Clinical Trials Directory

Trials / Completed

CompletedNCT03886610

Association of Quantitative and Functional Imaging With Clinical Outcome After Spinal Cord Injury

Quantitative and Functional Longitudinal Multimodal Imaging of the Brain and Cervical Spinal Cord in Spinal Cord Injury: Correlation With Clinical Outcome

Status
Completed
Phase
Study type
Observational
Enrollment
57 (actual)
Sponsor
Swiss Paraplegic Research, Nottwil · Network
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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

Conditions

Interventions

TypeNameDescription
OTHERHealthy controlsindividuals without spinal cord injury
OTHERSubacute SCI patientsindividuals with spinal cord injury ≥ 2 weeks
OTHERChronic SCI patientsindividuals with spinal cord injury ≥ 24 months

Timeline

Start date
2019-03-27
Primary completion
2022-12-31
Completion
2022-12-31
First posted
2019-03-22
Last updated
2023-03-13

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT03886610. Inclusion in this directory is not an endorsement.