Association of Quantitative and Functional Imaging With Clinical Outcome After Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT03886610|
Recruitment Status : Not yet recruiting
First Posted : March 22, 2019
Last Update Posted : March 22, 2019
|Condition or disease||Intervention/treatment|
|Spinal Cord Injuries||Other: Healthy controls Other: Subacute SCI patients Other: Chronic SCI patients|
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
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Quantitative and Functional Longitudinal Multimodal Imaging of the Brain and Cervical Spinal Cord in Spinal Cord Injury: Correlation With Clinical Outcome|
|Estimated Study Start Date :||April 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Individuals without spinal cord injury
Other: Healthy controls
individuals without spinal cord injury
Subacute SCI patients
Subacute patients with spinal cord injury (duration >2 weeks)
Other: Subacute SCI patients
individuals with spinal cord injury ≥ 2 weeks
Chronic SCI patients
Patients with chronic spinal cord injury (duration ≥24 months)
Other: Chronic SCI patients
individuals with spinal cord injury ≥ 24 months
- Change in Fractional Anisotropy (FA) [ 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.
- Change in Apparent Diffusion Coefficient (ADC) [ 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
- Change in Relative Anisotropy (RA) [ 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886610
|Contact: Ernst Christiaanse, MDfirstname.lastname@example.org|
|Principal Investigator:||Ernst Christiaanse, MD||Swiss Paraplegic Centre|