Injury to Time of Marked Recovery as a New Acute Spinal Cord Injury Outcome Measurement for Statistical Analysis of...

No pharmacologic agent has demonstrated long-term neurological recovery following acute traumatic spinal cord injury (ATSCI). Thus, consideration of alternative outcome indicators is reasonable. A new and novel outcome variable, time to recovery, is introduced and compared to long-term recovery, examining nine variables for a two-grade improvement (Marked Recovery [MR]). The updated historical US FDA IND SYGEN ATSCI database (n = 760 patients) was used, as it is unique in having sufficient neurological examinations (4, 8, 16, 26, and 52 weeks) to allow the analysis. The time to MR was defined as the geometric mean between the time to first MR and the preceding examination with no MR. The SYGEN group exhibited the maximum fractional MR disparity at 8 weeks (p = 0.0248), coinciding with the discontinuation of the SYGEN study drug treatment. In the model fit analysis using long-term MR outcomes (26-52 weeks), significant variables were ASIA Injury Score (AIS) baseline grade (p < 0.0001), cervical versus thoracic injury (p = 0.0334), and direct admission versus transfer to spinal cord injury center (p = 0.0269). In the model fit analysis using time to MR, significant variables were AIS baseline grade (p < 0.0001), SYGEN versus placebo (p = 0.0227), age <30 years old (p = 0.0248), and early surgery ≤72 h (p = 0.0350). For time to MR, the combined effects of SYGEN and early surgery were additive, with a total decrease of 40.87 days (p = 0.0041) compared with placebo and late surgery. The time to MR is a new and novel metric for evaluating differences in recovery, as demonstrated by finding significant statistical relationships in several variables. The mechanism of action of a shortening of time to MR between groups after ATSCI is an augmentation of the body's inherent neurological healing process. Clinically, this results in shorter rehabilitation time.