Cervical Spondylosis With Myelopathy, Degenerative Cervical Myelopathy
Conditions
Keywords
Positron Emission Tomography, Magnetic Resonance Imaging
Brief summary
To use advanced imaging techniques, including MRI Brain and Spinal Cord, and MRI/PET Spinal Cord to provide an assessment of Degenerative Cervical Myelopathy to improve understanding of the pathophysiology and natural history of DCM.
Detailed description
Degenerative Cervical Myelopathy (DCM) is a disabling condition affecting up to 2% of adults. It arises when arthritic changes in the cervical spine compress and injure the spinal cord, causing progressive loss of bodily function. Surgery will remove compression and stop injury. However, for a full recovery, it must occur before irreversible spinal cord damage. Current assessments cannot provide this information and today, 95% of patients are left disabled: an assessment that measures spinal cord damage would change this tomorrow. Imaging advances, well established for measuring disease of the brain, have the potential to provide this in DCM, but requires further investigation. This is the subject of this proposed application: specifically, to investigate 3 different but promising imaging approaches for the assessment of DCM: 1. Advanced magnetic resonance imaging (MRI) to image within the spinal cord 2. Advanced MRI to measure the changes that occur within the brain following DCM 3. Positron Emission Tomography (PET) to measure the active disease biology within the spinal cord. Individuals with a diagnosis of DCM, will be invited to undergo one of these options, before and after their surgical treatment. Clinical measures used in routine practice will be noted, in order to draw comparisons with imaging. A healthy control group will also be used for MRI imaging, in order to identify changes specific to DCM. Aside from the additional imaging, there will be no changes in routine care.
Interventions
DIAGNOSTIC_TEST3T MR Imaging of the cervical spinal cord
Patients will undergo either Magnetic Resonance Imaging of the Spinal Cord
OTHERPositron Emission Tomography using [11C]PIB
Patients will undergo combination MRI/PET using a \[11C\]PIB radiotracer
OTHER3T MR Imaging of the Brain
3T MR Imaging of the Brain
OTHER7T MR Imaging of the Spinal Cord
7T MR Imaging of the Spinal Cord
Sponsors
National Institute for Health Research, United Kingdom
Wolfson Brain Imaging Centre
Cambridge University Hospitals NHS Foundation Trust
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Observational study of patients undergoing surgery for degenerative cervical myelopathy, allocated to receive an additional form of imaging assessment before and after surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Participant has a diagnosis of DCM, based on a combination of symptoms, signs and conventional MRI findings (Table 2) 2. Participant is scheduled for surgical treatment for DCM 3. Participant is willing and able to give informed consent for participation in the study; 4. Male or Female, aged 18 - 85 years (inclusive);
Exclusion criteria
The participant may not enter the study if ANY of the following apply: 1. Participant unable to give informed consent; 2. Participant unable to undergo, or intolerant of MR or PET/MR imaging 3. Participant has co-existing or prior neurological disease of the brain, spinal cord, or peripheral nervous system, including but not limited to, Lumbar Canal Stenosis, Multiple Sclerosis, Dementia and Parkinson's Disease. 4. Contraindications to MRI: These are chiefly the presence of metallic implants that are not known to be MR safe, particularly in terms of movement or substantial heating. Devices that may need to be considered in this context include (this is not an exhaustive list, and this issue will be considered on a case-by-case basis for any implant or external fixation device): * Cerebral aneurysm clips not known to be MR safe * Intra-ocular metallic shards * Cochlear implants * Automatic cardioverter defibrillators * Nerve stimulation units * Other electronic implants, such as cardiac pacemakers * Orthopedic external fixations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Japanese Orthopaedics Association (mJOA) | 6 Months Post Surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-Form 36 (SF-36) | Routine Clinical Care: Baseline and 3-6 Months Post-Operatively | Quality of Life (0-100, where 50 is normal for geographical population. Higher score is better) |
| Numeric Rating Scale (NRS) Pain | Routine Clinical Care: Baseline and 3-6 Months Post-Operatively | Pain Score (0-10, where 10 is maximum pain, and 0 is no pain. Lower score is better) |
| Myelopathy.org Symptom Inventory [MOSI] | Routine Clinical Care: Baseline and 3-6 Months Post-Operatively | Quality of Life and Disease Specific Measure (Range of Myelopathy symptoms are scored as Not present, on an intensity scale of 0 to 10, where 10 is worse). |
| Neurological Exam | Routine Clinical Care: Baseline and 3-6 Months Post-Operatively | Routine Neurological Exam (Motor and Sensory changes to hands, arms and legs, long-tract signs in cluded reflexes, Hoffman's and Babbinski's reflexes) |
Countries
United Kingdom
Contacts
Primary ContactBenjamin Davies
Outcome results
None listed