Sport-Related Concussion Recovery in Athletes

NCT ID: NCT06852300

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-11
• Study Completion Date: 2030-05-31

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.

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.

Conditions

Concussion Mild; Concussion, Brain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Concussion Assessment Battery

Intervention Type: DEVICE

The conclusion test battery will comprise five assessment designed to evaluate sport-related concussion:

1. Health Questionnaire - Including as assessment of signs and symptoms.

2. Sport Concussion Assessment Tool (SCAT)

3. Vestibular Ocular Motor Screening (VOMS)

4. Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT)

5. Postural stability assessment (NeuroCom VSR Sport).

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.

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.

Concussion Assessment Battery

Intervention Type: DEVICE

The conclusion test battery will comprise five assessment designed to evaluate sport-related concussion:

1. Health Questionnaire - Including as assessment of signs and symptoms.

2. Sport Concussion Assessment Tool (SCAT)

3. Vestibular Ocular Motor Screening (VOMS)

4. Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT)

5. Postural stability assessment (NeuroCom VSR Sport).

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.

Interventions

Concussion Assessment Battery

The conclusion test battery will comprise five assessment designed to evaluate sport-related concussion:

1. Health Questionnaire - Including as assessment of signs and symptoms.

2. Sport Concussion Assessment Tool (SCAT)

3. Vestibular Ocular Motor Screening (VOMS)

4. Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT)

5. Postural stability assessment (NeuroCom VSR Sport).

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Central Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Hyung Rock Lee

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hyung Rock Lee, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Central Arkansas

Locations

University of Central Arkansas

Conway, Arkansas, United States

Countries

United States

Other Identifiers

ERI19-141

Identifier Type: -

Identifier Source: org_study_id