Quantitative MR Parameters in Non-myelopathic Degenerative Cervical Spinal Cord Compression: a Longitudinal Study.

Recruiting

• Conditions: Degenerative Cervical Spinal Myelopathy; Cervical Spinal Cord Compression
• Interventions: Diagnostic Test: MRI

• Registration Number: NCT06094166
• Lead Sponsor: Masaryk University

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.

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2023-09-12
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-16
• Last Update Submitted: 2023-10-16
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NMDCC	MRI	non-myelopathic cervical spinal cord compression
healthy controls	MRI	subjects with no MR signs of cervical spinal cord compression

Primary Outcome Measures

Name	Time	Method
dMRI: signs of microstructural myelopathy	45 minutes	fractional anisotropy
MRS: signs of metabolic myelopathy (above the level of compression)	45 minutes	Myo-ins/NAA ratio
Anatomical MRI metrics	45 minutes	cross-sectional area (CSA)
Voxel-based MRI volumetry (remote spinal cord atrophy above the compression level)	45 minutes	remote cervical cord atrophy

Secondary Outcome Measures

Name	Time	Method
IVIM and T2*WM/GM signal-intensity ratio	45 minutes	Intravoxel incoherent motion detection

Trial Locations

Locations (1)

Faculty of Medicine, Masaryk University, Brno; 🇨🇿 Brno, Czechia