Predictive Value of Diffusion MRI in Cervical Spondylotic Myelopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Accurate prediction of neurologic outcomes after surgery
研究概览
简要总结
Patients who have been diagnosed with Cervical Spondylotic Myelopathy will be asked to undergo an MRI using diffusion basis spectrum imaging (DBSI) technology. The patients will have this MRI preoperatively and at 24 months postop. The investigators believe that with this imaging, biomarkers will be able to be seen to assist in prediction of long term outcomes in patients with spinal cord compression. These patients will be compared to healthy cohorts who will also undergo an MRI using the DBSI technology.
详细描述
CSM is the most common form of spinal cord injury and is the leading cause of progressive disability in patients over the age of 65. A major shortcoming limiting the clinical management of CSM is the lack of quantifiable metrics to 1) base clinical decisions and 2) predict potential for functional recovery following surgical intervention. DBSI MRI will provide imaging biomarkers to more reliably predict a patient's clinical course, response to therapy, and long-term prognosis.
Patients who are diagnosed with CSM will have an MRI using the DBSI technology preoperatively and at 24 months. Surgical patients will be assessed with the Neck Disability Index (NDI), Disability of the Arm, Shoulder and Hand (DASH), hand grip dynamometer and Manual Muscle Testing (MMT), the modified Japanese Orthopaedic Association scale (mJOA), and the Major Depression Inventory (MDI), the Short Form-36 (SF-36) and Nurick scoring.
A control group of healthy volunteers will have an MRI using the DBSI technology when enrolled and then again between 12-24 months later.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of ongoing spinal cord compression,
- •clinical evidence of CSM as determined by signs and symptoms including, but not limited to loss of manual dexterity, extremity weakness, sensory abnormalities, quadriparesis, loss of proprioception, and positive Babinski's or Hoffman's sign.
排除标准
- •having an MRI incompatible device
- •having a known diagnosis of amyotrophic lateral sclerosis, multiple sclerosis, rheumatoid arthritis, concomitant thoracic and/or lumbar stenosis, spine tumor or HIV-related myelopathy and having systemic instability or being deemed unable to tolerate standard MRI sequencing.
研究组 & 干预措施
Investigational subjects
Patients who have been diagnosed with cervical spondylotic myelopathy and who will be undergoing surgical correction for this diagnosis.
Visit 1 Investigational subjects will undergo a clinical assessment. Patients will undergo a DBSI MRI
Visit 2. 6 months after surgery, investigational subjects will undergo a clinical assessment.
Visit 3 12 months after surgery, investigational subjects will undergo a clinical assessment
Visit 4 18 months after surgery, investigational subjects will undergo a clinical assessment.
Visit 5 24 months after surgery, investigational subjects will undergo a clinical assessment and a DBSI MRI.
干预措施: MRI with DBSI technology (Diagnostic Test)
Control group
Healthy volunteers aged 45-65 Visit 1: DBSI MRI Visit 2: 24 months after first MRI, patient will undergo the second MRI
干预措施: MRI with DBSI technology (Diagnostic Test)
结局指标
主要结局
Accurate prediction of neurologic outcomes after surgery
时间窗: 24 months
Outcome measure will assess spinal cord DBSI pathological metrics at baseline and at 24 months.
次要结局
- Assessment of effects of blood flow deficits on spinal cord pathology(24 months)
研究者
Wilson Z. Ray
Principal Investigator
Washington University School of Medicine