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NCT06810193

Monitoring & Mitigation of Neurologic Injuries to Optimize Resilience After Repetitive Head Impacts

Enrolling by Invitation
NAAges 18+InterventionalSupportive care
University of Rochester
~350 participants
Updated 2025-09-11 on ClinicalTrials.gov
What's tested:Aerobic exercise

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Optical Coherence Tomography (OCT) of Cerebrospinal Fluid Thickness in the Macula (Part of the Retina)
Measured over Pre-season and post-season, 2 weeks
+9 more outcomes measured

Conditions

Head Injuries

Explore related trials

Head InjuryRepetitive Head Impacts

Where it's being run

3 sites across 2 states
New York2
South Carolina1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 18 years
Collegiate athlete or athlete-cadet anticipated to be an active member of a varsity sport team.

Exclusion

Any head, neck, or face injury in the 3 months prior to enrollment that precludes participation in contact sports or wearing a mouth guard sensor
History of neurological or psychiatric disorders or neurological disorders that impact electrical activity in the brain (such as seizure disorders), or diagnosed learning disability, that in the opinion of the investigator, would interfere with participation in the study.
Participants currently undergoing active treatment for migraine, depression and/or anxiety or ADHD will not be excluded as these are high prevalence conditions in the adolescent and collegiate population (8-30%). However, exploratory stratified analyses will be conducted where possible.
Participants with eye conditions or diseases that could impact the blood vessels in the eye.
Determination that the participant is unsuitable for study entry or potentially unable to complete all aspects of the study based on the judgement of the Site Investigator or Study PI.

What this trial measures

  • Optical Coherence Tomography (OCT) of Cerebrospinal Fluid Thickness in the Macula (Part of the Retina)Pre-season and post-season, 2 weeks

    A primary OCT variables examined will be macula cerebrospinal fluid (CSF) thickness (an indicator of the gain or loss of neurons or glia in the inner nuclear, ganglion cell and nerve fiber layer).

  • Change in Blood Serum Concentrations of Glial Fibrillary Acidic Protein (GFAP)Baseline 4 to 7 months

    Glial Fibrillary Acidic Protein (GFAP) concentration will determine if there is a 11.9 pg/mL or greater change in GFAP in each participant over the course of the study.

  • Change in Blood Serum Concentration of Neurofilament light chain (NfL) in a blood sampleBaseline 4 to 7 months

    The neurologic test battery consists of blood draws for serum brain proteins: Neurofilament light chain (NfL) concentrations will be observed for changes over the course of the study.

  • Change in p-231Tau serum concentration in a blood sampleBaseline 4 to 7 months

    The neurologic test battery consists of blood draws for serum brain proteins: p231Tau will be observed for changes over the course of the study.

  • Change in Concussion Index as measured with Quantitative Electroencephalogram (qEEG)Baseline 4 to 7 months

    The Quantitative Electroencephalogram (qEEG) Concussion Index (CI) includes measures of power (absolute and relative), mean frequency, connectivity (asymmetry, coherence, phase lag, phase synchrony), complexity (fractal dimension and scale-free activity), and information theory (entropy), across and within frequency bands.

  • Change in near-point convergence (NPC)Baseline 4 to 7 months

    Near point of convergence (NPC) is a measurement of how close an object can be brought to the eyes while the eyes are focused on it.

  • Change in Choice reaction time (CRT)Baseline 4 to 7 months

    Choice reaction time (CRT) refers to the time it takes for a person to react to a stimulus by selecting a specific response from multiple options.

  • Change in blink reflex testBaseline 4 to 7 months

    A blink reflex test, also known as a corneal reflex test, is a non-invasive procedure that measures the electrical activity of the facial nerves when stimulated.

  • Optical Coherence Tomography (OCT) to detect signs of neurodegenertaion in the RetinaPre-season and post-season, 2 weeks

    OCT will be used to measure the cup-to-disc ratio of the optic disc, and indicator of neurodegeneration.

  • Optical Coherence Tomography/Angiography (OCT/A) to assess the vascular structure in the retinaPre-season and post-season, 2 weeks

    Retinal vascular structure will be acquired using the OCT angiography (OCT/A). The primary OCT/A variable examined will be foveal avascular zone (FAZ) area reflecting the size of the central portion of the macula which contains no blood vessels, and which increases in size with loss of capillaries in the surrounding region).