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Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Sport Concussion Assessment - Test Stability and Effect of Concussion

2019年9月23日 更新者:ElMindA Ltd

Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport. Despite ongoing research, there is no highly sensitive clinical test for cognitive function. This makes the clinical diagnosis of concussion particularly difficult as the clinical presentation of concussion is highly variable with symptoms often evolving over time. Given the variability in concussion presentations, there is no single test that can diagnose a concussion. Current recommendations are that sports medicine providers apply a multifaceted concussion assessment battery that combines subjective symptoms, motor control and cognitive assessment.

This investigation is designed to evaluate the clinical utility of ElMindA's BNA scores in detecting and managing concussive injuries. This study will establish the reliability of BNA™ scores over clinically relevant assessment intervals and investigate the effect of SRC and sub-concussive head impacts on BNA scores.

研究概览

地位

完全的

研究类型

观察性的

注册 (实际的)

109

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Michigan
      • Ann Arbor、Michigan、美国、48105
        • Michigan NeuroSport Concussion Program

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

14年 至 26年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Phase 1: gender-balanced groups of 30 healthy high school (14-17 years old) and 30 healthy college aged (18-26 years old) individuals who participate in non-contact sports Phase 2a: 30 high school and/or collegiate athletes aged 14-26 years with concussion and 30 matched control athletes.

Phase 2b: at least 30 high school and/or collegiate contact sport athletes aged 14-26 years whose head impacts are monitored during games and practices.

描述

Phase 1:

Inclusion Criteria:

  • Aged 14-26 years
  • Enrolled in a recognized high school or college
  • Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self)
  • Currently participate in a non-contact sport.
  • Member of an organized athletic team or regularly train for and participate in independent athletic contests during at least one sports season.
  • Right handed subject

Exclusion Criteria:

  • Currently participate in a contact sport.
  • Bald or has dread locks/long and thick hair.
  • Any diagnosed psychiatric disorder
  • History of CNS injury or disease
  • Any neuropsychological disorders
  • History of learning disability.
  • History of any medication affecting CNS.
  • Active head lice infection, open scalp wound, deafness or/and blindness.
  • Sustained a diagnosed concussion within the previous 6 months

Phase 2a:

Inclusion Criteria:

  • Aged 14-26 years.
  • For Arm 1: Within 1 week post-concussion (sports-related).
  • For Arm 1: Currently symptomatic
  • Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self).
  • Member of an organized athletic team or regularly train.
  • Enrolled in a high school or college.

Exclusion Criteria:

  • Bald or has dread locks/long and thick hair.
  • Current or history of ADHD.
  • Active head lice infection, open scalp wound, deafness or/and blindness.
  • Sustained a concussion within the past 6 months.
  • Current or history of moderate or severe TBI, any brain injury with positive neuroimaging findings, or brain surgery.

Phase 2b:

Inclusion Criteria:

  • Aged 14-26 years.
  • Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self).
  • Member of a contact sport team which carries out head impact monitoring over the course of the playing season.
  • Enrolled in a high school or college.

Exclusion Criteria:

  • Bald or has dread locks/long and thick hair.
  • Current or history of ADHD.
  • Active head lice infection, open scalp wound, deafness or/and blindness.
  • Sustained a concussion within the past 6 months.
  • Current or history of moderate or severe TBI, any brain injury with positive neuroimaging findings, or brain surgery.
  • Any diagnosed psychiatric disorder.
  • History of CNS injury or disease
  • Any neuropsychological disorders.
  • History of learning disability.
  • History of any medication affecting CNS.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
Phase I - Normative
Athletes who does not participate in contact sport with no recent concussion
Phase IIa - Concussed
Athletes with recent concussion
Phase IIa - Control
Athletes with no recent concussion
Phase IIb - Athletes
Athletes with no recent concussion

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Change of Brain Network Activation(BNA™)Scores
大体时间:P.I - days 0 , 7, 42, 365 ; P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
P.I - days 0 , 7, 42, 365 ; P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season

次要结果测量

结果测量
大体时间
Correlation Of The Change In BNA™ Scores To Clinical Diagnstic
大体时间:P.I - days 0 , 7, 42, 365 ; P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
P.I - days 0 , 7, 42, 365 ; P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
Correlation Of The Change In BNA™ Scores To Neurocognitive Tests Scroes
大体时间:P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
Correlation Of The Change In BNA™ Scores To Reaction Time Scores
大体时间:P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年2月1日

初级完成 (实际的)

2015年12月1日

研究完成 (实际的)

2015年12月1日

研究注册日期

首次提交

2012年2月12日

首先提交符合 QC 标准的

2012年2月14日

首次发布 (估计)

2012年2月17日

研究记录更新

最后更新发布 (实际的)

2019年9月25日

上次提交的符合 QC 标准的更新

2019年9月23日

最后验证

2019年9月1日

更多信息

与本研究相关的术语

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研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

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