A Case Series of Patients With Spinal Cord Injury Treated With Standard Therapies and NeuroAiD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Spinal cord injury severity based on American Spinal Injury Association Impairment Scale
研究概览
简要总结
SATURN investigates the promising role of NeuroAiD in patients with spinal cord injury and will provide important information on the feasibility of conducting larger controlled trials.
详细描述
SATURN is a prospective cohort study of patients with moderately-severe to severe spinal cord injury, defined as American Spinal Injury Association Impairment Scale A and B, who are treated with open-label NeuroAiD for 6 months in addition to standard care and followed for 24 months. Anonymized data will be prospectively collected at baseline and months 1, 3, 6, 12, 18, and 24 using a secured online system and will include information on demographics, main diagnostics, neurological and functional state, treatment compliance, concomitant therapies, and side effects, if any.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age 18 to 65 years
- •Diagnosed with spinal cord injury between 3 days and 4 weeks
- •American Spinal Injury Association Impairment Scale A or B
- •Informed consent for inclusion into the database is obtained
排除标准
- •Non survivable injury
- •Multiple significant trauma (i.e. significant intracranial and extracranial injuries including limb fractures) that would limit observation of recovery from spinal cord injury
- •Other conditions that would limit clinical assessment of outcomes (e.g. dementia, demyelinating disease, autoimmune disease, etc)
- •Refusal of treatment or contraindication to NeuroAiD
研究组 & 干预措施
Treatment
NeuroAiD
干预措施: NeuroAiD (Drug)
结局指标
主要结局
Spinal cord injury severity based on American Spinal Injury Association Impairment Scale
时间窗: 6 months
Number of patients experiencing adverse events
时间窗: 6 months
Adverse events as individual events and according to organ system, severity, and relatedness
Motor recovery based on American Spinal Injury Association Impairment Scale motor score
时间窗: 6 months
次要结局
- Spinal cord injury severity based on American Spinal Injury Association Impairment Scale(1, 3, 12, 18, 24 months)
- Motor recovery based on American Spinal Injury Association Impairment Scale motor score(1, 3, 12, 18, 24 months)
- Sensory recovery based on American Spinal Injury Association Impairment Scale sensory score(1, 3, 6, 12, 18, 24 months)
- Functional state based on Spinal Cord Independence Measure(1, 3, 6, 12, 18, 24 months)
- Quality of life based on Short Form-8 Health Survey(1, 3, 6, 12, 18, 24 months)