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Investigator Initiated Protocol for the: Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion and the Establishment of Normative Data in Youth and Adolescents Athletes

2020年7月20日 更新者:ElMindA Ltd

Investigator Initiated Protocol for the: Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion and the Establishment of Normative Data in Youth and Adolescents Athletes.

This study's objectives are:

  • To prospectively examine changes in brain network activation (BNA™) from baseline to recovery (i.e., return to activity) in youth and adolescent athletes with concussion.
  • To assess the clinical utility of changes in BNA to assist in clinical decision-making.
  • To generate normative BNA data.

研究概览

地位

完全的

详细说明

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.

研究类型

观察性的

注册 (实际的)

200

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

    • Ohio
      • Cincinnati、Ohio、美国、45229-3039
        • Cincinnati children's hospital Sport center

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

8年 至 18年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

male and female athletes

描述

Inclusion Criteria:

  • • Male and Female Athletes: Age 8-14 (Arm 1) or 8-18 years (Arm 2).

    • For Arm 1 - Over 3 days and below 7 days post-concussion (sports-related) and currently symptomatic
    • 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 Parental consent

Exclusion Criteria:

  • Currently with lice or open wounds on scalp.
  • Long and thick hair that prevents the proper administration of an EEG cap.
  • Significant sensory deficits, e.g., deafness or blindness.

    • Normative Exclusion Criteria:
  • Any chronic disease as determined by clinical evaluation and medical history.
  • Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc. as determined by clinical evaluation and the Mini International Neuropsychiatric Interview (MINI)
  • Any CNS neurologic disorder, e.g., epilepsy, seizures, etc. as determined by clinical evaluation
  • Any neuropsychological disorders, e.g.: ADHD, Autistic Spectrum Disorder (ASD), etc. as determined by clinical evaluation
  • History of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder.
  • History of any medication affecting CNS within the last 3 months, e.g., antidepressants, anticonvulsants, psychostimulants, first generation antihistamines, etc.
  • Substance abuse in the last 3 months.
  • History of any clinically significant brain trauma as determined by the investigator.

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

队列和干预

团体/队列
Normative study
male and female athletes, ages 8-14.
Baseline
male and female athletes, ages 8-18.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
quantitative and qualitative analysis of brain network activation (BNA) in participants that have sustained concussion compared to their baseline test.
大体时间:1 year
quantitative and qualitative analysis of brain network activation (BNA) in participants that have sustained concussion compared to their baseline test.
1 year

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

调查人员

  • 首席研究员:Gregory Myer, PhD、Children's Hospital Medical Center, Cincinnati

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

2014年4月1日

初级完成 (实际的)

2018年6月1日

研究完成 (实际的)

2018年6月1日

研究注册日期

首次提交

2014年4月3日

首先提交符合 QC 标准的

2014年4月4日

首次发布 (估计)

2014年4月7日

研究记录更新

最后更新发布 (实际的)

2020年7月22日

上次提交的符合 QC 标准的更新

2020年7月20日

最后验证

2020年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • ELM-23

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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