An observational study in Degenerative Cervical Spinal Myelopathy and Cervical Spinal Cord Compression, sponsored by Masaryk University. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Masaryk University · Observational
Quantitative Magnetic Resonance Imaging Parameters as Predictors of Outcome for Non-Myelopathic Degenerative Cervical Cord Compression: A Longitudinal Study
The study uses semi-automated detection of anatomical metrics (morphometric parameters) and DCC with Spinal Cord Toolbox (SCT). This method have been proven more reliable than expert's manual rating, the introduction of the automated method will be utilized in the future multi-centre and longitudinal studies. Routine anatomical morphometric parameters such as compressive ratio (CR) and cross-sectional area (CSA) will be acquired along with microstructural and metabolic metrics obtained with validated dMRI and MRS methods, remote cervical cord atrophy from voxel-based MRI volumetry, T2* white matter/gray matter (WM/GM) signal-intensity ratio, and also metrics obtained with novel Intravoxel Incoherent Motion (IVIM) method will predict progression of NMDCC into symptomatic DCM. "Natural course" (i.e., speed of progression) of the severity of DCC assessed with anatomical and advanced MRI/MRS metrics is not known but may play a role in the progression from NMDCC to symptomatic DCM. Aims of this project are: To determine independent predictors of unfavourable outcome - progression into symptomatic degenerative cervical myelopathy (DCM) - among quantitative MRI parameters and compare them with already defined clinical and electrophysiological predictors. To evaluate the "natural course" of MRI descriptors of compression and its severity, and the correlation between progression and development of symptomatic DCM. To implement automated detection of cervical cord compression using Spinal Cord Toolbox based on automatically computed morphometric parameters.
52 studies on the registry are indexed under Spinal Cord Compression; 19 are open to participants now.
This study's planned enrollment of 160 is above the median of 70 across 17 observational studies indexed under Spinal Cord Compression.
Browse Spinal Cord Compression studies →Masaryk University is the lead sponsor of 47 studies on the registry; 20 are open to participants now.
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Healthy controls and patients with non-myelopathic cervical spinal cord compression (NMDC)
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Subject with no to MR examination. Clinically asymptomatic cervical spinal cord compression or subjects with no spinal cord compression.
Exclusion Criteria:
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Contraindication
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non-myelopathic cervical spinal cord compression
Diagnostic Test: MRI
subjects with no MR signs of cervical spinal cord compression
Diagnostic Test: MRI
Quantitative imaging MR parameters
Anatomical MRI metrics
compressive ratio (CR)
Time frame: 45 minutes
Anatomical MRI metrics
cross-sectional area (CSA)
Time frame: 45 minutes
dMRI: signs of microstructural myelopathy
fractional anisotropy
Time frame: 45 minutes
MRS: signs of metabolic myelopathy (above the level of compression)
Myo-ins/NAA ratio
Time frame: 45 minutes
Voxel-based MRI volumetry (remote spinal cord atrophy above the compression level)
remote cervical cord atrophy
Time frame: 45 minutes
IVIM and T2*WM/GM signal-intensity ratio
Intravoxel incoherent motion detection
Time frame: 45 minutes
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2022 (actual). Primary completion is estimated for Dec 2025, 43 months after the start.
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