RecruitingNot Applicable

RHI Interval Effects on Brain Health

United States102 participantsStarted 2025-08-05

Plain-language summary

Military service members frequently experience repetitive insults or impacts to the head (RHIs). The purpose of the proposed randomized controlled trial is to understand how time intervals affect neurological responses to repetitive subconcussive head impacts.

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

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: * Current soccer player (intercollegiate, club, intramural, recreational). * At least 5 years of soccer heading experience (justification below). * Ability to provide informed consent without a legally authorized representative (LAR). Exclusion Criteria: * Any head, neck, or face injury within the 6 months prior to enrollment, including concussions, that precludes participation in contact sports. * Participants with eye conditions or diseases that could impact the blood vessels in the eye -such as but not limited to: glaucoma, macular degeneration, diabetic retinopathy. * 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 Investigator.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is tracking brain health markers like NfL, GFAP, and pTau in the blood — can you explain what these biomarkers actually measure, and what it would mean for me if my levels were to change during the study?
2The trial also uses Optical Coherence Tomography and EEG to look at the eyes and brain — are these tests safe and non-invasive, and how time-consuming would it be to complete all of these measurements at each visit?
3Since this study is listed as Phase NA and appears to be observational rather than a treatment trial, does participating in it actually change anything about my care, or would I just be contributing data while continuing whatever treatment plan I already have?
4Given that this research focuses on repetitive head impacts, would you say my own history of head impacts makes this study relevant to my situation, and is there anything about my current health that might make these measurements harder to interpret?
5Are there any standard-of-care evaluations or interventions I should be considering right now for my head impact history, and would joining this study delay or interfere with pursuing those options?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Blood Biomarkers - NfL

Timeframe: Baseline, 24 hours following the final heading session, 14 days following the final heading session

Blood Biomarkers - GFAP

Timeframe: Baseline, 24 hours following the final heading session, 14 days following the final heading session

Blood Biomarkers - pTau

Timeframe: Baseline, 24 hours following the final heading session, 14 days following the final heading session

Optical Coherence Tomography/Angiography (OCT/A) 1

Timeframe: Baseline, 24 hours following the final heading session, 14 days following the final heading session

Optical Coherence Tomography/Angiography (OCT/A) 2

Timeframe: Baseline, 24 hours following the final heading session, 14 days following the final heading session

Optical Coherence Tomography/Angiography (OCT/A) 3

Timeframe: Baseline, 24 hours following the final heading session, 14 days following the final heading session

Trial details

NCT IDNCT07010887

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09

Contact for this trial

Keisuke Kawata, PhD

812-855-5244 kkawata@indiana.edu

View on ClinicalTrials.gov More Repetitive Head Impacts trials

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Blood Biomarkers - NfL

Timeframe: Baseline, 24 hours following the final heading session, 14 days following the final heading session

Blood Biomarkers - GFAP

Timeframe: Baseline, 24 hours following the final heading session, 14 days following the final heading session

Blood Biomarkers - pTau

Timeframe: Baseline, 24 hours following the final heading session, 14 days following the final heading session

Optical Coherence Tomography/Angiography (OCT/A) 1

Timeframe: Baseline, 24 hours following the final heading session, 14 days following the final heading session

Optical Coherence Tomography/Angiography (OCT/A) 2

Timeframe: Baseline, 24 hours following the final heading session, 14 days following the final heading session

Optical Coherence Tomography/Angiography (OCT/A) 3

Timeframe: Baseline, 24 hours following the final heading session, 14 days following the final heading session