Clinical trial NCT06094166: Quantitative MR Parameters in Non-myelopathic Degenerative Cervical Spinal Cord Compression: a Longitudinal Study.
Official title: Quantitative Magnetic Resonance Imaging Parameters as Predictors of Outcome for Non-Myelopathic Degenerative Cervical Cord Compression: A Longitudinal Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Degenerative Cervical Spinal Myelopathy
Cervical Spinal Cord Compression
Lead sponsor: Masaryk University
Sponsor class: OTHER
Collaborators: name: Palacky University
First posted: 2023-10-23
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy controls and patients with non-myelopathic cervical spinal cord compression (NMDC)

Brief summary: Quantitative Magnetic Resonance Imaging Parameters as Predictors of Outcome for Non-Myelopathic Degenerative Cervical Cord Compression: A Longitudinal Study

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Subject with no contraindication to MR examination. Clinically asymptomatic cervical spinal cord compression or subjects with no spinal cord compression.

Exclusion Criteria:

* A subject will be excluded if he/she has a contraindication to MR scanning implanted metal clips or wires of the type which may concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field.
* Pregnancy
* Claustrophobia

Primary outcomes:
measure: Anatomical MRI metrics
timeFrame: 45 minutes
measure: Anatomical MRI metrics
timeFrame: 45 minutes
measure: dMRI: signs of microstructural myelopathy
timeFrame: 45 minutes
measure: MRS: signs of metabolic myelopathy (above the level of compression)
timeFrame: 45 minutes
measure: Voxel-based MRI volumetry (remote spinal cord atrophy above the compression level)
timeFrame: 45 minutes
Secondary outcomes:
measure: IVIM and T2*WM/GM signal-intensity ratio
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Faculty of Medicine, Masaryk University, Brno
Study officials:
affiliation: Masaryk University
name: Josef Bednarik, Prof. MD.
role: PRINCIPAL_INVESTIGATOR
References: