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

N/AEnrolling By InvitationNCT06810193

University of Rochester350 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

350

Conditions

Head Injuries

Interventions

Aerobic exerciseOTHER

After the end-of-season assessments, participants in the Intervention (Exercise or Stretching) arm will be randomized to 2 weeks of daily aerobic exercise for 30 minutes or to 30-minutes of prescribed stretching.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

Optical Coherence Tomography (OCT) of Cerebrospinal Fluid Thickness in the Macula (Part of the Retina)

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).

Time frame: Pre-season and post-season, 2 weeks

Change in Blood Serum Concentrations of Glial Fibrillary Acidic Protein (GFAP)

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.

Time frame: Baseline 4 to 7 months

Change in Blood Serum Concentration of Neurofilament light chain (NfL) in a blood sample

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.

Time frame: Baseline 4 to 7 months

Change in p-231Tau serum concentration in a blood sample

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

Time frame: Baseline 4 to 7 months

Change in Concussion Index as measured with Quantitative Electroencephalogram (qEEG)

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.

Time frame: Baseline 4 to 7 months

Change in near-point convergence (NPC)

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.

Data from ClinicalTrials.gov

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