Clinical trial NCT06810193: Monitoring & Mitigation of Neurologic Injuries to Optimize Resilience After Repetitive Head Impacts
Official title: Monitoring & Mitigation of Neurologic Injuries to Optimize Resilience After Repetitive Head Impacts
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Head Injuries
Keywords: Repetitive Head Impacts
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Optical Coherence Tomography (OCT) of Cerebrospinal Fluid Thickness in the Macula (Part of the Retina)
timeFrame: Pre-season and post-season, 2 weeks
measure: Change in Blood Serum Concentrations of Glial Fibrillary Acidic Protein (GFAP)
timeFrame: Baseline 4 to 7 months
measure: Change in Blood Serum Concentration of Neurofilament light chain (NfL) in a blood sample
timeFrame: Baseline 4 to 7 months
measure: Change in p-231Tau serum concentration in a blood sample
timeFrame: Baseline 4 to 7 months
measure: Change in Concussion Index as measured with Quantitative Electroencephalogram (qEEG)
timeFrame: Baseline 4 to 7 months
measure: Change in near-point convergence (NPC)
timeFrame: Baseline 4 to 7 months
measure: Change in Choice reaction time (CRT)
timeFrame: Baseline 4 to 7 months
measure: Change in blink reflex test
timeFrame: Baseline 4 to 7 months
measure: Optical Coherence Tomography (OCT) to detect signs of neurodegenertaion in the Retina
timeFrame: Pre-season and post-season, 2 weeks
measure: Optical Coherence Tomography/Angiography (OCT/A) to assess the vascular structure in the retina
timeFrame: Pre-season and post-season, 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amherst
country: United States
facility: University at Buffalo
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Charleston
country: United States
facility: The Citadel, The Military College of South Carolina
state: South Carolina
Study officials:
References: