跳至主要内容
临床试验/NCT06852300
NCT06852300Enrolling By Invitation不适用

Enhancing Concussion Assessment: a Multimodal Approach Using Neurocognitive Testing, Balance Evaluation, and Functional Near-infrared Spectroscopy

University of Central Arkansas1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2016年4月11日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
1,000
试验地点
1
主要终点
Prefrontal Cortex Activation during Neurocognitive Test using Functional Near- Infrared Spectroscopy (fNIRS) in Division-I Athletes following Sports-Related Concussion

研究概览

简要总结

The goal of this study is to enhance the accuracy and sensitivity of concussion evaluation by integrating traditional assessment tools with emerging neuroimaging technologies, such as Functional Near-Infrared Spectroscopy (fNIRS). By systematically collecting data across multiple assessment domains-including sideline evaluations, neurocognitive testing, balance assessments, vestibular/ocular-motor screening (VOMS), and brain activity measurements-this study aims to improve the diagnostic process and ensure a safer return-to-play protocol for athletes recovering from sport-related concussions.

Research Questions:

  1. How do traditional concussion assessment tools (SCAT, computerized neurocognitive tests, balance tests, and VOMS) compare to fNIRS in detecting changes in brain function following a sport-related concussion?
  2. What is the relationship between pre-injury baseline measures, acute post- injury assessments, and recovery-phase evaluations in athletes diagnosed with a sport-related concussion?
  3. Can fNIRS improve the sensitivity and specificity of concussion diagnosis compared to existing clinical assessments?
  4. How do clinical symptoms, medical history, and other individual factors influence concussion recovery and return-to-play timelines?
  5. Does integrating fNIRS with traditional assessment tools enhance the ability to track recovery progression and inform return-to-play decisions?

This study provides a comprehensive evaluation of concussion diagnosis and recovery while assessing the added value of fNIRS technology in improving clinical decision-making.

详细描述

  1. Study Description This study aims to enhance the accuracy of concussion evaluation and improve return-to-play decisions for athletes recovering from sport-related concussions. By incorporating both traditional assessment tools and advanced neuroimaging technology, such as Functional Near-Infrared Spectroscopy (fNIRS), this research seeks to refine how concussions are diagnosed and monitored.
  2. Who is Participating?

College athletes will be recruited as part of their routine concussion baseline testing. Participants will include:

  • Athletes diagnosed with a sport-related concussion by healthcare providers.
  • Matched control athletes who have not sustained a concussion, assessed on the same schedule as concussed athletes.
  • Contact and non-contact sport athletes who have not experienced head injuries, tested before and after the season.
  1. How is the Study Conducted?

Testing occurs at four key time points:

  • Pre-Season (Baseline): Athletes complete a series of tests to establish their normal cognitive and physical function before any injuries occur.
  • Post-Injury (Within 72 Hours and Asymptomatic): If an athlete sustains a concussion, they undergo assessments shortly after the injury to measure its immediate effects.
  • Return-to-Play: Once the athlete has completed the necessary recovery steps and is cleared to return to play, they are reassessed to evaluate their recovery progress.
  • Re-Baseline (Six Months Post-Injury): Concussed athletes undergo follow- up testing at least six months after the injury to assess long-term recovery and determine whether any persistent neurophysiological changes remain.
  1. What is Being Measured?

This study utilizes a comprehensive concussion evaluation approach that includes:

  • Sideline assessments (e.g., Sports Concussion Assessment Tool [SCAT])
  • Computerized neurocognitive testing (Immediate Post-Concussion Assessment and Cognitive Testing)
  • Objective balance tests (NeuroCom VSR Sport)
  • Vestibular/Ocular-Motor Screening (VOMS)
  • Functional Near-Infrared Spectroscopy (fNIRS) to measure brain activity non-invasively
  • Clinical symptom tracking and medical history review
  1. Why is This Study Important? The data collected will contribute to a robust database aimed at improving concussion assessment methods. By integrating fNIRS with standard concussion tests, this research seeks to enhance diagnostic accuracy, improve the ability to track recovery, and ensure a safer return to play for athletes. Additionally, the inclusion of a re-baseline assessment at six months post-injury will provide valuable insight into the long-term effects of concussion, informing future guidelines for concussion management. Ultimately, these findings could lead to more reliable tools for healthcare providers managing sport-related concussions.

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
18 Years 至 26 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants will be recruited from athletes who have sustained a concussion and/or mild traumatic brain injury (mTBI), as determined by a physical examination conducted by medical staff based on the established concussion definition: biomechnical forces, typically resulting from a direct blow to the head, face, neck, or elsewhere on the body with an impulsive force transmitted to the head.

排除标准

  • Current diagnosis of a psychiatric illness, attention deficit disorder, or learning disability.
  • Current use of psychoactive medications.

结局指标

主要结局

Prefrontal Cortex Activation during Neurocognitive Test using Functional Near- Infrared Spectroscopy (fNIRS) in Division-I Athletes following Sports-Related Concussion

时间窗: From enrollment to 1 year after becoming asymptomatic.

To compare prefrontal hemodynamic activation using fNIRS during the performance of a computerized ImPACT in a sample of concussed Division-I athletes tested within 72 hours post-injury compared to age-matched healthy subjects.

Prefrontal Cortex Activation During Postural Stability Testing Using Functional Near-Infrared Spectroscopy (fNIRS) in Division-I Athletes Following Sport-Related Concussion

时间窗: From enrollment to 1 year after becoming asymptomatic

The purpose of this study is to examine prefrontal cortex activation during postural stability testing in Division-I athletes following a sport-related concussion using functional near-infrared spectroscopy (fNIRS).

Evaluating the Sensitivity and Specificity of a Multifaceted Concussion Assessment Battery: A Comparison with Functional Near-Infrared Spectroscopy (fNIRS) Outcomes

时间窗: From enrollment 1 year after becoming asymptomatic

次要结局

  • Enhancing Concussion Assessment Battery: Evaluating the Validity of Reliable Change Indices (RCI) in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) using Machine Learning Approaches.(From enrollment 1 year after becoming asymptomatic)
  • Exploratory Structural Equation Modeling (ESEM) and Bifactor-ESEM analysis of the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) symptom inventory.(From enrollment 1 year after becoming asymptomatic)
  • Neurocognitive Composite Scores and Symptom Scale Scores from the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT): Traditional vs Remote Administration(From enrollment 1 year after becoming asymptomatic)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyung Rock Lee

Associate Professor

University of Central Arkansas

研究点 (1)

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