Clinical trial NCT06852300: Sport-Related Concussion Recovery in Athletes
Official title: Enhancing Concussion Assessment: A Multimodal Approach Using Neurocognitive Testing, Balance Evaluation, and Functional Near-infrared Spectroscopy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Concussion Mild
Concussion, Brain
Lead sponsor: University of Central Arkansas
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Primary outcomes:
measure: Prefrontal Cortex Activation during Neurocognitive Test using Functional Near- Infrared Spectroscopy (fNIRS) in Division-I Athletes following Sports-Related Concussion
timeFrame: From enrollment to 1 year after becoming asymptomatic.
measure: Prefrontal Cortex Activation During Postural Stability Testing Using Functional Near-Infrared Spectroscopy (fNIRS) in Division-I Athletes Following Sport-Related Concussion
timeFrame: From enrollment to 1 year after becoming asymptomatic
measure: Evaluating the Sensitivity and Specificity of a Multifaceted Concussion Assessment Battery: A Comparison with Functional Near-Infrared Spectroscopy (fNIRS) Outcomes
timeFrame: From enrollment 1 year after becoming asymptomatic
Secondary outcomes:
measure: 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.
timeFrame: From enrollment 1 year after becoming asymptomatic
measure: Exploratory Structural Equation Modeling (ESEM) and Bifactor-ESEM analysis of the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) symptom inventory.
timeFrame: From enrollment 1 year after becoming asymptomatic
measure: Neurocognitive Composite Scores and Symptom Scale Scores from the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT): Traditional vs Remote Administration
timeFrame: From enrollment 1 year after becoming asymptomatic
Other outcomes:
Locations:
city: Conway
country: United States
facility: University of Central Arkansas
state: Arkansas
Study officials:
affiliation: University of Central Arkansas
name: Hyung Rock Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: