Sport-Related Concussion Recovery in Athletes

NCT06852300 | Enrolling By Invitation

• 1 other identifier: ERI19-141
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.Can fNIRS improve the sensitivity and specificity of concussion diagnosis compared to existing clinical assessments?
4. 4.How do clinical symptoms, medical history, and other individual factors influence concussion recovery and return-to-play timelines?
5. 5.Does integrating fNIRS with traditional assessment tools enhance the ability to track recovery progression and inform return-to-play decisions?

Conditions

Concussion Mild; Concussion, Brain

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• 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

Study Arms (2)

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).

Device: Concussion Assessment Battery

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.

Device: Concussion Assessment Battery

Interventions

Concussion Assessment Battery 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.

Concussed and Matched control Pool; Pre-season and Post-Season Subject Pool

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Central Arkansas: lead

Study Sites (1)

University of Central Arkansas

Conway, Arkansas, 72034, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Hyung Rock Lee, Ph.D

  University of Central Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 28, 2025
• Study Start: April 11, 2016
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: March 6, 2025

Record last verified: 2024-11

Locations

US (1)