The pharmacologic management of acute spinal cord injury in humans remains equivocal despite decades of animal clinical investigation. The National Acute Spinal Cord Injury Study (NASCIS) was established in 1977 to evaluate new treatment modalities using a multi-center randomized clinical trial (RCT) methodology. The first RCT (NASCIS I) was successfully completed in 1983. Recent animal data suggests that high doses of Methylprednisolone (30 mg/k and Naloxone (5 mg/k) may be efficacious in improving neurological recovery after acute spinal cord injury. It is proposed to compare these drugs against placebo in a double blind RCT at twelve medical centers. The study protocols will be modified after existing ones already developed by the study group. Eligible spinal cord injury patients will be randomized to one of three treatment arms within 18 hours fo injury. Standardized neurologic exams will be given on admission, 24, 48 and 72 hours, and six weeks, six months and one year after injury. Improvement in motor function, pinprick, light touch and deep pressure sensation are the major study outcome measures. Morbidity and mortality, especially as they relate to drug treatment, will be monitored throughout the trial and studied in detail. A total of 480 patients will be randomized. Potential confounding and effect modifying factors will be examined and controlled using log linear models and logistic regression analyses. The National Acute Spinal Cord Injury Study is one of the most detailed, standardized and complete data sets of the management of acute spinal cord injury available. It will also be used, therefore, to test hypotheses concerning the potential advantages of surgical and other management procedures in improving neurological outcomes.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project (R01)
Project #
5R01NS015078-08
Application #
3395955
Study Section
Neurological Disorders Program Project Review A Committee (NSPA)
Project Start
1979-02-01
Project End
1988-07-31
Budget Start
1986-08-01
Budget End
1987-07-31
Support Year
8
Fiscal Year
1986
Total Cost
Indirect Cost
Name
Yale University
Department
Type
Schools of Medicine
DUNS #
082359691
City
New Haven
State
CT
Country
United States
Zip Code
06520
Bracken, Michael B; Holford, Theodore R (2002) Neurological and functional status 1 year after acute spinal cord injury: estimates of functional recovery in National Acute Spinal Cord Injury Study II from results modeled in National Acute Spinal Cord Injury Study III. J Neurosurg 96:259-66
Bracken, M B (2001) Methylprednisolone and acute spinal cord injury: an update of the randomized evidence. Spine (Phila Pa 1976) 26:S47-54
Bracken, M B (2000) Methylprednisolone and spinal cord injury. J Neurosurg 93:175-9
Shepard, M J; Bracken, M B (1999) Magnetic resonance imaging and neurological recovery in acute spinal cord injury: observations from the National Acute Spinal Cord Injury Study 3. Spinal Cord 37:833-7
Bracken, M B; Shepard, M J; Holford, T R et al. (1998) Methylprednisolone or tirilazad mesylate administration after acute spinal cord injury: 1-year follow up. Results of the third National Acute Spinal Cord Injury randomized controlled trial. J Neurosurg 89:699-706
Shepard, M J; Saftlas, A F; Leo-Summers, L et al. (1998) Maternal anthropometric factors and risk of primary cesarean delivery. Am J Public Health 88:1534-8
Bracken, M B; Shepard, M J; Holford, T R et al. (1997) Administration of methylprednisolone for 24 or 48 hours or tirilazad mesylate for 48 hours in the treatment of acute spinal cord injury. Results of the Third National Acute Spinal Cord Injury Randomized Controlled Trial. National Acute Spinal Cord Injury JAMA 277:1597-604
Zhang, H; Bracken, M B (1996) Tree-based, two-stage risk factor analysis for spontaneous abortion. Am J Epidemiol 144:989-96
Shepard, M J; Bracken, M B (1994) The effect of methylprednisolone, naloxone, and spinal cord trauma on four liver enzymes: observations from NASCIS 2. National Acute Spinal Cord Injury Study. Paraplegia 32:236-45
Duh, M S; Shepard, M J; Wilberger, J E et al. (1994) The effectiveness of surgery on the treatment of acute spinal cord injury and its relation to pharmacological treatment. Neurosurgery 35:240-8;discussion 248-9

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