The Integrated Neurological Change Score Is a Sensitive Neurological Composite Measure to Evaluate Cervical Spinal...

Area of Science:

• Neurology
• Clinical Trials
• Rehabilitation Medicine

Background:

• The International Standards for Spinal Cord Injury Classification (ISNCSCI) provides subscores for neurological assessment.
• Developing composite measures can enhance sensitivity to therapeutic changes in spinal cord injury (SCI).

Purpose of the Study:

• To evaluate the Integrated Neurological Change Score (INCS) for sensitivity to therapeutic outcomes in acute cervical SCI.
• To assess the INCS's robustness against ceiling effects and its association with functional improvement.
• To validate the INCS as a composite measure in SCI clinical trials.

Main Methods:

• Retrospective analysis of data from the Nogo Inhibition in Spinal Cord Injury (NISCI) trial and the European Multicenter Study about Spinal Cord Injury (EMSCI) cohort.
• Comparison of INCS sensitivity and ceiling effect susceptibility against ISNCSCI motor scores.
• Correlation analysis between INCS and functional outcomes (self-care, walking ability).

Main Results:

• INCS demonstrated sensitivity to the therapeutic effect of NG-101, comparable to the Upper Extremity Motor Score.
• INCS exhibited reduced susceptibility to ceiling effects compared to ISNCSCI motor scores in both trial and cohort data.
• INCS showed strong correlations with functional outcomes, outperforming ISNCSCI motor scores.

Conclusions:

• The Integrated Neurological Change Score (INCS) is a sensitive and robust measure for neurological changes in acute cervical SCI.
• INCS's properties support its use in clinical trials, potentially enabling more inclusive designs.
• The INCS validates the utility of ISNCSCI standards for comprehensive SCI outcome assessment.