Quantitative Imaging of Cervical Spinal Structures - the DISC Pilot Study -

NCT06610175 | Active Not Recruiting

• 1 other identifier: 16948
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to explore a multi-parametric quantitative MRI approach to measure cervical intervertebral discs, the spinal cord and its nerve roots in healthy participants and patients with cervical degenerative disc disease (CDDD). CDDD is the consequence of degeneration of intervertebral discs and joints leading to symptoms of cervical radiculopathy, myelopathy, or a combination of both. The incidence of symptomatic CDDD is rising with the aging population, and, consequently, a significant increase in surgeries for symptomatic CDDD is predicted in the upcoming years. However, the decision for- and optimal timing of surgery remain challenging. Currently, the decision for surgery in patients with symptomatic CDDD is related to symptoms, as well as position and size of disc herniation on conventional Magnetic Resonance Imaging (MRI). However, conventional MRI only enables qualitative morphological evaluation, leaving space for subjective individual interpretation. Also, disc herniations on conventional MRI are frequently found in asymptomatic individuals, while, in symptomatic individuals type and extent of disc herniation does not correlate to severity of symptoms. Altogether, the current standard using conventional MRI cannot optimally predict response to surgery for patients with symptomatic CDDD. The primary aim of this project is to investigate whether a combination of different quantitative imaging sequences can provide more detailed information on disc herniation related compression and potentially aid in determining more objective cut-offs to stage disc herniation in patients with symptomatic CDDD, as well as to analyze whether differences exist in quantitative imaging parameters of discs in healthy participants versus patients with symptomatic CDDD. These novel techniques are promising, as they are noninvasive and could potentially aid in determining objective cut-offs to stage disc herniation. Since no single measurement has been proven to be the golden standard in previous studies, it is likely that a combination of measurements is needed for clinical application

Conditions

Cervical Radiculopathy; Cervical Myelopathy

Outcome Measures

Primary Outcomes (4)

• Quantitative MRI sequences

  Technical feasibility and repeatibility of quantitative MRI sequences (i.e. z-DTI, ASL, DSC, DCE, SyMRI, and TMRE) of cervical spinal structures (i.e. intervertebral disc, spinal cord, and nerve roots) in healthy participants and patients with symptomatic CDDD.

  MRI conducted at study visit (baseline)

• Clinical correlation of quantitative MRI sequences and clinical impairment in patients with symptomatic CDDD

  To determine a correlation of quantitative MRI sequences of cervical spinal structures to clinical impairment in patients with symptomatic CDDD. Clinical impairment will be measured with the Neck Disability Index (NDI) for cervical radiculopathy, modified Japanese Orthopaedic Association Score (mJOA) for cervical myelopathy, and NDI as well as mJOA for cervical radiculomyelopathy.

  MRI and clinical examinations conducted at study visit (baseline)

• To determine a correlation between baseline quantitative MRI sequences of cervical spinal structures and surgical treatment after 6 months of follow-up in patients with symptomatic CDDD as well as clinical outcomes assessed at 6 months of follow-up.

  6 months

• Comparison CSI

  To make a comparison of the CSI-score in healthy participants with bulging discs on MRI compared to patients with symptomatic CDDD.

  During first study visit

Secondary Outcomes (4)

• Correlation between quantitative MRI sequences of the cervical spinal cord with extent of compression on anatomical MRI (cross-sectional area spinal cord) in healthy participants and patients with symptomatic CDDD.

  Comparison made at baseline and for patients with symptomatic CDDD also at 6 months follow-up

• Between-group analyses comparing quantitative MRI sequences of cervical spinal structures of healthy participants to subgroups of patients

  MRI conducted at baseline and at 6 months follow-up in the patients with symptomatic CDDD

• Comparison of quantitative MRI sequences of cervical spinal structures in healthy participants and patients with symptomatic CDDD to available values in literature.

  Assessed during study visit

• To determine a correlation of quantitative MRI sequences of cervical spinal structures to clinical outcomes

  MRI conducted at baseline and at 6 months follow-up in the patients with symptomatic CDDD

Study Arms (2)

Healthy participants

Device: Quantitative MRI and anatomical MRI

Patients with CDDD

Device: Quantitative MRI and anatomical MRI

Interventions

Quantitative MRI and anatomical MRI DEVICE

The total scanning time will be approximately 40 minutes. Additionally, 10 healthy participants and 10 patients with symptomatic CDDD will undergo a second MRI with additional sequences for assessment of reproducibility on another day/time. Also: included participants will undergo neurologic examination and fill out questionnaires for NDI, VAS-arm, VAS-neck, WA-SI, EQ-5D-5L, CSI, mJOA and Nurick.

Also known as: zoomed-DTI, Arterial Spin Labelling (ASL), Diffusion Susceptibility Contrast (DSC), Dynamic Contrast Enhanced (DCE), Synthethic MRI (SyMRI), Tomo-MR-Elastography (TMRE)

Healthy participants; Patients with CDDD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy participants and patients with symptomatic CDDD with an appointment at the neurosurgical outpatient clinic will be asked to participate in this study.

You may qualify if:

• Patients with symptomatic CDDD
• Age ≥18 years
• One-level or 2-level symptomatic CDDD (radiculopathy, myelopathy or radiculomyelopathy) of cervical levels C4-5, C5-6l, C6-7 or C7-Th1.
• 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.
• Women who use anticonception or are in their menopause. If this is not the case, a negative pregnancy test is necessary.
• Healthy participants
• Age-matched healthy participant.
• 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.
• Women who use anticonception or are in their menopause. If this is not the case, a negative pregnancy test is necessary

You may not qualify if:

• Patients with symptomatic CDDD
• Multi-segmental (3 or more segments) symptomatic CDDD.
• Contraindication for an MRI scan (e.g. implanted non-MRI-compatible devices or foreign bodies, claustrophobic or pregnancy).
• A positive pregnancy test.
• Allergy for contrast medium.
• Previous history of cervical spine surgery.
• Healthy participants
• Contraindication for an MRI scan (e.g. implanted non-MRI-compatible devices or foreign bodies, claustrophobic or pregnancy).
• A positive pregnancy test.
• Allergy for contrast medium.
• Previous history of cervical spine surgery.
• Complaints of symptomatic CDDD (radiating arm/neck pain, tingling fingers, loss of strength or changed sensibility in one of the upper extremities).

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Jos Kuijlen, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: September 24, 2024
• Study Start: July 26, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 6, 2025

Record last verified: 2024-05

Locations

NL (1)