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

Not Applicable

Not yet recruiting

• Conditions: Head Injuries

• Registration Number: NCT06810193
• Lead Sponsor: University of Rochester

Brief Summary

The purpose of this Phase 2, double-arm study is to identify repetitive, non-concussive head impacts that impair neurologic functioning, and to test treatments that can mitigate these effects and return functioning to normal as quickly as possible.

Detailed Description

Up to 350 total collegiate athletes and athlete-cadets will be enrolled. Approximately 290 participants participating in varsity contact sports (e.g. soccer, football, etc.) at colleges/universities or military colleges, and up to 60 non-contact athletes/cadets participating in non-contact varsity sports (e.g. swimming, tennis, etc.) will be recruited as controls for the Observational arm; approximately half the participants will be female.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-25
• Study First Submitted QC: 2025-01-30
• Last Update Submitted: 2025-01-30
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Study Start: 2025-08-01
• Primary Completion: 2029-12-01
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Optical Coherence Tomography (OCT) to detect signs of neurodegenertaion in the Retina	Pre-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 (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 sample	Baseline 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 sample	Baseline 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 test	Baseline 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/Angiography (OCT/A) to assess the vascular structure in the retina	Pre-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).

Trial Locations

Locations (3)

University at Buffalo; 🇺🇸 Amherst, New York, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

The Citadel, The Military College of South Carolina; 🇺🇸 Charleston, South Carolina, United States