Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-31 @ 6:18 PM
Study NCT ID:
NCT06852300
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-06
First Post:
2025-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sport-Related Concussion Recovery in Athletes
Sponsor:
University of Central Arkansas
Organization:
Study Overview
Official Title:
Enhancing Concussion Assessment: A Multimodal Approach Using Neurocognitive Testing, Balance Evaluation, and Functional Near-infrared Spectroscopy
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
3. 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.
4. 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
5. 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.
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.
3. 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.
4. 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
5. 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: