Phenotypes, Biomarkers and Pathophysiology in Syringomyelia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change of the spinal cord function
研究概览
简要总结
The aim of this study is to determine the clinical spectrum and natural progression of Syringomyelia (SM) and related disorders in a prospective single center study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the etiology and molecular mechanisms of these diseases.
详细描述
Syringomyelia is a chronic central spinal cord injury, which is characterized by dilation of the central canal of the spinal cord. At present, the treatment of syringomyelia is mainly through surgical decompression to restore the disturbance of cerebrospinal fluid circulation. Due to the heterogeneity of the etiology of syringomyelia, almost all published studies on the clinical outcome and prognostic factors of syringomyelia are relatively limited, and most of them are retrospective. It is not clear which is the most reliable predictor of clinical outcome. Therefore, the researchers conducted this prospective cohort study to identify the occurrence, development and outcome of syringomyelia and determine the main prognostic factors through clinical scales, biomarkers and electrophysiology.
At study visits a standardized clinical examination will be performed including application of clinical rating scales. At all study visits, patients will be asked to donate biosamples; biomaterial collection is optional and participants can elect to participate in sampling of blood, urine, CSF, and/or a muscle biopsy.
Optionally, additional examinations may be performed including imaging, neurophysiological examination, analysis of patient or observer reported outcomes and analysis to characterize molecular biomarkers.
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
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients who was diagnosed as syringomyelia including: Chiari malformation， Basilar Impression， subarachnoid obstruction， patient not received surgical or interventional treatment before， patient willing and able to participate in the registry，
- •Hydrocephalus or other neurodegenerative disease and normal subjects.
排除标准
- •patient received surgical treatment or interventional treatment before
- •patient is pregnant
- •patient unable to complete follow-up
- •patient with other spinal lesions
- •other nervous system diseases
结局指标
主要结局
Change of the spinal cord function
时间窗: 1 day before operation and 3 days, 3 months, 12 months postoperation
American Spinal Injury Association(ASIA) Score for evaluating the spinal cord function
次要结局
- modified Japanese Orthopaedic Association Scores (mJOA)(1 day before operation and 3 days, 3 months, 12 months postoperation)
- Incidence of perioperative complications(1 week)
- Chicago Chiari outcome scale (CCOS)(3 days, 3 months, 12 months postoperation)
- Electrophysiology results(1 day before operation and 3 days, 3 months postoperation)
- the rates of syrinx reduction(3 days, 3 months postoperation)
- Klekamp and Sammi syringomyelia scale(1 day before operation and 3 days, 3 months, 12 months postoperation)
- molecular profiling results(1 day before operation and 3 days, 3 months postoperation)
- Visual Analog Scale (VAS)(1 day before operation and 3 days, 3 months, 12 months postoperation)
研究者
Fengzeng Jian
director of neurospine department, Xuanwu hospital
Xuanwu Hospital, Beijing