Abstract
Study design
Narrative review.
Objectives
To discuss how electrophysiology may contribute to future clinical trials in spinal cord injury (SCI) in terms of: (1) improvement of SCI diagnosis, patient stratification and determination of exclusion criteria; (2) the assessment of adverse events; and (3) detection of therapeutic effects following an intervention.
Methods
An international expert panel for electrophysiological measures in SCI searched and discussed the literature focused on the topic.
Results
Electrophysiology represents a valid method to detect, track, and quantify readouts of nerve functions including signal conduction, e.g., evoked potentials testing long spinal tracts, and neural processing, e.g., reflex testing. Furthermore, electrophysiological measures can predict functional outcomes and thereby guide rehabilitation programs and therapeutic interventions for clinical studies.
Conclusion
Objective and quantitative measures of sensory, motor, and autonomic function based on electrophysiological techniques are promising tools to inform and improve future SCI trials. Complementing clinical outcome measures, electrophysiological recordings can improve the SCI diagnosis and patient stratification, as well as the detection of both beneficial and adverse events. Specifically composed electrophysiological measures can be used to characterize the topography and completeness of SCI and reveal neuronal integrity below the lesion, a prerequisite for the success of any interventional trial. Further validation of electrophysiological tools with regard to their validity, reliability, and sensitivity are needed in order to become routinely applied in clinical SCI trials.
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Funding
Funding was provided by the American Spinal Injury Association (ASIA), Christopher and Dana Reeve Foundation (CDRF), Craig H. Neilsen Foundation (CHN), International Research Foundation for Paraplegia (IRP), Rick Hansen Institute (RHI), Spinal Cord Outcomes Partnership Endeavor (SCOPE), Spinal Research (SR), Wings for Life (WfL).
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MH was responsible for manuscript assembly, conducting the search, compiling the patient cases, creating the Table and writing the manuscript. MS was responsible for conducting research, compiling the patient cases and writing the manuscript. All remaining authors (JLKK, CRJ, JR, JCF, and KET) contributed individually by conducting the search and writing individual sections of the manuscript.
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We certify that all applicable institutional and governmental regulations concerning the ethical use of human volunteers were followed during the data collection for patient examples provided in this manuscript. The local ethics board ‘Kantonale Ethikkommission Zürich, KEK’ (EK-04/2006, PB_2016-02051, clinicaltrial.gov number: NCT02138344) has approved this data collection.
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Hubli, M., Kramer, J.L.K., Jutzeler, C.R. et al. Application of electrophysiological measures in spinal cord injury clinical trials: a narrative review. Spinal Cord 57, 909–923 (2019). https://doi.org/10.1038/s41393-019-0331-z
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DOI: https://doi.org/10.1038/s41393-019-0331-z
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