Status:
ACTIVE_NOT_RECRUITING
Quantitative Imaging of Cervical Spinal Structures - the DISC Pilot Study -
Lead Sponsor:
University Medical Center Groningen
Conditions:
Cervical Radiculopathy
Cervical Myelopathy
Eligibility:
All Genders
18+ years
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...
Detailed Description
RATIONALE: Cervical degenerative disc disease (CDDD) is the consequence of degeneration of intervertebral discs and joints and can result in compression of the cervical nerve root leading to clinical...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
July 26 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06610175
Start Date
July 26 2024
End Date
August 1 2026
Last Update
May 6 2025
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands