed after SCI. Trials of treatments that are most efficacious when given soon after injury will therefore, require larger patient numbers than trials of treatments that are effective at later time points. As AIS B patients show greater spontaneous recovery than AIS A patients, the number of AIS A patients requiring to be enrolled into a trial is lower. This factor will have to be balanced against the possibility that some treatments will be more effective in incomplete patients. Trials involving motor incomplete SCI patients, or trials where an accurate assessment of AIS grade cannot be made before the start of the trial, will require large subject numbers and/or better objective assessment methods.

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Section: Sources Of Datamentioning

confidence: 99%

Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: spontaneous recovery after spinal cord injury and statistical power needed for therapeutic clinical trials

et al. 2006

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“…[15][16][17][18][19][20] The ISCSCI motor and sensory exams have also been used as inclusion criteria for entry into drug and device trials. [21][22][23][24][25][26][27][28] While the work by Bracken 21 added additional upper extremity muscles and variation in the scoring technique, the study used neurological motor level as the primary outcome in the study on high-dose methylprednisolone. Outcomes of activity-based rehabilitation, a program of intensive cycling, assisted treadmill training and swimming, also use the International standards as primary outcomes.…”

Section: Introductionmentioning

confidence: 99%

The International Standards for Neurological Classification of Spinal Cord Injury: reliability of data when applied to children and youths

et al. 2006

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Study design: Intra-rater reliability study, cross-sectional design. Objectives: To determine reliability of the International Standards for Neurological Classification of Spinal Cord Injury (ISCSCI) motor and sensory exam in children. Setting: Nonprofit pediatric hospital. Methods: In all, 74 subjects had two trials of the motor and sensory exams. Intraclass correlation coefficients (ICC), 95% confidence intervals (CI) were generated for total motor (TM), pin prick (PP) and light touch (LT) scores for the entire sample, four age groups, severity and type of injury.

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“…13 Using the MRC 5-point grading scale, power was assessed bilaterally in deltoid, biceps. triceps, flexor carpi radialis, exten sor carpi radialis, and abductor pollicis brevis in the upper limbs, and iliopsoas, hip extensors, hamstrings, quadriceps, tibialis anterior, gastrocnemius, and extensor hallu cis longus in the lower limbs.…”

Section: Clinical Evaluationmentioning

confidence: 99%

Prognostic value of cortical magnetic stimulation in spinal cord injury

Clarke

Modarres-Sadeghi²,

Twomey³

et al. 1994

Spinal Cord

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Cortical magnetic stimulation was performed in a consecutive series of 10 patients presenting within 15 days of traumatic spinal cord injury. In those patients with complete paraplegia or quadriplegia, motor evoked potentials at presentation were absent below the level of the lesion. Six months after the injury, potentials had returned in the biceps brachii and abductor pollicis brevis muscles in some quadriplegic cases, but remained absent from the tibialis anterior in all of this group. None of those with a complete lesion made a significant functional recovery. Of the three patients with incomplete quadri plegia, two showed a significant recovery after 6 months. Motor evoked potentials were recordable below the level of the lesion at presentation in these cases, although the latencies were prolonged. In the remaining patient who failed to improve, potentials were unrecordable throughout the study. This small pilot study suggests that cortical magnetic stimulation may be useful in refining the prognosis in patients with an incomplete spinal cord injury.

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A Randomized, Controlled Trial of Methylprednisolone or Naloxone in the Treatment of Acute Spinal-Cord Injury

Cited by 273 publications

References 0 publications

Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: spontaneous recovery after spinal cord injury and statistical power needed for therapeutic clinical trials

Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: spontaneous recovery after spinal cord injury and statistical power needed for therapeutic clinical trials

The International Standards for Neurological Classification of Spinal Cord Injury: reliability of data when applied to children and youths

Prognostic value of cortical magnetic stimulation in spinal cord injury

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