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

NCT ID: NCT06094166

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Degenerative Cervical Spinal Myelopathy Cervical Spinal Cord Compression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NMDCC

non-myelopathic cervical spinal cord compression

MRI

Intervention Type DIAGNOSTIC_TEST

Quantitative imaging MR parameters

healthy controls

subjects with no MR signs of cervical spinal cord compression

MRI

Intervention Type DIAGNOSTIC_TEST

Quantitative imaging MR parameters

Interventions

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MRI

Quantitative imaging MR parameters

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Palacky University

OTHER

Sponsor Role collaborator

Masaryk University

OTHER

Sponsor Role lead

Responsible Party

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Tomáš Horák

prof. MUDr. Josef Bednarik, CSc., FCMA, FEAN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Josef Bednarik, Prof. MD.

Role: PRINCIPAL_INVESTIGATOR

Masaryk University

Locations

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Faculty of Medicine, Masaryk University, Brno

Brno, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Tomas Horak, MD. PhD.

Role: CONTACT

+420724273734

Facility Contacts

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Tomas Horak, MD

Role: primary

+420724273734

Other Identifiers

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66138

Identifier Type: -

Identifier Source: org_study_id

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