Understanding Repetitive Head Impacts in Soccer Players
This study aims to understand how the time between repetitive head impacts (like soccer heading) affects brain health. Researchers will use a standardized soccer heading protocol, either with sessions separated by 24 hours (Short Interval) or 72 hours (Long Interval). They will also use an investigational BrainScope qEEG device to measure brain activity. The study will measure blood biomarkers (NfL, GFAP, pTau) at different times to see if there are changes. You might be able to join if you are a current soccer player between 18 and 35 years old with at least 5 years of heading experience. The study is looking for 102 participants.
- Study design
- This is an interventional study comparing two different intervals between repetitive head impact sessions. It plans to enroll 102 participants.
- What's involved
- You would participate in soccer heading sessions twice a week for 4 weeks. Blood samples will be taken at the beginning, 24 hours after the last session, and 14 days after the last session.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your blood biomarkers will be measured up to 14 days after your final heading session.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
RHI Interval Effects on Brain Health
At a glance
Conditions
NCT07010887
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Indiana University School of Public Health
Bloomington, Indianastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Keisuke Kawata, PhD · PRINCIPAL_INVESTIGATOR · Indiana University Bloomington Department of Kineseology
Who to contact
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Inclusion
Exclusion
What this trial measures
- Blood Biomarkers - NfLBaseline, 24 hours following the final heading session, 14 days following the final heading session
The primary outcome analyses will be comparing group differences (group x time interactions) in blood biomarkers, specifically NF-L (neurofilament light).
- Blood Biomarkers - GFAPBaseline, 24 hours following the final heading session, 14 days following the final heading session
The primary outcome analyses will be comparing group differences (group x time interactions) in blood biomarkers, specifically GFAP (glial fibrillary acidic protein; nanograms per milliliter).
- Blood Biomarkers - pTauBaseline, 24 hours following the final heading session, 14 days following the final heading session
The primary outcome analyses will be comparing group differences (group x time interactions) in blood biomarkers, specifically phosphorylated tau (picogram per milliliter).
- Optical Coherence Tomography/Angiography (OCT/A) 1Baseline, 24 hours following the final heading session, 14 days following the final heading session
Retinal neural structure will be imaged in one or both eyes using high-definition spectral domain OCT, which will be acquired using a Zeiss Cirrus OCT scanner. The primary OCT variables examined will be macula CSF thickness (an indicator of the gain or loss of neurons or glia in the inner nuclear, ganglion cell and nerve fiber layer). Retinal vascular structure will be acquired using the OCT angiography (OCT/A) capability of the Cirrus.
- Optical Coherence Tomography/Angiography (OCT/A) 2Baseline, 24 hours following the final heading session, 14 days following the final heading session
Retinal neural structure will be imaged in one or both eyes using high-definition spectral domain OCT, which will be acquired using a Zeiss Cirrus OCT scanner. The primary OCT variables examined will be cup-to-disc ratio (an indicator of neurodegeneration at the optic disc).
- Optical Coherence Tomography/Angiography (OCT/A) 3Baseline, 24 hours following the final heading session, 14 days following the final heading session
Retinal vascular structure will be acquired using the OCT angiography (OCT/A) capability of the Cirrus. 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).
- Quantitative Electroencephalography (qEEG)Baseline, 24 hours following the final heading session, 14 days following the final heading session
An Investigational version of the BrainScope FDA-cleared qEEG acquisition device will be used in this study. The investigational nature of the device is simply based on the code which does not produce a diagnostic result for the blinded researcher. Thus, the manufacturer's full device indications/labeling document will be the same as the FDA-cleared version. An eyes-closed resting EEG will be recorded. An FDA cleared multivariate EEG marker of concussion, the Concussion Index (CI) will be used as input for this study modeling. The 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. Other features of interest will be included in the EEG data set. We will use all variables in a single model to analyze which variable, to what extent, contributed to group differences.