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

NCT06610175 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-05-06

No results posted yet for this study

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

Interventions

DEVICE

Quantitative MRI and anatomical MRI

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.

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Jos Kuijlen, MD PhD · University Medical Center Groningen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-26
Primary Completion
2026-01-31
Completion
2026-08-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06610175 on ClinicalTrials.gov