An observational study in Concussion Mild and Concussion, Brain, sponsored by University of Central Arkansas. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-06.
Sponsored by University of Central Arkansas · Observational
Among 418 studies in Brain Concussion with a site in United States — 100 open to participants now, 121 under way, 5 of them phase 3. Brain Concussion · United States.
Among the 418 studies in Brain Concussion with a site in United States, this one is the 9th largest by planned enrollment of the 96 observational ones, is one of 35 that started in 2016, is one of 96 observational ones, reaches primary completion later than 115 of the 120 other live ones, and was the 370th registered.
637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 149 across 166 observational studies indexed under Brain Concussion.
Browse Brain Concussion studies →100 of the 418 studies in Brain Concussion with a site in United States are open now, in 2 countries. Each count lists the studies.
Of the 112 Brain Concussion studies recruiting now, 33 (29%) set no upper age limit and 72 (64%) stop at 75 or younger; 24 take children under 18; 38 take healthy volunteers.
This study: 18 Years to 26 Years · all sexes · healthy volunteers too.
The full table on the hub →418 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 35 started in 2016.
Median enrollment 60 across the 321 interventional studies, 147 across the 96 observational. Of the 259 that completed or were terminated, 68 (26%) have results posted.
59 of 418 have an industry lead sponsor. The 10 most frequent:
University of Central Arkansas is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
University of Central Arkansas has 1 study filed under Brain Concussion — fewer than ten, so there is no comparison to draw.
49 of the studies in Brain Concussion with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04867317Phase 3VA Office of Research and DevelopmentGrowth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD) | 2027-02-28 |
| NCT05320822University of North Carolina, Chapel HillA Pragmatic Rehabilitation Intervention: The Active Rehab Study | 2026-11-28 |
| NCT06109909VA Office of Research and DevelopmentPilot Study of Neurofeedback for Photosensitivity in Mild Traumatic Brain Injury | 2026-11-30 |
| NCT02670161Endeavor HealthQuality Improvement and Practice Based Research in Neurology Using the EMR | 2026-12 |
| NCT04708613David Okonkwo, MD, PhDUniversity of Pittsburgh Brain Health Initiative | 2026-12 |
Among the 418 studies in Brain Concussion with a site in United States, from their registry updates:
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:
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 is Participating?
College athletes will be recruited as part of their routine concussion baseline testing. Participants will include:
How is the Study Conducted?
Testing occurs at four key time points:
What is Being Measured?
This study utilizes a comprehensive concussion evaluation approach that includes:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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.
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.
Time frame: 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).
Time frame: 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
Time frame: From enrollment 1 year after becoming asymptomatic
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.
Computerized neurocognitive tests like Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) are becoming more widely used by sports medicine professionals to evaluate concussions. A baseline ImPACT test is often recommended to help compare post-injury results, providing a more accurate picture of an athlete's cognitive function after a concussion. One method ImPACT uses to assess changes in cognitive function is the Reliable Change Index (RCI), which helps determine whether a difference in scores is meaningful. However, RCI has limitations, such as being less sensitive to real cognitive changes and the potential for misinterpretation. This study explores how machine learning approaches could improve the accuracy of concussion assessments using ImPACT scores.
Time frame: 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.
The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) includes a symptom inventory widely used to assess self-reported concussion symptoms in athletes. This study will only use the self-reported symptom scale from the ImPACT as the primary Outcome Measure, with no other sub-scores or assessments included. The ImPACT symptom scale includes 22 symptoms rated on a 0 to 6 severity scale, with 0 indicating no symptom and 6 indicating the most severe. The total symptom score, ranging from 0 to 132, will serve as the primary Outcome Measure. Higher scores indicate greater symptom severity. This study will apply Exploratory Structural Equation Modeling (ESEM) and bifactor-ESEM to examine the factor structure, evaluate general and specific symptom dimensions, and improve the interpretability of ImPACT symptom scores for more accurate clinical assessments.
Time frame: 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
ImPACT is a widely utilized tool for assessing the cognitive function of collegiate athletes. Previous research has demonstrated that cognitive performance may vary depending on the environment in which concussion assessments are conducted. The ImPACT test battery consists of the following components administered in sequential order: (1) Demographics, (2) Symptom Scale, (3) Word Memory, (4) Design Memory, (5) X's and O's, (6) Symbol Match, (7) Color Match, (8) Three Letters, (9) Word Memory Delayed Recall, and (10) Design Memory Delayed Recall. All tests are automatically scored by the software. During the COVID-19 pandemic, many student-athletes transitioned from traditional, in-person concussion assessments to remote, at-home testing. This study aims to determine whether remote testing yields results comparable to traditional testing, ensuring the accuracy and consistency of concussion assessments regardless of the testing environment.
Time frame: From enrollment 1 year after becoming asymptomatic
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2016 (actual). Primary completion is estimated for May 2030, 168 months after the start.
Of 72 non-industry observational studies under Brain Concussion, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 188. This study's planned 168 months is above that.
Counting every sponsor, half of 94 studies reached it within 35 months; a quarter within 16 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
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University of Central Arkansas