NCT01673464已完成不适用
A Prospective Study of Brain Network Activation (BNA) Changes in High School Athletes Following Concussion
ElMindA Ltd1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2012年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Changes in Brain Network Activation(BNA™)Scores From Baseline Over Post Concussion Recovery Period
研究概览
简要总结
The main purpose of this study is to prospectively examine changes in Brain Network Activation(BNA)following concussion in high school athletes. In addition, the study will examine the relationship between changes in BNA to symptoms, cognitive performance and vestibular function from baseline to 1-7, 8-14 and 15-21 day post injury intervals in high school athletes with concussion.
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
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 13-18 years
- •Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments
- •Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self)
排除标准
- •Current or history of TBI (i.e., Glasgow Coma Scale <13) or brain surgery
- •Current or history of any psychiatric disorder (except ADD/ADHD), e.g., depression, bipolar disorder, schizophrenic disorder
- •Substance abuse within the last year
- •Current or history of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder
- •Current or history of any Neurological disorder, e.g., epilepsy, seizures
- •History of any medication affecting CNS within the last year, e.g., antidepressants, anticonvulsants, Ritalin, first generation antihistamines, etc.
- •Current or history of Significant sensory deficits such as deafness or blindness
- •Current or history of Clinically significant abnormal laboratory values or ECG
- •A concussion within the last year
- •Current or history of residual symptoms or deficits related to a previous concussion
- •Diagnosis of autistic spectrum disorders, e.g., Asperger's syndrome, High functioning Autism, PDD
- •Currently with lice or open wounds on scalp
- •Long and thick hair that prevents the proper administration of an EEG cap
结局指标
主要结局
Changes in Brain Network Activation(BNA™)Scores From Baseline Over Post Concussion Recovery Period
时间窗: baseline, 1-7, 8-14, and 15-21 day post-injury intervals
To examine prospectively changes in brain network activation (BNA) from baseline to 1-7, 8-14, and 15-21 day post-injury intervals, and/or to recovery (i.e., return to activity) in high school athletes with concussion.
次要结局
- Relationship between changes in BNA to changes in cognitive performance from baseline over post concussion recovery period(baseline, 1-7, 8-14, and 15-21 day post-injury intervals)
- Relationship between changes in BNA to changes in vestibular function from baseline over post concussion recovery period(baseline, 1-7, 8-14, and 15-21 day post-injury intervals)
- Relationship between changes in BNA to changes in symptoms from baseline over post concussion recovery period(baseline, 1-7, 8-14, and 15-21 day post-injury intervals)
研究者
研究点 (1)
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