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临床试验/NCT05242666
NCT05242666招募中不适用

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

Cambridge University Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Modified Japanese Orthopaedics Association (mJOA)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Modified Japanese Orthopaedics Association (mJOA)

时间窗: 6 Months Post Surgery

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Benjamin Davies

Honorary Specialist Registrar, Department of Neurosurgery, Cambridge University Hospital

Cambridge University Hospitals NHS Foundation Trust

研究点 (2)

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