Role of Autoantibodies in Spontaneous Functional Recovery After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Changes in ASIA scores
研究概览
简要总结
The purpose of this study is to determine the autoantibody profiles after spinal cord injury and their role in spontaneous functional recovery.
详细描述
Most patients experience variable degrees of functional recovery after spinal cord injury (SCI), predominantly in the first months after lesion. In SCI animal models, autoantibodies are pathogenic and their titers rise up at the time when spontaneous recovery stops. The aim of this study is to determine the autoantibody profiles after SCI and to infer their relation with functional recovery. To achieve this, autoantibody profiles, biochemical, hematological and immune-related parameters (cytokines, chemokines and growth factors) will be determined from a serum blood sample and functional recovery will be evaluated accordingly to standardized scales.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Traumatic or non-progressive vascular SCI
- •Less than 45 days after lesion
- •Any neurological level
- •Complete and incomplete lesions
- •If patient has been treated with glucocorticoids, it should have passed at least 7 days from the end of the treatment
排除标准
- •Cauda equina syndrome
- •Autoimmune disorder
- •Tumor (even if benign)
- •Neurodegenerative disease
结局指标
主要结局
Changes in ASIA scores
时间窗: 4 months
次要结局
- Change in neurological level of injury(4 months)
- Change in ASIA impairment scale (AIS)(4 months)
研究者
Dr. Angel Arevalo Martin
Ph.D.
Hospital Nacional de Parapléjicos de Toledo