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Guidelines for the conduct of clinical trials in spinal cord injury: Neuroimaging biomarkers

Maryam Seif, Claudia A. M. Gandini Wheeler-Kingshott, Julien Cohen-Adad, Adam E. Flanders, Patrick Freund

Article (2019)

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Abstract

Traumatic spinal cord injury (SCI) leads to immediate neuronal and axonal damage at the focal injury site and triggers secondary pathologic series of events resulting in sensorimotor and autonomic dysfunction below the level of injury. Although there is no cure for SCI, neuroprotective and regenerative therapies show promising results at the preclinical stage. There is a pressing need to develop non-invasive outcome measures that can indicate whether a candidate therapeutic agent or a cocktail of therapeutic agents are positively altering the underlying disease processes. Recent conventional MRI studies have quantified spinal cord lesion characteristics and elucidated their relationship between severity of injury to clinical impairment and recovery. Next to the quantification of the primary cord damage, quantitative MRI measures of spinal cord (rostrocaudally to the lesion site) and brain integrity have demonstrated progressive and specific neurodegeneration of afferent and efferent neuronal pathways. MRI could therefore play a key role to ultimately uncover the relationship between clinical impairment/recovery and injury-induced neurodegenerative changes in the spinal cord and brain. Moreover, neuroimaging biomarkers hold promises to improve clinical trial design and efficiency through better patient stratification. The purpose of this narrative review is therefore to propose a guideline of clinically available MRI sequences and their derived neuroimaging biomarkers that have the potential to assess tissue damage at the macro- and microstructural level after SCI. In this piece, we make a recommendation for the use of key MRI sequences-both conventional and advanced-for clinical work-up and clinical trials.
Subjects: 6400 Life sciences research related to human health and disease > 6400 Life sciences research related to human health and disease
Department: Institut de génie biomédical
Research Center: NeuroPoly - Laboratoire de Recherche en Neuroimagerie
Funders: European Union’s Horizon 2020 research and innovation program, Swiss State Secretariat for Education and Research and Inno- vation (SERI), Wings for life INSPIRED, Swiss National Science foundation, UK MS Society, ISRT, Craig H. Neilsen Foundation, National Institute for Health Research University College London Hospitals Biomedical Research Centre
Grant number: No.-681094, Education and Research and Innovation (SERI) under contract number 15.0137, 181362/Eccellenza, No. 077, No 634541, 091593/Z/10/Z
PolyPublie URL: https://publications.polymtl.ca/5130/
Journal Title: Spinal Cord (vol. 57, no. 9)
Publisher: Springer Nature
DOI: 10.1038/s41393-019-0309-x
Official URL: https://doi.org/10.1038/s41393-019-0309-x
Date Deposited: 13 Jul 2022 10:50
Last Modified: 11 Nov 2022 14:00
Cite in APA 7: Seif, M., Gandini Wheeler-Kingshott, C. A. M., Cohen-Adad, J., Flanders, A. E., & Freund, P. (2019). Guidelines for the conduct of clinical trials in spinal cord injury: Neuroimaging biomarkers. Spinal Cord, 57(9), 717-728. https://doi.org/10.1038/s41393-019-0309-x

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