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

Top Spinal Cord Inj Rehabil, 2019 · DOI: 10.1310/sci2504-340 · Published: October 1, 2019

Spinal Cord Injury Physiology Research Methodology & Design

Simple Explanation

Electrophysiological measures are objective ways to measure neural function, providing quantitative data with minimal bias. They are increasingly used in spinal cord injury (SCI) clinical trials. This systematic review describes how electrophysiological outcome measures are reported in SCI clinical trials. The aim is to provide information for a subsequent consensus study to standardize these measures. The review found heterogeneity in both the measurement methods and reporting of electrophysiological outcome measures. This highlights the need for standardized reporting in this field.

Study Duration

January 1, 2008 and September 15, 2018

Participants

877 people with SCI and 324 controls

Evidence Level

Systematic Review

Key Findings

1
The most commonly used electrophysiological measures were electromyography (EMG), motor evoked potentials (MEPs), somatosensory evoked potentials (SSEPs), and H-reflex.
2
There was significant heterogeneity in how these measures were collected and reported across different studies.
3
Only a small percentage of studies (9%) reported sample size justification, and a notable portion (28%) acknowledged small sample size as a limitation.

Research Summary

This systematic review examined the use of electrophysiological (EP) outcome measures in spinal cord injury (SCI) clinical trials, revealing significant variation in assessment methods and reporting practices. The review highlights the need for standardized reporting of EP outcome measures to facilitate interstudy comparison and reduce bias. Key EP measures identified include EMG activity, MEPs, SSEPs, and H-reflex. The authors propose the development of standardized reporting guidelines using the Delphi method to achieve consensus among experts in the field.

Practical Implications

Standardized Reporting Guidelines

Development of standardized guidelines for collecting and reporting EP outcomes in SCI clinical trials is needed.

Improved Interstudy Comparison

Standardized reporting will facilitate better comparison of results across different studies.

Enhanced Outcome Prediction

Standardized EP measures may play a role in SCI outcome predictions.

Study Limitations

1
Exclusion of non-English publications.
2
Exclusion of studies older than 10 years.
3
Inability to assess methodological quality of primary studies due to lack of guidelines.

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