Natural history of neurological improvement following complete (AIS A) thoracic spinal cord injury across three registries to guide acute clinical trial design and interpretation

Model System:

SCI

Reference Type:

Journal article

Accession No.:

J82487

Journal:

Spinal Cord (formerly Paraplegia)

Year, Volume, Issue, Page(s):

2019 , 57, 9, 753-762

Publication Website:

Abstract:

Study compiled neurological recovery data from three established spinal cord injury (SCI) registries: the North American Clinical Trial Network (NACTN), the European Multicenter Study about Spinal Cord Injury (EMSCI), and the Spinal Cord Injury Model Systems (SCIMS). The purpose was to establish a modern-day international benchmark for neurological recovery following traumatic complete thoracic sensorimotor SCI in a population similar to those enrolled in acute clinical trials. Analysis included only traumatic thoracic-injured patients between 2006 and 2016 meeting commonly used clinical trial inclusion/exclusion criteria such as: age 16-70, T2-T12 neurological level of injury (NLI), ASIA Impairment Scale (AIS) A, non-penetrating injury, acute neurological exam within 7 days of injury, and follow-up neurological exam at least 6 months post injury. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) outcomes including AIS conversion rate, NLI, and sensory and motor scores/levels were compiled. A total of 170 patients were included from the three registries: 12 from NACTN, 64 from EMSCI, and 94 from SCIMS. AIS conversion rates at approximately 6 months post injury varied from 16.7 to 23.4 percent. Improved conversion rates were observed in all registries for low thoracic (T10-T12) injuries when compared with high/mid thoracic (T2-T9) injuries. The NLI was generally stable and lower-extremity motor score improvement was uncommon and usually limited to low thoracic injuries only. This study presents the aggregation of selected multinational natural history recovery data in thoracic AIS A patients from three SCI registries and demonstrates comparable minimal improvement of ISNCSCI-scored motor and sensory function following these injuries, whereas conversions to higher AIS grades occur at a frequency of about 20 percent. These data inform the development of future clinical trial protocols in this important patient population for the interpretation of the safety and potential clinical benefit of new therapies, and the potential applicability in a multinational setting.

Author(s):