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Enrolling by Invitation

NCT Number: NCT06810193

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

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.

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Key information

Conditions

Head Injuries Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University at Buffalo, Amherst, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic Exercise

Other

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.

Primary outcomes

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

    Time frame: 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).

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  6. Change in near-point convergence (NPC)

    Time frame: 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.

  7. Change in Choice reaction time (CRT)

    Time frame: 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.

  8. Change in blink reflex test

    Time frame: 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.

  9. Optical Coherence Tomography (OCT) to detect signs of neurodegenertaion in the Retina

    Time frame: 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.

  10. Optical Coherence Tomography/Angiography (OCT/A) to assess the vascular structure in the retina

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Acronym: MONITOR-RHI

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Feb 5, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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