Swiss Paraplegic Centre
Nottwil, 6207, Switzerland
NCT Number: NCT03886610
The overall study aim is to provide additional magnetic resonance imaging parameters of the cervical spinal cord, brainstem and brain and a better understanding of changes after spinal cord injury (SCI) and to define new magnetic resonance (MR) biomarkers to correlate with sensomotoric functioning and clinical outcome.
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Notify Me18 year–80 year
All sexes
Observational
Nottwil, 6207, Switzerland
Injury of the spinal cord, for instance induced by trauma, is complex involving primary mechanisms caused by forces directly affecting the spinal cord and secondary mechanisms consisting of complex physiological processes after trauma.
Conventional magnetic resonance imaging (MRI) is the current standard to assess morphologic changes of the spinal cord after injury. However, conventional MRI provides little information regarding the health and integrity of the brain and spinal cord tissue itself, due to the fact that signal intensity changes are non-specific and do not correspond directly with physiological processes. This is reflected in the poor correlation of conventional MRI data with neurological and functional impairment in various spinal cord pathologies (such as multiple sclerosis compression myelopathy) and failure to provide reliable prognostic information.
By applying a combination of diffusion weighted imaging, functional MRI and magnetic resonance spectroscopy will give us a better understanding of the changes after injury of the cervical spinal cord, brainstem and brain. Correlating the imaging data with the neurological and clinical status of patients could improve the patient status prediction and therapy planning.
This study is divided into three sub-projects:
i) Reproducibility study of the MR measurements in healthy controls ii) Progression of MR biomarkers in subacute patients with SCI and comparison to chronic patients with SCI iii) Prediction of clinical outcome based on MR biomarkers
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Healthy controls:
Inclusion criteria
Exclusion criteria
Subacute and chronic patients with spinal cord injury:
Inclusion criteria
Exclusion criteria
individuals without spinal cord injury
individuals with spinal cord injury ≥ 2 weeks
individuals with spinal cord injury ≥ 24 months
Time frame: 16-40 days after injury, 70-96 days after injury, 150- 186 days after injury
Degree of anisotropy of a diffusion process (value between zero and one). A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. FA is a measure often used in diffusion imaging where it is thought to reflect fiber density, axonal diameter, and myelination in white matter.
Time frame: 16-40 days after injury, 70-96 days after injury, 150- 186 days after injury
Measurement of the magnitude of diffusion (of water molecules) within tissue
Time frame: 16-40 days after injury, 70-96 days after injury, 150- 186 days after injury
Measurement of the relative diffusion (of water molecules) within tissue
Swiss Paraplegic Research, Nottwil
Network
Quantitative and Functional Longitudinal Multimodal Imaging of the Brain and Cervical Spinal Cord in Spinal Cord Injury: Correlation With Clinical Outcome
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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