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

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

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

Study Overview

• Status: Recruiting
• Conditions: Degenerative Cervical Spinal Myelopathy; Cervical Spinal Cord Compression
• Intervention / Treatment: Diagnostic test: MRI

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 Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Tomas Horak, MD. PhD.; Phone Number: +420724273734; Email: horak.tomas@fnbrno.cz

Study Locations

• Czechia
  • Brno, Czechia
    • Recruiting
    • Faculty of Medicine, Masaryk University, Brno
    • Contact: Tomas Horak, MD; Phone Number: +420724273734; Email: tomas.horak@fnbrno.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy controls and patients with non-myelopathic cervical spinal cord compression (NMDC)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NMDCC; non-myelopathic cervical spinal cord compression	Diagnostic test: MRI; Quantitative imaging MR parameters
healthy controls; subjects with no MR signs of cervical spinal cord compression	Diagnostic test: MRI; Quantitative imaging MR parameters

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IVIM and T2*WM/GM signal-intensity ratio	Intravoxel incoherent motion detection	45 minutes

Collaborators and Investigators

• Sponsor: Masaryk University
• Collaborators: Palacky University
• Investigators: Principal Investigator: Josef Bednarik, Prof. MD., Masaryk university

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Cord Injuries; Spinal Cord Diseases; Spinal Cord Compression; Spinal Osteophytosis
• Other Study ID Numbers: 66138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No