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临床试验/NCT03975023
NCT03975023已完成不适用

Assessing Neurophysiological Markers of Brain Function: Investigating Event-Related Potentials and Eye-Tracking Measures in Hockey Players

Frederick Carrick, PhD, FACCN1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2019年7月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
ERP response size

研究概览

简要总结

Traumatic brain injury (TBI) is a health issue impacting athletes and no clinical treatment protocol, other than rest, is yet established. The efficacy of a treatment protocol relies on objective, physiological measures of brain function and ultimately a quantification of injury severity.

The present study aims to assess neurophysiological markers of auditory and visual measures of brain function using the NeuroCatch Platform and eye-tracking technology, respectively. The current gold standard of TBI evaluation, including cognitive and balance assessments, will also be captured.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
14 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Any sex, 14-25 years old inclusively
  • Attending the Creative Artists Agency LLC (CAA) hockey camp in July 2019
  • Able to understand the informed consent/assent form, study procedures and willing to participate in study
  • NeuroCatch Platform-Specific Inclusion Criteria
  • Able to remain seated and focused for 6 minutes
  • Normal hearing capabilities

排除标准

  • Unable to provide informed consent
  • NeuroCatch Platform-Specific Exclusion Criteria
  • Clinically documented hearing issues (e.g. tinnitus, in-ear hearing problems or punctured ear drum)
  • In-ear hearing aid or cochlear implant, hearing device
  • Implanted pacemaker or defibrillator
  • Metal or plastic implants in skull
  • Exposed to an investigational drug or device 30 days prior to start in this study, or concurrent or planned use of investigational drug or device during hockey camp (July 7th - 13th 2019)
  • Not proficient in English
  • Previous exposure to the NeuroCatch™ Platform audio sequences in the last 6 months
  • History of seizures
  • Allergy to rubbing alcohol or EEG gel
  • Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)

结局指标

主要结局

ERP response size

时间窗: 1 week

amplitude in microvolts

Eye-tracking: target accuracy

时间窗: 1 week

distance in millimeters for each eye

Eye-tracking: speed

时间窗: 1 week

degrees per second

ERP response timing

时间窗: 1 week

latency in milliseconds

次要结局

  • Balance(1 week)
  • Cognitive tests(1 year)

研究者

发起方
Frederick Carrick, PhD, FACCN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Frederick Carrick, PhD, FACCN

Prof Frederick R Carrick

Carrick Institute for Graduate Studies

研究点 (1)

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