Time-to-enrollment in clinical trials investigating neurological recovery in chronic spinal cord injury: observations from a systematic review and ClinicalTrials.gov database

This study investigates the impact of the time between spinal cord injury (SCI) and enrollment in clinical trials on the outcomes of regenerative therapies for chronic SCI. The researchers analyzed data from ClinicalTrials.gov and individual patient data from nine clinical trials to evaluate how the time-to-enrollment affects motor and sensory improvements. The study found that enrolling patients with a wide range of injury durations may lead to imprecise outcomes, suggesting that clinical trial designs should consider appropriate post-injury time frames to assess therapeutic benefit.

• 1
  The majority of chronic SCI trials in ClinicalTrials.gov do not restrict the maximum post-injury time for trial eligibility.
• 2
  There are varying degrees of motor and sensory improvement among different time-to-enrollment groups in regenerative therapy trials.
• 3
  The average improvement in motor scores for baseline AIS A was 6.59 ± 5.14 in the Group 1, 6.85 ± 5.98 in the Group 2 and 2.46 ± 4.14 in the Group 3.