A 2-Part Capillary Blood Biomarker Cohort Study to Diagnose Adolescent Sport Concussion
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Part B: Determine efficacy of Neurolytixs assay kit for diagnosing adolescent sports concussion
研究概览
简要总结
Concussions are one of the most complex conditions to manage in sport medicine due to the individualized clinical presentation, caused by a complex neurometabolic cascade, and the lack of a diagnostic standard. There is currently no objective measurement for concussion and the reliance on subjective reporting and clinical judgement is imperfect.
In previous clinical studies the investigators determined cutoff values of plasma phosphatidylcholines that provided strong indication that a concussion had occurred. Based on this data, the investigators have developed a custom assay, which will work together with a capillary blood collection device. The current clinical trial will be conducted in two parts. Part A will allow the investigators to determine precise AUC cut-off values for the propriety, novel custom assay, and in Part B the investigators will assess the safety and efficacy of this device for concussion diagnosis in adolescent athletes aged 13-17.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent/assent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female athletes, aged 13-17 inclusive
排除标准
- •Individuals who have suffered a known concussion within the 6 months prior to enrollment
- •Individuals who suffer from an acute neurological disorder
- •Known pregnancy
结局指标
主要结局
Part B: Determine efficacy of Neurolytixs assay kit for diagnosing adolescent sports concussion
时间窗: 12-72 hours post-injury
The change of at least 1 PC below the cutoff threshold (determined in Part A)
Part A: Calculate population reference ranges for 10 phosphatidylcholines (PC) specific to Neurolytixs assay kit.
时间窗: End of Part A (4-6 months)
Population reference values will be determined with the standard definition of a reference range as the interval between which 95% of values of a reference population fall into, in such a way that 2.5% of the time a value will be less than the lower limit of this interval, and 2.5% of the time it will be larger than the upper limit of this interval, whatever the distribution of these values. Measured PC values will be plotted against both sex and the age of participants to which the PCs were measured.
Part A: Generate Area Under the Curve (AUC) values specific to the Neurolytixs assay kit
时间窗: End of Part A (4-6 months)
Generate AUC values for 10 phosphatidylcholines (PCs) for use in Part B
Part B: Determine safety of the Neurolytixs assay kit for adolescent sports concussion
时间窗: Through study completion, up to 1 year
Calculate the number of false negatives (concussions that are not captured by the assay
次要结局
- Part B: Determine whether repeated plasma PC measurements over time correlate with injury symptom resolution or clinical recovery(12 weeks post-injury)