By InvitationNot Applicable

Sport-Related Concussion Recovery in Athletes

United States1,000 participantsStarted 2016-04-11

Plain-language 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.

Who can participate

Age range

18 Years – 26 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

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

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

Trial details

NCT IDNCT06852300

SponsorUniversity of Central Arkansas

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-05-01

View on ClinicalTrials.gov More Concussion Mild trials