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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
| Wolfson Brain Imaging Centre | UNKNOWN |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCM1: MRI Spinal Cord | Other | 3T MR Imaging of the cervical spinal cord, before and at 3-6 months after surgery. |
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| DCM2: MRI Brain and Spinal Cord | Other | 3T MR Imaging of the brain and cervical spinal cord, before and at 3-6 months after surgery. A subset will also be invited to undergo 7T MRI Brain and Spinal Cord Imaging. |
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| DCM3: [11C]-PIB MR/PET Cervical Spinal Cord | Other | [11C]PIB PET/MR Imaging of the cervical spinal cord, before and at 3-6 months after surgery. |
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| Healthy Volunteer: MRI Brain and Spinal Cord | Other | Age-Matched Healthy Controls will undergo MRI Brain and Spinal Cord. A subset will also be invited to undergo interval imaging at 3-6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3T MR Imaging of the cervical spinal cord | Diagnostic Test | Patients will undergo either Magnetic Resonance Imaging of the Spinal Cord |
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| Measure | Description | Time Frame |
|---|---|---|
| Modified Japanese Orthopaedics Association (mJOA) | 6 Months Post Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Short-Form 36 (SF-36) | Quality of Life (0-100, where 50 is normal for geographical population. Higher score is better) | Routine Clinical Care: Baseline and 3-6 Months Post-Operatively |
| Numeric Rating Scale (NRS) Pain |
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Inclusion Criteria
Exclusion Criteria
The participant may not enter the study if ANY of the following apply:
Participant unable to give informed consent;
Participant unable to undergo, or intolerant of MR or PET/MR imaging
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.
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):
Exclusion Criteria Specific for PET/MR Imaging Stream
In addition, the following exclusion criteria will apply for PET imaging, to reduce implications of exposure to ionising radiation, or interpretation of findings.
4.3.2 Volunteers
Inclusion Criteria
The participant may not enter the study if ANY of the following apply:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Davies | Contact | 01223 254517 | benjamin.davies4@nhs.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cambridge University Hospital | Recruiting | Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29472200 | Background | Davies BM, Mowforth OD, Smith EK, Kotter MR. Degenerative cervical myelopathy. BMJ. 2018 Feb 22;360:k186. doi: 10.1136/bmj.k186. No abstract available. |
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Annoymised Data will be made available, for collaboration, at the discretion of the senior investigators upon completion of the study.
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Observational study of patients undergoing surgery for degenerative cervical myelopathy, allocated to receive an additional form of imaging assessment before and after surgery.
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| Positron Emission Tomography using [11C]PIB | Other | Patients will undergo combination MRI/PET using a [11C]PIB radiotracer |
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| 3T MR Imaging of the Brain | Other | 3T MR Imaging of the Brain |
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| 7T MR Imaging of the Spinal Cord | Other | 7T MR Imaging of the Spinal Cord |
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Pain Score (0-10, where 10 is maximum pain, and 0 is no pain. Lower score is better)
| Routine Clinical Care: Baseline and 3-6 Months Post-Operatively |
| Myelopathy.org Symptom Inventory [MOSI] | 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). | Routine Clinical Care: Baseline and 3-6 Months Post-Operatively |
| Neurological Exam | Routine Neurological Exam (Motor and Sensory changes to hands, arms and legs, long-tract signs in cluded reflexes, Hoffman's and Babbinski's reflexes) | Routine Clinical Care: Baseline and 3-6 Months Post-Operatively |
| ID | Term |
|---|---|
| C475519 | 2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole |
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