Electrophysiological Outcome Measures in Spinal Cord Injury Clinical Trials: A Systematic Review.

Abstract

Background: Electrophysiological measures are being increasingly utilized due to their ability to provide objective measurements with minimal bias and to detect subtle changes with quantitative data on neural function. Heterogeneous reporting of trial outcomes limits effective interstudy comparison and optimization of treatment. Objective: The objective of this systematic review is to describe the reporting of electrophysiological outcome measures in spinal cord injury (SCI) clinical trials in order to inform a subsequent consensus study. Methods: A systematic search of PubMed and EMBASE databases was conducted according to PRISMA guidelines. Adult human SCI clinical trials published in English between January 1, 2008 and September 15, 2018 with at least one electrophysiological outcome measure were eligible. Findings were reviewed by all authors to create a synthesis narrative describing each outcome measure. Results: Sixty-four SCI clinical trials were included in this review. Identified electrophysiological outcomes included electromyography activity (44%), motor evoked potentials (33%), somatosensory evoked potentials (33%), H-reflex (20%), reflex electromyography activity (11%), nerve conduction studies (9%), silent period (3%), contact heat evoked potentials (2%), and sympathetic skin response (2%). Heterogeneity was present in regard to both methods of measurement and reporting of electrophysiological outcome measures. Conclusion: This review demonstrates need for the development of a standardized reporting set for electrophysiological outcome measures. Limitations of this review include exclusion of non-English publications, studies more than 10 years old, and an inability to assess methodological quality of primary studies due to a lack of guidelines on reporting of systematic reviews of outcome measures.