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Clinical Trials/NCT05242666
NCT05242666
Recruiting
Not Applicable

Evaluating Advanced Imaging Techniques for Use in the Assessment of Degenerative Cervical Myelopathy

Cambridge University Hospitals NHS Foundation Trust1 site in 1 country100 target enrollmentApril 17, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical Spondylosis With Myelopathy
Sponsor
Cambridge University Hospitals NHS Foundation Trust
Enrollment
100
Locations
1
Primary Endpoint
Modified Japanese Orthopaedics Association (mJOA)
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 17, 2021
End Date
February 1, 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Benjamin Davies

Honorary Specialist Registrar, Department of Neurosurgery, Cambridge University Hospital

Cambridge University Hospitals NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Modified Japanese Orthopaedics Association (mJOA)

Time Frame: 6 Months Post Surgery

Secondary Outcomes

  • Short-Form 36 (SF-36)(Routine Clinical Care: Baseline and 3-6 Months Post-Operatively)
  • Myelopathy.org Symptom Inventory [MOSI](Routine Clinical Care: Baseline and 3-6 Months Post-Operatively)
  • Numeric Rating Scale (NRS) Pain(Routine Clinical Care: Baseline and 3-6 Months Post-Operatively)
  • Neurological Exam(Routine Clinical Care: Baseline and 3-6 Months Post-Operatively)

Study Sites (1)

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