Monitoring & Mitigation of Neurologic Injuries to Optimize Resilience After Repetitive Head Impacts
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aerobic exercise.
- Who it may be relevant to
- Registry conditions: Head Injuries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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.
Interventions
- Other Aerobic exercise
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 outcome measures
- Optical Coherence Tomography (OCT) of Cerebrospinal Fluid Thickness in the Macula (Part of the Retina) [Time frame: Pre-season and post-season, 2 weeks]
- Change in Blood Serum Concentrations of Glial Fibrillary Acidic Protein (GFAP) [Time frame: Baseline 4 to 7 months]
- Change in Blood Serum Concentration of Neurofilament light chain (NfL) in a blood sample [Time frame: Baseline 4 to 7 months]
- Change in p-231Tau serum concentration in a blood sample [Time frame: Baseline 4 to 7 months]
- Change in Concussion Index as measured with Quantitative Electroencephalogram (qEEG) [Time frame: Baseline 4 to 7 months]
- Change in near-point convergence (NPC) [Time frame: Baseline 4 to 7 months]
- Change in Choice reaction time (CRT) [Time frame: Baseline 4 to 7 months]
- Change in blink reflex test [Time frame: Baseline 4 to 7 months]
- Optical Coherence Tomography (OCT) to detect signs of neurodegenertaion in the Retina [Time frame: Pre-season and post-season, 2 weeks]
- Optical Coherence Tomography/Angiography (OCT/A) to assess the vascular structure in the retina [Time frame: Pre-season and post-season, 2 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 3 centers
- University at Buffalo — Amherst
- University of Rochester — Rochester
- The Citadel, The Military College of South Carolina — Charleston
Identifiers
NCT: NCT06810193 · STUDY00010101 · US Department of Defense