Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in the College Age Athletes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Changes in BNA™ measures during the sport season in both concussed and non concussed athletes compared to pre season BNA™ baseline measures.
研究概览
简要总结
Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a noninvasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA™) to temporally and spatially map brain function, connectivity and synchronization.
The proposed study will provide additional evidence for the utility and contribution of the BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion) in concussion management.
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
- 17 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 17-24, both genders, enrolled in a recognized college and members of a sport team of their school.
排除标准
- •Current or history of any of the following:
- •TBI (i.e., Glasgow Coma Scale <13) or brain surgery
- •Any psychiatric disorder
- •Any Neurological disorder
- •Substance abuse
- •Special education
- •Any medication affecting CNS
- •Significant sensory deficits such as deafness or blindness
- •Residual symptoms or deficits related to a previous concussion
结局指标
主要结局
Changes in BNA™ measures during the sport season in both concussed and non concussed athletes compared to pre season BNA™ baseline measures.
时间窗: an average of 1 year
Correlation of the BNA measures in both concussed and non concussed athletes to the clinical diagnosis.
时间窗: an average of 1 year
To assess the clinical utility of changes in BNA in assisting with clinical decision-making.
时间窗: an average of 1 year
次要结局
未报告次要终点