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

Seif, M., Wheeler-Kingshott, C. A. M. G., 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. doi:10.1038/s41393-019-0309-x.

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Item Permalink: https://hdl.handle.net/21.11116/0000-0004-50A5-7 Version Permalink: https://hdl.handle.net/21.11116/0000-0005-4EAA-5
Genre: Journal Article

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 Creators:
Seif, Maryam1, Author
Wheeler-Kingshott, Claudia A. M. Gandini2, 3, 4, Author
Cohen-Adad, Julien5, Author
Flanders, Adam E.6, Author
Freund, Patrick1, 2, 7, 8, Author           
Affiliations:
1Balgrist Spinal Cord Injury Center, Balgrist University Hospital, Zurich, Switzerland, ou_persistent22              
2UCL Queen Square Institute of Neurology, University College London, United Kingdom, ou_persistent22              
3Department of Brain and Behavioral Sciences, University of Pavia, Italy, ou_persistent22              
4Institute for Advanced Studies of Pavia, Italy, ou_persistent22              
5NeuroPoly Lab, Institute of Biomedical Engineering, École Polytechnique de Montréal, QC, Canada, ou_persistent22              
6Department of Radiology, Regional Spinal Cord Injury Center of the Delaware Valley, Thomas Jefferson University, Philadelphia, PA, USA, ou_persistent22              
7Department Neurophysics (Weiskopf), MPI for Human Cognitive and Brain Sciences, Max Planck Society, ou_2205649              
8Department of Neurology, University Hospital Zurich, Switzerland, ou_persistent22              

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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.

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Language(s): eng - English
 Dates: 2019-05-202019-03-152019-05-212019-07-022019-09
 Publication Status: Issued
 Pages: -
 Publishing info: -
 Table of Contents: -
 Rev. Type: Peer
 Identifiers: DOI: 10.1038/s41393-019-0309-x
Other: Epub 2019
PMID: 31267015
 Degree: -

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Project name : Antibodies against Nogo-A to enhance plasticity, regeneration and functional recovery after acute spinal cord injury, a multicenter European clinical proof of concept trial / NISCI
Grant ID : 681094
Funding program : Horizon 2020
Funding organization : European Commission (EC)
Project name : -
Grant ID : 15.0137
Funding program : -
Funding organization : Swiss State Secretariat for Education, Research and Innovation (SERI)
Project name : -
Grant ID : WFL-CH-007/14
Funding program : -
Funding organization : Wings for Life, Austria
Project name : -
Grant ID : 181362
Funding program : Eccellenza fellowship
Funding organization : Swiss National Science Foundation
Project name : -
Grant ID : 077
Funding program : -
Funding organization : UK MS Society
Project name : -
Grant ID : -
Funding program : -
Funding organization : Wings for Life and Craig H. Neilsen Foundation
Project name : A Clinical Decision Support system based on Quantitative multimodal brain MRI for personalized treatment in neurological and psychiatric disorders / CDS-QUAMRI
Grant ID : 634541
Funding program : Horizon 2020
Funding organization : European Commission (EC)
Project name : -
Grant ID : -
Funding program : -
Funding organization : National Institute for Health Research University College London Hospitals Biomedical Research Centre
Project name : -
Grant ID : 091593/Z/10/Z
Funding program : -
Funding organization : Wellcome Trust

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Title: Spinal Cord
Source Genre: Journal
 Creator(s):
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Publ. Info: Basingstoke : Nature Publishing Group
Pages: - Volume / Issue: 57 (9) Sequence Number: - Start / End Page: 717 - 728 Identifier: ISSN: 1362-4393
CoNE: https://pure.mpg.de/cone/journals/resource/1362-4393