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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:
This study provides a comprehensive evaluation of concussion diagnosis and recovery while assessing the added value of fNIRS technology in improving clinical decision-making.
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.
Who is Participating?
College athletes will be recruited as part of their routine concussion baseline testing. Participants will include:
How is the Study Conducted?
Testing occurs at four key time points:
What is Being Measured?
This study utilizes a comprehensive concussion evaluation approach that includes:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concussed and Matched control Pool | The concussed group consists of collegiate athletes who have been diagnosed with a sport-related concussion by healthcare providers and meet the specified inclusion criteria. Injured participants will undergo testing within 72 hours of the injury and at predetermined time points post-concussion. Matched control participants will be assessed at the same time intervals as their injured counterparts to ensure comparability. The concussion test battery will comprise five assessments designed to evaluate sport-related concussion: 1. Health Questionnaire, 2. Sport Concussion Assessment Tool (SCAT), 3. Vestibular Ocular Motor Screening (VOMS) 4. Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), 5. Balance Assessment. Additionally, the NIRSIT scanner will be utilized at each testing session to assess cognitive function and brain activity through Functional Near-Infrared Spectroscopy (fNIRS). |
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| Pre-season and Post-Season Subject Pool | Participants will complete baseline concussion testing upon initiation into their intercollegiate athletic program. This group will consist of uninjured collegiate athletes from both contact and non-contact sports. Testing will be conducted at two time points: pre-season and post-season. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concussion Assessment Battery | Device | The conclusion test battery will comprise five assessment designed to evaluate sport-related concussion:
Functional Neuroimaging Functional Near-Infrared Spectroscopy (fNIRS) is a non-invasive neuroimaging technology that measures brain activity by detecting changes in blood oxygenation. The NIRSIT scanner will be employed at each testing session to assess cognitive function using the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and postural stability using the NeuroCom VSR Sport system. |
| Measure | Description | Time Frame |
|---|---|---|
| Prefrontal Cortex Activation during Neurocognitive Test using Functional Near- Infrared Spectroscopy (fNIRS) in Division-I Athletes following Sports-Related Concussion | 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. | From enrollment to 1 year after becoming asymptomatic. |
| Prefrontal Cortex Activation During Postural Stability Testing Using Functional Near-Infrared Spectroscopy (fNIRS) in Division-I Athletes Following Sport-Related Concussion | 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). | From enrollment to 1 year after becoming asymptomatic |
| Evaluating the Sensitivity and Specificity of a Multifaceted Concussion Assessment Battery: A Comparison with Functional Near-Infrared Spectroscopy (fNIRS) Outcomes | From enrollment 1 year after becoming asymptomatic |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Computerized neurocognitive tests like Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) are becoming more widely used by sports medicine professionals to evaluate concussions. A baseline ImPACT test is often recommended to help compare post-injury results, providing a more accurate picture of an athlete's cognitive function after a concussion. One method ImPACT uses to assess changes in cognitive function is the Reliable Change Index (RCI), which helps determine whether a difference in scores is meaningful. However, RCI has limitations, such as being less sensitive to real cognitive changes and the potential for misinterpretation. This study explores how machine learning approaches could improve the accuracy of concussion assessments using ImPACT scores. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be recruited through university-affiliated sports medicine providers. When a student-athlete, including intramural sports participants, exhibits any signs, symptoms, or behaviors consistent with a sport-related concussion, they will be removed from practice or competition by either a member of the coaching staff or the sports medicine staff.
Upon confirmation of a concussion diagnosis by the medical staff, the concussed athlete will be selected as a study participant and will be required to follow the post-concussion protocol outlined by the participating institution, which adheres to NCAA standards.
Whenever possible, control subjects will be recruited from the same team, other sports teams, and/or students at the participating university who meet the inclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Hyung Rock Lee, Ph.D | University of Central Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Central Arkansas | Conway | Arkansas | 72034 | United States |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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. | The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) includes a symptom inventory widely used to assess self-reported concussion symptoms in athletes. This study will only use the self-reported symptom scale from the ImPACT as the primary Outcome Measure, with no other sub-scores or assessments included. The ImPACT symptom scale includes 22 symptoms rated on a 0 to 6 severity scale, with 0 indicating no symptom and 6 indicating the most severe. The total symptom score, ranging from 0 to 132, will serve as the primary Outcome Measure. Higher scores indicate greater symptom severity. This study will apply Exploratory Structural Equation Modeling (ESEM) and bifactor-ESEM to examine the factor structure, evaluate general and specific symptom dimensions, and improve the interpretability of ImPACT symptom scores for more accurate clinical assessments. | 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 | ImPACT is a widely utilized tool for assessing the cognitive function of collegiate athletes. Previous research has demonstrated that cognitive performance may vary depending on the environment in which concussion assessments are conducted. The ImPACT test battery consists of the following components administered in sequential order: (1) Demographics, (2) Symptom Scale, (3) Word Memory, (4) Design Memory, (5) X's and O's, (6) Symbol Match, (7) Color Match, (8) Three Letters, (9) Word Memory Delayed Recall, and (10) Design Memory Delayed Recall. All tests are automatically scored by the software. During the COVID-19 pandemic, many student-athletes transitioned from traditional, in-person concussion assessments to remote, at-home testing. This study aims to determine whether remote testing yields results comparable to traditional testing, ensuring the accuracy and consistency of concussion assessments regardless of the testing environment. | From enrollment 1 year after becoming asymptomatic |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |