Monitoring & Mitigation of Neurologic Injuries to Optimize Resilience After Repetitive Head Impacts (NCT06810193) | Clinical Trial Compass
By InvitationNot Applicable
Monitoring & Mitigation of Neurologic Injuries to Optimize Resilience After Repetitive Head Impacts
United States350 participantsStarted 2025-07-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Optical Coherence Tomography (OCT) of Cerebrospinal Fluid Thickness in the Macula (Part of the Retina)
Timeframe: Pre-season and post-season, 2 weeks
2
Change in Blood Serum Concentrations of Glial Fibrillary Acidic Protein (GFAP)
Timeframe: Baseline 4 to 7 months
3
Change in Blood Serum Concentration of Neurofilament light chain (NfL) in a blood sample
Timeframe: Baseline 4 to 7 months
4
Change in p-231Tau serum concentration in a blood sample
Timeframe: Baseline 4 to 7 months
5
Change in Concussion Index as measured with Quantitative Electroencephalogram (qEEG)