Cervical Degenerative Disc Disease Cervical Disc Herniation
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy participants and patients with Cervical Degenerative Disc Disease: -Patients with cervical degenerative disc disease aged >18 years and age-matched healthy participants. -Sufficient understanding of spoken and written Dutch language -Agrees to participate in the obligatory measurements of this study and signed informed consent prior to any study-related procedures. -No contraindication for an MRI scan (e.g. non-MRI compatible heart pacemaker, metallic foreign body in the eye, aneurysm clip in the brain, severe claustrophobia or known pregnancy).
Exclusion criteria
Exclusion criteria: -Patient refusal -Uncapable to read/understand written and spoken Dutch language -Contraindications for performing MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 - Z-DTI: Fractional anisotropy (FA-metric). - ASL: *M obtained after transit time (TI) for labelled and unlabelled arterial blood. - DSC: relative spinal cord blood volume (rSCBV), relative oxygen extraction fraction (rOEF), mean transit time (MTT), capillary-level hemodynamics (CTH), cerebral metabolic rate of oxygen (CMR2) arterial imput function (AIF). - DCE: transfer constant (k-trans), fractional volume of extravascular-extracellular space (Ve), fractional volume of plasma space (Vp), rate constant. - TMRE: stiffness and fluidity. - SyMRI: tissue properties T1, T2 and PD and dynamic contrast weighted images (T1W, T2W, PDW, STIR and FLAIR). Part 2 In addition to study parameters described in part 1, main study parameters of part 2 are clinical outcome measured with NDI, VAS-arm, VAS-neck, mJOA, Nurick, EQ-5D-5L and WAI-SI. Part 3 In addition to study parameters described in part 1 and 2, which will be repeated after 1 year of follow-up in part 3 in patients with symptomatic CDDD, also surgical treatment status and characteristics will be documented. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 -To determine a correlation of quantitative MRI sequences of the cervical spinal cord to extent of compression on conventional MRI in healthy participants and patients with symptomatic CDDD (comparison for the spinal cord only as nerve roots are difficult to measure on conventional MRI). Extent of compression on conventional MRI is measured as a ratio between the diameter of the spinal canal and spinal cord. -Compare quantitative MRI sequences of cervical spinal structures in healthy participants and patients with symptomatic CDDD to available values in literature. -To do a between-group analysis, comparing quantitative MRI sequences of cervical spinal structures of healthy participants to patients with symptomatic CDDD (as a whole group). -To do a between-group analysis, comparing quantitative MRI sequences of cervical nerve root and intervertebral disc of healthy participants to patients with cervical radiculopathy (as a subgroup of symptomatic CDDD patients). -To do a between-group analysis, comparing quantitative MRI sequences of cervical spinal cord and intervertebral disc of healthy participants to patients with cervical myelopathy (as a subgroup of symptomatic CDDD patients). Part 2 -To determine a correlation of quantitative MRI sequences of cervical spinal structures to clinical outcome measured with Visual Analogue Scale (VAS)-arm, VAS-neck, Nurick grade, EuroQol 5-Dimension 5-Level (EQ-5D-5L), and Work Ability Single item (WA-SI) in patients with symptomatic CDDD. Evaluating a correlation of quantitative MRI parameters to clinical measurements other than the primary outcomes NDI and mJOA will serve as a test of robustness of the primary outcomes. Part 3 -To determine correlation of baseline quantitative MRI sequences of cervical spinal structures to clinical outcome measured after 6 months of follow-up (NDI, VAS-arm, VAS-neck, EQ-5D-5L, WA-SI, mJOA or Nurick) in patients with symptomatic CDDD accordingly. -To compare | — |
Countries
Netherlands
Outcome results
None listed