The Second Affiliated Hospital of Nantong University, Nantong First People's Hospital, Nantong University
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- MRI image
研究概览
简要总结
Collect standardized, structured, and comprehensive disease-specific information, produce high-quality and accurate clinical data, provide a sample basis for the analysis and mining of spinal cord injury clinical big data, and establish a spinal cord injury-specific disease data platform to serve clinical work. Promote multi-center cooperation in spinal cord injury research: Establish a unified, standardized, queryable, and sharable efficient spinal cord clinical research data platform to promote multi-center cooperation in spinal cord injury clinical research and enhance the international competitiveness of this research field. Help the region to prepare for the establishment of a spinal cord injury-specific disease data platform for various hospitals in the region, forming a spinal cord injury-specific disease network center to achieve data sharing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •MRI Diagnosis of TCSCI
- •Clinic Diagnosis of TCSCI
- •The injury site must be in cervical spinal cord
- •MRI images of T2WI must be collected within 48 hours after injury
- •Complete and available imaging data, clinical data, including MRI, sex, age
排除标准
- •Spinal cord concussion and MRI scans have no obvious positive performance of spinal cord
- •The quality of MRI images is insufficient or there are serious motion artifacts
结局指标
主要结局
MRI image
时间窗: From 2016 to 2027
original MRI image format DICOM to Nii was based on Python (Version: 3.10.6), and those would be loaded into the MRIcroGMRI imageL software (Version: 12.2). Three spinal surgeons (with 5, 8 and 18 years of experience in interpreting spinal MRI respectively) manually depict the region of interest (ROI) of the lesion area layer by layer, to form three dimensional (3D) volume of interest (VOI). After the primary spinal surgeon finished depicting the injured spinal cord, the senior spinal surgeon checked the quality of ROI and made some adjustments.
ASIA scores
时间窗: From 2016 to 2027
ASIA scores means American Spinal Injury Association Impairment Scale. ASIA has 5 grades depends on the severity of spinal cord injury. Grade A :No sensory or motor function is preserved in sacral segments S4-S5, no sacral sparing. Grade B:Sensory but not motor function is preserved below the neurological level and includes sacral segments S4-S5, AND No motor function is preserved more than three levels below the motor level on either side of the body. Grade C: Motor function is preserved below the neurological level AND More than half of the key muscle functions below the neurological level of injury have a muscle grade of less than 3 (Grades 0-2). Grade D: Motor function is preserved below the neurological level AND At least half (half or more) of the key muscle functions below the neurological level of injury have a muscle grade ≥ 3. Grade E: If sensation and motor function are graded as normal in all segments AND the patient had prior SCI-related deficits.
次要结局
- Age(From 2016 to 2027)
- BMI(From 2016 to 2027)
- Height(From 2016 to 2027)
- Gender(From 2016 to 2027)
- Weight(From 2016 to 2027)
研究者
Jiawei Jiang
Clinical Professor
Affiliated 2 Hospital of Nantong University