Interval Effects for Concussion Prevention

Overseen By Blair Johnson, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Recent head injury, Eye diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 4 weeks

102 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Keisuke Kawata, PhD

Principal Investigator

Indiana University Bloomington Department of Kineseology

Are You a Good Fit for This Trial?

This trial is for current soccer players with at least 5 years of experience in heading the ball. They must be able to consent without a representative. Those who've had recent head injuries or eye conditions like glaucoma that could affect study results can't participate.

Inclusion Criteria

Current soccer player (intercollegiate, club, intramural, recreational)

At least 5 years of soccer heading experience

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

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

I have an eye condition affecting my eye's blood vessels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo repetitive head impacts with varying intervals (24 hours or 72 hours) over 4 weeks

4 weeks

Twice per week

Follow-up

Participants are monitored for changes in blood biomarkers, retinal and ocular-motor health, and EEG signals

2 weeks

Baseline, 24 hours after final session, 14 days after final session

What Are the Treatments Tested in This Trial?

Interventions

• Long Interval
• Short Interval

Trial Overview The study aims to understand how different time intervals between repetitive subconcussive head impacts influence brain health in military service members, using short and long intervals as variables.

How Is the Trial Designed?

Group I: Short Interval - heading Experimental Treatment 1 Intervention

Participants in the heading group will undergo 16 soccer headings, twice per week, with 24 hours in between each session.

Group II: Long Interval - heading Experimental Treatment 1 Intervention

Participants in the heading group will undergo 16 soccer headings, twice per week, with 72 hours in between each session.

Group III: Short Interval - kicking Placebo Group 1 Intervention

Participants in the kicking-control group will undergo 16 soccer kicking, twice per week, with 24 hours in between each session.

Group IV: Long Interval - kicking Placebo Group 1 Intervention

Participants in the kicking-control group will undergo 16 soccer kicking, twice per week, with 72 hours in between each session.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

University of Rochester

Collaborator

Trials

883

Recruited

555,000+

University at Buffalo

Collaborator

Trials

139

Recruited

105,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+